Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids, 50698-50762 [2022-17230]
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Federal Register / Vol. 87, No. 158 / Wednesday, August 17, 2022 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 800, 801, 808, and 874
[Docket No. FDA–2021–N–0555]
RIN 0910–AI21
Medical Devices; Ear, Nose, and Throat
Devices; Establishing Over-theCounter Hearing Aids
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Final rule.
AGENCY:
The Food and Drug
Administration (FDA, we, or the
Agency) is establishing a regulatory
category for over-the-counter (OTC)
hearing aids and making related
amendments to update the regulatory
framework for hearing aids. Specifically,
we define OTC hearing aids and
establish applicable requirements;
amend existing rules for consistency
with the new OTC category; repeal the
conditions for sale applicable to hearing
aids; amend the existing labeling
requirements for hearing aids; and
update regulations relating to decisions
on applications for exemption from
Federal preemption that will become
obsolete as a result of changes to the
hearing aid requirements. In creating a
regulatory category for OTC hearing aids
and amending existing rules, we intend
to provide reasonable assurance of
safety and effectiveness for these
devices as well as foster access to, and
innovation in, hearing aid technology,
thereby protecting and promoting the
public health.
DATES:
Effective date: This rule is effective
October 17, 2022.
Compliance dates: For hearing aids
that have been legally offered for sale
prior to October 17, 2022, including
hearing aids that already have a 510(k)
clearance, compliance with the new or
revised requirements must be achieved
by April 14, 2023. For hearing aids that
have not been offered for sale prior to
October 17, 2022, or have been offered
for sale but are required to submit a new
510(k) due to changes unrelated to this
rule, compliance with the new or
revised requirements applicable to the
hearing aid, and obtaining 510(k)
clearance if applicable, must be
achieved before marketing the device on
or after October 17, 2022.
Incorporation by reference: The
incorporation by reference of certain
material listed in this rule is approved
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SUMMARY:
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by the Director of the Federal Register
as of October 17, 2022.
ADDRESSES: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this final rule, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
With regard to the final rule: Srinivas
Nandkumar, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 301–
796–6480, Srinivas.Nandkumar@
fda.hhs.gov.
With regard to the information
collection: Amber Sanford, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
8867, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
Purpose of the Final Rule
Summary of the Major Provisions of the
Final Rule
Legal Authority
Costs and Benefits
II. Table of Abbreviations and Acronyms
Commonly Used in this Document
III. Background
A. Need for the Regulation
B. History of this Rulemaking and Public
Participation
C. Summary of Changes Between Proposed
and Final Rules
D. Incorporation by Reference
IV. Legal Authority
V. Comments on the Proposed Rule and
FDA’s Responses
A. Device Classification and Marketing
B. Scope (§ 800.30(a))
C. Definitions (§§ 800.30(b) and 801.422(b))
D. Labeling (§ 800.30(c))
E. Output Limits (§ 800.30(d))
F. Other Device Requirements (§ 800.30(e)
and (f))
G. Conditions for OTC Sale (§ 800.30(g))
H. Preemption Provisions (§ 800.30(h))
I. Repeal of Restrictions and Modifications
for Prescription Labeling (§§ 801.420,
801.421, 801.422)
J. Other Amendments
VI. Effective and Compliance Dates
A. Effective Date
B. Compliance Dates for Hearing Aids Not
Legally Offered for Sale Prior to the
Effective Date
C. Compliance Dates for Hearing Aids
Legally Offered for Sale Prior to the
Effective Date
VII. Economic Analysis of Impacts
VIII. Analysis of Environment Impact
IX. Paperwork Reduction Act of 1995
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X. Federalism
XI. Consultation and Coordination with
Indian Tribal Governments
XII. References
I. Executive Summary
A. Purpose of the Final Rule
Hearing loss affects an estimated 30
million people in the United States and
can have a significant impact on
communication, social participation,
and overall health and quality of life.
Despite the high prevalence and public
health impact of hearing loss, only
about one-fifth of people who could
benefit from a hearing aid seek
intervention. Several barriers likely
impede the use of hearing aids in
hearing-impaired individuals such as
high cost, stigma of being perceived as
old or debilitated, and value (perceived
hearing benefit relative to price). FDA is
finalizing rules to address some of these
concerns.
Moreover, the FDA Reauthorization
Act of 2017 (FDARA) (Pub. L. 115–52)
directs FDA to establish a category of
OTC hearing aids through rulemaking,
and FDARA sets forth various
requirements for OTC hearing aids,
including for reasonable assurance of
safety and effectiveness, as well as
Federal preemption provisions. In
addition to protecting and promoting
the public health, these rules establish
the OTC category and implement the
requirements of FDARA.
B. Summary of the Major Provisions of
the Final Rule
FDA is establishing a regulatory
category for OTC hearing aids to
improve access to hearing aid
technology for Americans. OTC hearing
aids are intended to address perceived
mild to moderate hearing loss in people
aged 18 or older. Along with the OTC
category, we are finalizing multiple
related changes to the overall regulatory
framework for hearing aids to
harmonize existing rules with the new
OTC category. We have determined that
the requirements set forth in this
rulemaking will protect the public
health by providing reasonable
assurance of safety and effectiveness for
hearing aids, as well as promote the
hearing health of Americans by
lowering barriers to access and fostering
innovation in hearing aid technology.
Among other things, FDARA
amended the Federal Food, Drug, and
Cosmetic Act (FD&C Act) by defining
OTC hearing aids and providing the
authorities to establish the OTC category
of hearing aids among provisions that
are, by definition, general controls. We
are finalizing general controls for OTC
hearing aids consistent with FDARA.
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We are finalizing lower output limits
than we proposed but have not
substantially changed the other
electroacoustic performance
requirements for OTC hearing aids. We
have simplified the phrasing throughout
the required labeling and have restated
the maximum insertion depth for OTC
hearing aids in terms of a fixed
measurement. However, we are not
realigning the air-conduction hearing
aid classification regulations as
proposed.
This rulemaking also affects other
regulations that applied to hearing aids.
FDA had established device restrictions
for hearing aids that included labeling
requirements as well as conditions for
sale. We are removing these device
restrictions for hearing aids and
establishing a new regulation for
prescription hearing aid labeling.
Further, FDA had by regulation granted
or denied exemptions from Federal
preemption for State requirements
pertaining to hearing aids. The removal
of the device restrictions on hearing
aids, as well as certain provisions of
FDARA, impact most of these previous
exemption decisions, for example, by
altering their scope. We are removing
the regulations codifying these
decisions and establishing other
regulations clarifying some of the effects
of statutory preemption under FDARA.
C. Legal Authority
The FD&C Act establishes a
comprehensive system for the regulation
of devices intended for human use.
Hearing aids are devices intended for
human use and so are subject to, among
other requirements, the device
provisions of the FD&C Act. FDA has
authority to establish regulatory controls
needed to provide reasonable assurance
of safety and effectiveness for these
devices. As such, FDA is establishing
regulatory controls for OTC hearing aids
and amending regulatory controls for
prescription hearing aids. Moreover, the
FD&C Act directs the establishment of
an electronic radiation control program,
and hearing aids and personal sound
amplification products (PSAPs) are
electronic products, subject to the
electronic radiation control
requirements.
Specific to OTC hearing aids, the
FD&C Act and FDARA authorize
multiple controls, including authority
for FDA to establish requirements for
device labeling, output limits,
conditions for sale and distribution, and
other requirements that provide
reasonable assurance of safety and
effectiveness of OTC hearing aids.
FDARA specifically directs FDA to
establish a category of OTC hearing aids
by regulation that must include the
aforementioned requirements.
More generally, the FD&C Act further
provides for labeling requirements as
general controls such that devices (and
other medical products) will not be
misbranded. The FD&C Act also
authorizes FDA to issue regulations for
the efficient enforcement of the FD&C
Act. We are establishing the following
regulations pursuant to these authorities
and to fulfill the directive under
FDARA.
Additionally, both the FD&C Act and
FDARA include preemption provisions
applicable to hearing aids.
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Abbreviation/acronym
510(k) ...................................
ANSI .....................................
APA ......................................
ASA ......................................
ASHA ....................................
CDRH ...................................
CFR ......................................
cm3 .......................................
CTA ......................................
dB .........................................
dBA .......................................
EA .........................................
ENT ......................................
FDA ......................................
FD&C Act .............................
FDARA .................................
FONSI ..................................
FR .........................................
FRIA .....................................
IQA .......................................
ISO .......................................
ITU ........................................
mm .......................................
ms .........................................
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D. Costs and Benefits
This rule to establish OTC hearing
aids and align other regulations
generates potential cost savings for
consumers with perceived mild to
moderate hearing impairment who wish
to buy lower cost hearing aids not
bundled with professional services and
not requiring professional advice,
fitting, adjustment, or maintenance but
who are currently unable to buy such
products online because of State
regulations or because they do not shop
online. This rule also generates costs for
hearing aid manufacturers for changing
labeling of existing hearing aids as well
as for reading the rule and revising
internal standard operating procedures
in response to the rule. We estimate
benefits of between $6 million and $147
million per year based on 5th and 95th
percentile Monte Carlo results with a
mean of $63 million per year. We
estimate annualized costs of between $1
million and $2 million per year based
on 5th and 95th percentile Monte Carlo
results with a mean of $1 million per
year. Combining benefits and costs, we
used Monte Carlo analysis to estimate
annualized net benefits of between $5
million and $145 million per year based
on the 5th and 95th Monte Carlo
percentile results with a mean of $62
million per year at both 3 percent and
7 percent discount rates.
II. Table of Abbreviations and
Acronyms Commonly Used in This
Document
What it means
A premarket notification for certain devices.
American National Standards Institute.
Administrative Procedure Act.
Acoustical Society of America.
American Speech-Language-Hearing Association.
Center for Devices and Radiological Health.
Code of Federal Regulations.
Centimeter cubed (cubic centimeter).
Consumer Technology Association.
Decibel.
A-weighted decibel.
Environmental assessment.
Ear-Nose-Throat.
Food and Drug Administration.
Federal Food, Drug, and Cosmetic Act.
FDA Reauthorization Act of 2017.
Finding of no significant impact.
Federal Register.
Final Regulatory Impact Analysis.
Information Quality Act.
International Organization for Standardization.
International Telecommunication Union.
Millimeter.
Millisecond.
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Abbreviation/acronym
MSW .....................................
NASEM .................................
NIOSH ..................................
OMB .....................................
OSPL90 ................................
OTC ......................................
PRA ......................................
PSAP ....................................
Pub. L ...................................
RMS .....................................
SPL .......................................
U.S.C ....................................
WHO .....................................
What it means
Municipal solid waste.
National Academies of Sciences, Engineering, and Medicine.
National Institute for Occupational Safety and Health.
Office of Management and Budget.
Output sound pressure level with 90-dB input.
Over-the-counter.
Paperwork Reduction Act of 1995.
Personal sound amplification product.
Public Law.
Root mean square.
Sound pressure level.
United States Code.
World Health Organization.
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III. Background
FDA is defining and establishing
general controls for an OTC category of
hearing aids. We intend these controls
to provide for reasonable assurance of
safety and effectiveness for these
devices, thereby protecting the public
health. We also intend these controls to
help improve access to and foster
innovation in hearing aid technology for
Americans, thereby promoting the
public health. We are making various
other revisions, as described in this
document, to align existing regulations
with statutory requirements and the
new OTC category.
For brevity, we will use the following
terms as shorthand in this document:
‘‘Over-the-Counter Hearing Aid
Controls’’ for the general controls for
OTC hearing aids that we are finalizing
under § 800.30 (21 CFR 800.30).
‘‘Commercial activity involving OTC
hearing aids’’ to refer to any or all of the
following activities: servicing,
marketing, sale, dispensing, use,
customer support, or distribution of
OTC hearing aids through in-person
transactions, by mail, or online.
‘‘Customizable’’ or ‘‘customization,’’
unless otherwise noted, to refer to the
elements of the statutory definition for
OTC hearing aids described in section
520(q)(1)(A)(iii) and (iv) of the FD&C
Act (21 U.S.C. 360j(q)(1)(A)(iii) and
(iv)). That is, for the purposes of this
document, a customizable hearing aid is
one that, through tools, tests, or
software, allows the user to control the
hearing aid and customize it to the
user’s hearing needs. To do so, the
hearing aid may use wireless technology
or include tests for self-assessment of
hearing loss. (See also the response to
Comment 1 explaining customization in
more technical terms.)
‘‘Involvement of a licensed person’’ to
refer to the supervision, prescription, or
other order, involvement, or
intervention of a licensed person.
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‘‘State or local requirement’’ to refer
to any State or local law, regulation,
order, or other requirement.
A. Need for the Regulation
Hearing loss affects an estimated 30
million people in the United States and
can have a significant impact on
communication, social participation,
and overall health and quality of life
(Refs. 1 and 2). Despite the high
prevalence and public health impact of
hearing loss, only about one-fifth of
people who could benefit from a hearing
aid seek intervention (Ref. 3). The use
of hearing aids has been linked to,
among other health benefits, reductions
in the incidence or severity of cognitive
decline, depression, and other health
problems in older adults (Refs. 2, 4, and
5). Additionally, benefits of hearing aid
use can include improved social
participation and a better quality of life.
Besides health benefits for
individuals, more-widespread adoption
of hearing aids could have broader
effects. By increasing social
participation, hearing aids could help to
improve inclusion of individuals in
family, economic, civic, and religious
life. Thus, reducing barriers to hearing
aid access might contribute to such
improvements. This could be
particularly true for people of color,
rural Americans, low-income
individuals, and others for whom
barriers to hearing aid access may be
especially burdensome.
Several barriers likely impede the use
of hearing aids in hearing-impaired
individuals such as high cost, stigma of
being perceived as old or debilitated,
and value (perceived hearing benefit
relative to price) (Ref. 6). FDA is
finalizing rules to address some of these
concerns.
Moreover, section 709 of FDARA
directs FDA to establish a category of
OTC hearing aids through rulemaking,
and sets forth various requirements for
OTC hearing aids, including for
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reasonable assurance of safety and
effectiveness, as well as Federal
preemption provisions. In addition to
protecting and promoting the public
health, these rules establish the OTC
category and implement the
requirements of FDARA.
B. History of This Rulemaking and
Public Participation
On October 20, 2021, in the Federal
Register, FDA proposed multiple
regulatory changes, including proposing
requirements for OTC hearing aids, that
would serve to provide reasonable
assurance of safety and effectiveness of
hearing aids, address barriers to access
to hearing aids, and effectuate the
requirements of section 709 of FDARA
(86 FR 58150). Although the October
2021 proposal was the first step in this
rulemaking, the proposal followed other
steps FDA had already taken to initiate
an update of the regulatory framework
for hearing aids. Please refer to the
aforementioned issue of the Federal
Register for further details on the
proposal and other steps taken by FDA.
We received more than 1,000
comments on the proposed rule by the
close of the comment period, which was
January 18, 2022. Commenters included
consumers, professionals, professional
associations, hearing aid manufacturers,
public health organizations, public
advocacy groups, members of Congress,
and State agencies. We describe and
respond to the comments in section V
of this document. We have grouped
similar comments together under the
same number, and in some cases, we
have separated different issues
discussed in the same comment and
designated them as distinct comments
for purposes of our responses. The
number assigned to each comment or
comment topic is purely for
organizational purposes and does not
signify the comment’s value or
importance or the order in which we
received comments.
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C. Summary of Changes Between
Proposed and Final Rules
In response to comments, we have
made (and declined) a number of
changes for the final rule. The following
summarizes the outcomes that may be of
greatest interest to readers:
Output limits. We are finalizing lower
output limits than we proposed. The
general limit will be 111 decibels of
sound pressure level (dB SPL), with 117
dB SPL allowable for devices while
input-controlled compression is
activated.
Gain limit. We did not propose, and
are not finalizing, a separate gain limit.
Design requirements. We have revised
the allowable insertion depth. The most
medial (innermost) component of an
OTC hearing aid must be reasonably
expected to remain at least 10
millimeters (mm) from the tympanic
membrane (eardrum). We are also
requiring that all OTC hearing aids have
a user-adjustable volume control.
Labeling. We have improved phrasing
throughout the labeling to make it more
understandable for hearing aid users
(non-experts).
Conditions for sale. We are not
requiring age verification for the sale of
OTC hearing aids. Prescription hearing
aid sales will be subject to the
requirements in § 801.109 (21 CFR
801.109), including that they be sold
only to or on the prescription or other
order of a practitioner licensed by law
to use or order the use of (prescribe) the
devices (which is as proposed).
Scope and definitions. Perceived mild
to moderate hearing impairment
remains the scope of the intended use
of OTC hearing aids, and we are
declining to require measurements of
hearing loss to establish prospective
users’ qualification to purchase OTC
hearing aids.
OTC category and self-fitting airconduction hearing aid classification.
We are not requiring that OTC hearing
aids be self-fitting devices, and we have
provided clarification on the difference
between customization and fitting.
Quality System requirements. OTC
hearing aids will be subject to the
requirements under part 820 (21 CFR
part 820), which describes a quality
management system appropriate for
medical devices.
We explain those decisions and
others, as well as provide our thinking
on other topics in the sections that
follow.
D. Incorporation by Reference
FDA is incorporating by reference
ANSI/CTA–2051, ‘‘Personal Sound
Amplification Performance Criteria,’’
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dated January 2017, which was
approved by the Office of the Federal
Register. You may obtain a copy from
the Consumer Technology Association
(CTA), 1919 S. Eads St., Arlington, VA
22202; https://www.cta.tech, 703–907–
7600. Among other things, it describes
how to measure frequency response and
includes technical data for adaptations
for different circumstances and provides
a standardized way to quantify
frequency response for OTC hearing
aids and to meet the related
electroacoustic performance
requirements.
FDA is also incorporating by reference
ANSI/ASA S3.22–2014 (R2020),
‘‘Specification of Hearing Aid
Characteristics,’’ dated June 5, 2020,
which was approved by the Office of the
Federal Register. You may obtain a copy
from the Acoustical Society of America
(ASA), 1305 Walt Whitman Road, Suite
300, Melville, NY 11747 Telephone: 1
(631) 390–0215, Fax: 1 (631) 923–2875,
Email: asastds@acousticalsociety.org or
the American National Standards
Institute (ANSI), 1889 L Street NW, 11th
Floor, Washington, DC 20036; https://
www.ansi.org, 202–293–8020. ANSI/
ASA S3.22–2014 (R2020) describes
tolerances and test methods used for
certain measurements of hearing aid
performance. The application of ANSI/
ASA S3.22–2014 (R2020) provides
professional hearing instrument
specialists with standardized technical
information to help them select the
correct hearing aid and ensure optimal
fit and performance for hearing aid
users.
IV. Legal Authority
The FD&C Act establishes a
comprehensive system for the regulation
of devices, as defined in section 201(h)
of the FD&C Act (21 U.S.C. 321(h)),
intended for human use. Section 513 of
the FD&C Act (21 U.S.C. 360c) defines
three classes of devices, reflecting the
regulatory controls needed to provide
reasonable assurance of their safety and
effectiveness. The three classes of
devices are class I (general controls),
class II (special controls), and class III
(premarket approval) (see 21 U.S.C.
360c). Hearing aids are devices intended
for human use and are subject to the
FD&C Act. Currently, air-conduction
hearing aids are generally either class I
or class II devices.
The FD&C Act also directs the
establishment of an electronic product
radiation control program under section
532(a) to protect the public health and
safety (see 21 U.S.C. 360ii(a)), and
requires, among other things, that
manufacturers of electronic products
provide notification of certain defects
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(see 21 U.S.C. 360ll). Section 531(1)(B)
of the FD&C Act defines electronic
product radiation as, among other
phenomena, any sonic, infrasonic, or
ultrasonic wave emitted from an
electronic product as the result of the
operation of an electronic circuit (see 21
U.S.C. 360hh(1)(B)). In turn, any
manufactured or assembled product
which, when in operation, contains or
acts as part of an electronic circuit and
emits (or in the absence of effective
shielding or other controls would emit)
electronic product radiation would be
an electronic product (see 21 U.S.C.
360hh(2)(A)). As such, hearing aids and
PSAPs emit electronic product radiation
and are electronic products, meaning
they are subject to the electronic
product radiation control requirements.
FDARA amended the FD&C Act to
apply requirements specific to certain
hearing aids and defined the term ‘‘overthe-counter hearing aid’’ (see 21 U.S.C.
360j(q)). We are issuing these
requirements for OTC hearing aids
pursuant to section 709(b) of FDARA,
which authorizes FDA to establish
requirements for labeling, output limits,
conditions for sale and distribution of
OTC hearing aids, and other
requirements that provide for reasonable
assurance of safety and effectiveness of
these devices.
In addition, the FD&C Act provides
that a device is misbranded unless,
among other requirements, its labeling
bears adequate directions for use (see
section 502(f)(1) of the FD&C Act (21
U.S.C. 352(f)(1)). Consistent with
section 502 of the FD&C Act, FDA has
issued regulations that exempt certain
kinds of devices from the requirement
for adequate directions for use. Section
502(f)(2) further requires adequate
warnings against use of a device in
those pathological conditions, or by
children, where use of the device may
be dangerous to health. The labeling
must also bear adequate warnings
against unsafe dosage or methods or
duration of administration or
application (see section 502(f)(2) of the
FD&C Act). Such warnings must be in
such manner and form as are necessary
for the protection of the users (see
section 502(f)(2) of the FD&C Act).
A device is also misbranded if its
labeling is false or misleading in any
particular (see section 502(a) of the
FD&C Act). Section 201(n) of the FD&C
Act states that in determining whether
labeling or advertising is misleading,
there shall be taken into account not
only representations made or suggested
but also the extent to which labeling or
advertising fails to reveal material facts.
Other misbranding provisions under
the FD&C Act would apply as well,
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including section 502(c), which deems a
device to be misbranded if any word,
statement, or other information required
by or under authority of the FD&C Act
to appear on the label or labeling is not
prominently placed thereon with such
conspicuousness and in such terms as to
render it likely to be read and
understood by the ordinary individual
under customary conditions of purchase
and use.
Additionally, section 701(a) of the
FD&C Act authorizes FDA to issue
regulations for the efficient enforcement
of the FD&C Act (21 U.S.C. 371(a)). The
regulations established in this
rulemaking are for the efficient
enforcement of the FD&C Act because
they will provide standards for the legal
marketing of safe and effective hearing
aids.
Violations of any final rules from this
rulemaking, once in effect, would
render the hearing aids adulterated and/
or misbranded under sections 501 and/
or 502 of the FD&C Act, and subject to
enforcement action, for example, seizure
(see section 304 of the FD&C Act (21
U.S.C. 334)), injunction (see section 302
of the FD&C Act (21 U.S.C. 332)), and
criminal prosecution (see section 303 of
the FD&C Act (21 U.S.C. 333)).
Prohibited acts include, among others,
introducing an adulterated or
misbranded device into interstate
commerce (see section 301 of the FD&C
Act (21 U.S.C. 331)). Sections 538 and
539 of the FD&C Act additionally set
forth prohibited acts and provisions for
enforcement for electronic product
radiation control (see 21 U.S.C. 360oo
and 360pp, respectively).
Under section 521 of the FD&C Act,
no State or political subdivision of a
State may establish or continue in effect
with respect to a device intended for
human use any requirement that is
different from, or in addition to, any
requirement applicable under the FD&C
Act to the device and that relates to the
safety or effectiveness of the device or
to any other matter included in a
requirement applicable to the device
under the FD&C Act (21 U.S.C. 360k).
Section 521 of the FD&C Act also
provides that FDA may grant an
exemption from preemption under
certain circumstances. Section 709(b) of
FDARA also includes a preemption
provision with respect to requirements
for OTC hearing aids.
V. Comments on the Proposed Rule and
FDA’s Responses
In the proposed rule, FDA welcomed
comments on all aspects of the proposal,
and we specifically requested comments
on certain topics to encourage moretargeted feedback. Such topics included:
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the clarity of the definitions and ways to
improve them;
labeling requirements;
equitable access to hearing aids and
information about them;
whether State or local requirements for
returns would promote or restrict or interfere
with commercial activities involving OTC
hearing aids;
design requirements to limit insertion
depth;
proposals for modification of, or
alternatives to, the current applicable Quality
System requirements for OTC hearing aids;
conditions for sale of OTC hearing aids to
prevent sale to or for people younger than 18;
the removal of regulations in 21 CFR part
808 (part 808) regarding exemptions from
Federal preemption for State and local
requirements respecting hearing aids;
possible effects of the rule on small
manufacturers;
data concerning the environmental
assessment and our proposal for a finding of
no significant impact (FONSI);
topics related to the Paperwork Reduction
Act of 1995 (PRA) and associated estimates
for recordkeeping burdens; and
potential impacts on Indian Tribes from
this rulemaking.
As appropriate, we summarize such
comments that we received, along with
other pertinent comments, and respond
to them in the corresponding
subsections that follow. As we indicated
in the proposal, we considered only
comments submitted to the docket for
this rulemaking that were timely and
pertinent (see 86 FR 58150–58161).
The vast majority of comments that
we received supported rulemaking to
encourage wider adoption of safe and
effective hearing aids for people who
could benefit from them. FDA agrees
that rulemaking can encourage wider
adoption of such devices, and we expect
this final rule to do so. Many
commenters conveyed enthusiasm for
affordable hearing aids and/or wider
availability without the involvement of
a licensed person, telling us that they
expect the difference to make hearing
aids accessible to them—in some cases,
for the first time. Some comments
observed that hearing impairment often
correlates with lower income,
suggesting that lower prices may be
particularly helpful for people who may
want to use hearing aids and that OTC
hearing aids could serve an important
role in achieving equitable health
outcomes.
Still, many commenters voiced both
support and concern for the role of
licensed persons and the value of
professional services for hearing health.
In finalizing this rule, FDA is not
suggesting that licensed persons or their
professional services are unimportant or
not valuable. Indeed, we recommend
consulting licensed persons in several
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circumstances, including for the
diagnosis of hearing impairment and in
the fitting and continued use of OTC
hearing aids when consumers choose to
seek such services. Many commenters
asserted that the professional services
are worth the cost. In that vein, one
comment suggested that, like providing
alternative distribution channels,
increasing the number of audiologists
and other hearing health care providers
would also improve accessibility. This
final rule, however, focuses on subjects
within FDA’s purview, establishing
device requirements that provide
reasonable assurance of safety and
effectiveness for OTC hearing aids
without the involvement of a licensed
person, as directed by FDARA.
As for specific provisions, the
comments generally supported
establishing requirements for labeling,
output (volume) limits, electroacoustic
performance requirements, and other
design requirements for OTC hearing
aids. However, individual comments
varied on the extent to which they
supported specific proposals or
proffered alternatives. Comments that
provided a rationale and/or evidence
generally lent more insight for FDA’s
consideration.
We acknowledge that some comments
did not support this rulemaking, many
of them stating that hearing aids are
medical devices and should not be
regulated as consumer electronics. We
interpret such comments to mean that
OTC hearing aids should not have a
relaxed standard for safety or
effectiveness, nor should OTC hearing
aids be subject to less stringent
requirements for product quality than
other medical devices. We agree that
OTC hearing aids must meet the same
standard as other devices for having
reasonable assurance of safety and
effectiveness, consistent with the FD&C
Act and section 709 of FDARA, and that
OTC hearing aids be subject to the
quality system requirements applicable
to other devices. However, we note that
different device types and categories
will raise different issues related to
safety and effectiveness. Thus, while
devices must meet the same standard of
having reasonable assurance of safety
and effectiveness, different device types
and categories can engender different
regulatory requirements to achieve the
same standard. This final rule
establishes requirements specific to
hearing aids and although the
requirements for OTC and prescription
hearing aids are not the same, these
requirements, along with other
applicable requirements under the
FD&C Act, provide for reasonable
assurance of safety and effectiveness for
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both categories of hearing aids (we note
that in this document when we describe
the requirements in § 800.30 (21 CFR
800.30) or § 801.422 (21 CFR 801.422) as
providing reasonable assurance of safety
and effectiveness, we mean in
conjunction with other applicable
requirements under the FD&C Act).
A. Device Classification and Marketing
We received several comments about
the interplay among device
classification regulations, the OTC
Hearing Aid Controls, and premarket
notification requirements. Generally, we
agree that clarification on such issues
will help ensure that manufacturers
identify and follow the appropriate
regulatory requirements for their
devices.
(Comment 1) Multiple comments
requested clarification on the difference
between self-fitting hearing aids
classified under § 874.3325 (21 CFR
874.3325) and hearing aids that, through
tools, tests, or software allow users to
control the hearing aids and customize
them to the users’ hearing needs. Many
such comments pointed out that the
clarification will help manufacturers
determine the applicability of premarket
notification requirements and special
controls.
(Response) Under section 520(q)(1)(A)
of the FD&C Act, an OTC hearing aid
must be controllable by the user and
customizable to the user’s hearing
needs. We interpret the requirement for
customization to hearing needs to mean
that the device must allow the user to
cause frequency-dependent changes
based on the user’s preference. This is
because a single profile for gain versus
frequency is unlikely to accommodate
the majority of hearing needs for
perceived mild to moderate impairment.
For example, a flat gain profile across
frequency is unlikely to meet the
hearing needs of users with sloping
hearing loss, the kind of impairment
often associated with aging, as well as
a non-flat gain profile across frequency
would. However, a flat gain profile
across frequency may be preferable for
some people with a different kind of
hearing loss. In short, to have reasonable
assurance of safety and effectiveness of
OTC hearing aids, the devices must offer
capabilities for a variety of perceived
mild to moderate hearing impairments,
and customization is the method or
process that allows the user to match
the device output to individual
preference.
We interpret the requirement for user
control to mean that the user can access
or select the output characteristics most
significant to the user’s hearing
perception. For an OTC hearing aid, we
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consider these characteristics to include
the frequency-dependent output profile
and the output volume. The controls
must allow the user to select the output
volume and profile according to
preference. The user may control the
output profile, for example, with a
physical toggle switch, a selection
through a software interface, or
providing preferences for software to
select the optimal profile dynamically.
FDA views customization as a moregeneral concept than self-fitting. Fitting
is a customization process that instills
in the device frequency-dependent
settings for the specific user. A selffitting process instills frequencydependent settings through the user
interacting with the device or an
accessory to the device. Self-fitting
hearing aids incorporate technology,
including software, that integrates user
input with a self-fitting strategy and
enables users to independently derive
and customize their hearing aid fitting
and settings (see § 874.3325(a)). A selffitting strategy is a fitting process, with
the selected output profile intended to
correspond to the user’s audiogram
more closely than a hearing aid that is
not fitted. Many hearing aids that are
customizable but not fitted have a
limited set of standardized output
profiles, often called ‘‘presets.’’
In considering whether a hearing aid
is self-fitting, FDA takes into account,
among other things, the device’s design
and labeling. For purposes of
distinguishing fitting a hearing aid from
selecting among standardized output
profiles, we focus on the determination
and configuration of device settings that
would be appropriate for the specific
user, especially the frequencydependent settings. (However, this focus
does not exclude other factors that
would still be relevant to determining
intended use.) For example, a hearing
aid outputting a preset likely would not
be self-fitting, but a hearing aid that
allowed the user to make frequencydependent modifications to a preset to
suit the user’s preferences likely would
be self-fitting.
FDA recognizes that, because a preset
may approach a user’s ideal fitting, a
device with several presets may be
difficult to distinguish from a self-fitting
device. However, we note that devices
with a small number of presets, for
example, three, are not ordinarily
considered self-fitting when the user
chooses the profile. However, a hearing
aid with a greater number of profiles
would more closely resemble a fitting
process, with the selected output profile
intended to correspond to the user’s
audiogram more closely, in which case
the hearing aid likely would be
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considered self-fitting. Similarly,
toggling between a small number of
programs, for example, for noise
reduction or scene selection, would
generally not indicate self-fitting, but
setting or adjusting compression knee
points in frequency sub-bands, would
tend to indicate self-fitting. Moreover,
FDA would likely consider a device that
includes self-fitting functionality to be
self-fitting, regardless of whether the
individual user takes advantage of the
functionality.
In sum, customization need not entail
self-fitting, though self-fitting is a kind
of customization. Whether a hearing aid
is self-fitting depends on its intended
use, which may be shown by, among
other things, the device’s design and
labeling (see § 801.4 (21 CFR 801.4)).
Some limited feature sets would not
ordinarily cause a device to be a selffitting hearing aid, while more advanced
adjustment capability, especially for
frequency-dependent settings, would
tend to indicate that the device is a selffitting hearing aid. FDA has made a
minor revision to the requirement to
provide specific instructions for use of
tools, tests, or software to clarify that
such instructions need not always refer
to self-fitting; such instructions must
include instructions for self-fitting only
when the OTC hearing aid is a selffitting device (see final
§ 800.30(c)(2)(vii)(B)).
(Comment 2) Many comments urged
FDA: to clarify that the definition of
OTC hearing aids under section
520(q)(1)(A) of the FD&C Act is
synonymous with the identification for
self-fitting air-conduction hearing aids
under § 874.3325(a); to declare that selffitting hearing aids are OTC devices; to
declare that OTC hearing aids must be
self-fitting; and/or to require that OTC
hearing aid labeling bear the description
‘‘self-fitting’’ or a similar description.
(Response) Although FDA expects
that many OTC hearing aids will be selffitting, we do not agree with these
comments. As explained in the response
to Comment 1, a hearing aid may be
customizable in the manner required
under section 520(q)(1)(A)(iii) of the
FD&C Act yet not be intended to entail
fitting. Thus, we are not requiring that
OTC hearing aids be self-fitting devices.
By extension, we are not requiring in
this final rule that OTC hearing aids
bear labeling that describes the devices
as ‘‘self-fitting’’ or a similar description.
However, § 801.61 (21 CFR 801.61) still
applies, and this provision requires,
among other things, a statement of
identity on the principal display panel
of an OTC device. (See also the
responses to Comment 21, regarding
other considerations for self-fitting
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capabilities of OTC hearing aids, and
Comment 18, regarding identifying and
selling OTC hearing aids.)
Moreover, FDA intends that any
hearing aid that uses the same
fundamental scientific technology as
those defined under §§ 874.3300(a) (21
CFR 874.3300(a)), 874.3305 (21 CFR
874.3305), and 874.3325 (21 CFR
874.3325) qualify as an OTC hearing aid
(provided it satisfies all other applicable
requirements). Some future hearing aid
device types may also meet the statutory
definition (and satisfy all other
applicable requirements) to be available
over the counter. Requiring that OTC
hearing aids be a currently classified airconduction hearing aid could have the
effect of limiting the OTC category to
current technologies rather than
allowing the category to extend to new
types of hearing aids.
(Comment 3) Some comments
requested clarification on what would
qualify as ‘‘tools, tests, or software’’ for
the purposes of controlling an OTC
hearing aid and customizing it to the
user’s hearing needs. Similar comments
requested that FDA clarify which legacy
and wireless air-conduction hearing
aids would satisfy the customization
requirement but not be a self-fitting
hearing aid.
(Response) FDA interprets the
requirement for tools, tests, or software
broadly. We would, for example,
consider a device that allows the user to
cycle through output profiles with a
push-button selector switch and to set
the volume with a knob to meet the
requirement. Should such a hearing aid
be sufficiently customizable, and should
it not incorporate wireless or self-fitting
technology, then it would presumably
be an air-conduction (‘‘legacy’’) hearing
aid classified under § 874.3300 and
could be made available OTC. (See the
response to Comment 1 for more about
distinguishing customization and
fitting.)
(Comment 4) Comments expressed
concerns about the potential to bypass
premarket notification requirements and
special controls if non-self-fitting
hearing aids could be later configured or
modified, for example, if the
manufacturer ‘‘unlocks’’ self-fitting
software or provides the user with
options for ‘‘advanced settings’’ or the
like. They urged FDA to finalize rules to
prevent such an outcome.
(Response) Existing requirements
already address modifications to
devices, including hearing aids. Under
§ 807.81(a)(3) (21 CFR 807.81(a)(3)), a
510(k) is required if the device is about
to be significantly changed or modified,
namely, a major change or modification
in the intended use or other kind of
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change or modification that could
significantly affect the safety or
effectiveness of the device. For example,
a change or modification that causes a
device to fall within a different
classification regulation would be
considered significant. Additionally, as
explained in the response to Comment
1, aspects of the device’s design and
labeling can demonstrate the device’s
intended use (see § 801.4). If a wireless
air-conduction hearing aid later
incorporates self-fitting technology (for
example, by downloading software) or
such technology is later made accessible
to the user (for example, by ‘‘unlocking’’
after an additional purchase), such a
change would almost certainly
demonstrate that the modified device
was a self-fitting air-conduction hearing
aid classified under § 874.3325
(assuming it was not a new device type).
As such, it would be subject to the
premarket notification requirements and
special controls that apply to self-fitting
air-conduction hearing aids.
In sum, a change in intended use or
other aspect can cause a change in
applicable requirements, and a device
must comply with applicable regulatory
requirements. As such, if a
manufacturer intends to unlock or
similarly upgrade its hearing aid with
self-fitting technology such that it
would fall within the self-fitting airconduction hearing aid classification
regulation, then prior to initial
introduction into interstate commerce of
the device, the manufacturer must
comply with applicable requirements,
including 510(k) requirements and
compliance with the special controls.
(See also the response to Comment 6
about the information a 510(k) should
include.)
(Comment 5) Several comments
requested clarification on when
manufacturers of OTC hearing aids
would need to submit a premarket
notification, also called a 510(k). Many
of these comments urged FDA to require
510(k)s for all OTC hearing aids.
(Response) FDA’s existing
requirements and related policies for
submitting 510(k)s apply to hearing aids
intended for OTC availability and use.
We are not imposing additional general
requirements for 510(k)s.
For manufacturers that have already
legally introduced self-fitting airconduction hearing aids into interstate
commerce, changes to their devices to
satisfy the OTC Hearing Aid Controls
may require submission of a 510(k).
However, in certain situations FDA
intends not to enforce the requirement
for a 510(k), as discussed in section VI
on effective and compliance dates.
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This policy also applies to non-selffitting devices (wireless air-conduction
and legacy air-conduction hearing aids).
However, manufacturers of non-selffitting devices may wish to consider the
implications of using a test for
somebody besides the user to fit the
device. For devices intended for fitting
based off of a user-supplied audiogram,
a requirement for the involvement of a
licensed person to produce the
audiogram may cause the device not to
be an OTC hearing aid as defined in
section 520(q)(1)(A) of the FD&C Act.
Further, if a manufacturer or other
non-licensed person obtains hearing
ability data to customize (or even fit) a
hearing aid, the manufacturer should
consider whether the instrument used to
obtain the data is a diagnostic (or other)
device. Using a hearing aid with a
diagnostic device may implicate
changes to a hearing aid concerning the
compatibility or interoperability with
other devices, including other
components or accessories, that could
significantly affect the hearing aid’s risk
profile, necessitating a 510(k).
Notwithstanding these general
principles, in each case, manufacturers
should evaluate any changes in light of
FDA’s guidance, ‘‘Deciding When to
Submit a 510(k) for a Change to an
Existing Device,’’ issued October 25,
2017, which describes specific changes
that generally do or do not require
premarket notification.1
To illustrate: If a manufacturer of a
wireless air-conduction hearing aid
updates device labeling and adds a user
self-assessment test intending the test to
enable the user to independently
customize and derive the fitting and
settings (the device is intended to entail
fitting), then FDA would anticipate the
manufacturer would need to submit a
510(k). FDA’s guidance document lists
several considerations that would likely
apply. In this example, the changes
included:
the directions for use, including the
use and application of the self-test to the
device settings (see A4 of the
aforementioned guidance on deciding
when to submit a 510(k), ‘‘Could the
change affect the directions for use of
the device?’’);
the control mechanism and/or
operating principle (see B2 of the same
guidance, ‘‘Is it a control mechanism,
operating principle, or energy type
change?’’);
the device’s design, specifically
changes to its performance, components
1 The document is available online at: https://
www.fda.gov/regulatory-information/search-fdaguidance-documents/deciding-when-submit-510kchange-existing-device.
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or accessories, and human factors of the
interface (see B5 of the same guidance,
‘‘Is it any other change in design (e.g.,
dimensions, performance specifications,
wireless communication, components or
accessories, or the patient/user
interface)?’’); and
those that significantly affect its use,
potentially necessitating clinical
validation data (see B5.1 and B5.3 of the
same guidance, ‘‘Does the change
significantly affect the use of the
device?’’ and ‘‘Are clinical data
necessary to evaluate safety or
effectiveness for purposes of design
validation?’’).
Each of those changes in this example
could require a 510(k), depending on
the specifics of the changes. In deciding
whether to submit a 510(k),
manufacturers may want to review the
guidance in its entirety since the
considerations for the example are not
exhaustive and may or may not be
applicable, depending on the specific
device. Manufacturers may also want to
review FDA’s guidance, ‘‘Deciding
When to Submit a 510(k) for a Software
Change to an Existing Device,’’ issued
October 25, 2017.2
Note that, although a wireless airconduction hearing aid classified under
§ 874.3305, or a legacy air-conduction
hearing aid classified under § 874.3300,
is exempt from requirements for
premarket notification, some changes
could exceed the limitations of
exemption under § 874.9 (21 CFR
874.9), depending on the specifics.
(Comment 6) Commenters requested
clear guidance on the specific
information manufacturers would need
to submit in a 510(k) to bring devices to
market quickly, avoiding unnecessary
delays or unnecessarily hindering
innovation.
(Response) In addition to the required
information specified in the 510(k)
procedures under 21 CFR part 807,
subpart E, the specific information that
a manufacturer should submit will vary
based on the new device or specific
changes made to an existing device.
Therefore, providing specific guidance
for all manufacturers in this final rule is
not feasible. However, FDA’s usual
policies on the content and format of
510(k)s apply to submissions for hearing
aids, including for modifications made
to satisfy applicable special controls and
the OTC Hearing Aid Controls.
Manufacturers may wish to review
publicly available information regarding
the De Novo classification of self-fitting
2 The
document is available online at: https://
www.fda.gov/regulatory-information/search-fdaguidance-documents/deciding-when-submit-510ksoftware-change-existing-device.
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air-conduction hearing aids. (See the
response to Comment 5 regarding when
to submit a 510(k).)
In the case of OTC hearing aids, we
anticipate that many manufacturers that
submit a 510(k) could avail themselves
of the Abbreviated 510(k) Program, as
described in FDA’s guidance of that
name, issued on September 13, 2019.3
Should a manufacturer incorporate selffitting (or other) technology into one of
its existing legacy or wireless devices
and need to submit a 510(k), we would
expect that the manufacturer could
leverage the similarity with exempt
devices as a least-burdensome way to
obtain marketing authorization for the
device that is not exempt from
premarket notification requirements.
Manufacturers of existing devices may
not need to re-address questions, for
example, related to electromagnetic
compatibility (EMC), provided the
manufacturer has not made changes that
would affect EMC and require a 510(k)
under our usual policies. Further,
summary reports describing how the
hearing aid complies with applicable
special controls may be especially
useful in addressing clinical data that
support the effectiveness of the selffitting strategy, usability testing, and
software verification, validation, and
hazard analysis.
Moreover, manufacturers that have
decided to submit a 510(k), whether
traditional or abbreviated, may wish to
review FDA’s guidance, ‘‘Format for
Traditional and Abbreviated 510(k)s,’’
issued on September 13, 2019.4 The
guidance provides a general framework
for the format and content of a 510(k).
(Comment 7) Commenters requested
that FDA exempt certain kinds of
hearing aids, including self-fitting
devices, from premarket notification
requirements. Some posited that FDA
would accrue sufficient experience with
self-fitting air-conduction hearing aids
to evaluate the potential for 510(k)
exemption 2 years after the effective
date of this final rule. Others requested
that FDA explain how OTC hearing aids
will become 510(k)-exempt.
(Response) FDA’s usual policies for
exempting devices from premarket
notification requirements apply to selffitting air-conduction hearing aids.
Stakeholders may wish to review FDA’s
guidance, ‘‘Procedures for Class II
Device Exemptions from Premarket
Notification,’’ issued February 19,
3 The document is available online at: https://
www.fda.gov/regulatory-information/search-fdaguidance-documents/abbreviated-510k-program.
4 The document is available online at: https://
www.fda.gov/regulatory-information/search-fdaguidance-documents/format-traditional-andabbreviated-510ks.
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1998.5 The guidance lists several factors
that FDA may consider for exemption,
including:
The history (if any) of false or misleading
claims or of risks associated with inherent
characteristics of the device, such as device
design or materials (FDA considers the risks
associated with false or misleading claims,
and the frequency, persistence, cause, or
seriousness of the inherent risks of the
device);
How characteristics of the device necessary
for its safe and effectiveness performance are
well established;
How changes in the device that could
affect safety or effectiveness will either be
readily detectable or not materially increase
the risk of injury, incorrect diagnosis, or
ineffective treatment;
How any changes to the device would not
be likely to result in a change in the device’s
classification; and
The role of the limitations of exemption.
Although the amount of time that has
passed since the classification of the
device in question may affect how FDA
views the factors, for example, the
history of false or misleading claims, the
amount of time since classification is
not generally directly relevant. That is,
2 years after the effective date of this
final rule may or may not afford
sufficient experience and information to
exempt all self-fitting air-conduction
hearing aids from premarket notification
requirements. We did not propose to
exempt self-fitting air-conduction
hearing aids and are not doing so now
(see 86 FR 58150 at 58171).
B. Scope (§ 800.30(a))
We received several comments on
which devices should be subject to the
OTC Hearing Aid Controls and,
conversely, which devices should be
prescription. Sometimes these
comments referred to definitions rather
than scope. In this section, we respond
to comments on scope, including
comments where the suggested changes
to the definitions affect the scope. The
next section of this document,
specifically for definitions, responds to
comments that relate more directly to
the clarity of terms or the usefulness of
different terms.
(Comment 8) Comments requested
clarification on the applicability of the
OTC Hearing Aid Controls in
circumstances in which software
intended for compensation for hearing
loss operates or adapts the output of
other hearing products such as earbuds
or headphones.
5 The document is available online at: https://
www.fda.gov/regulatory-information/search-fdaguidance-documents/procedures-class-ii-deviceexemptions-premarket-notification-guidanceindustry-and-cdrh-staff.
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(Response) To date, FDA has not
classified a device that adapts the
output of other hearing products, such
as earbuds, to compensate for perceived
mild to moderate hearing impairment,
including a device that accomplishes
this through software. Overall, FDA
encourages innovation of hearing
products that are safe and effective and,
to that end, intends to consider
developing guidance to provide
clarification on the applicability of laws
and regulations implemented by FDA in
circumstances where software would
operate or adapt the output of hearing
products to compensate for perceived
mild to moderate hearing impairment.
However, considering that in such
circumstances, the software might be
distributed separately from the hearing
product, FDA has added requirements
in the OTC Hearing Aid Controls for
software device labeling. Similar
requirements for software device
labeling were also added to § 801.422.
(See Additional Revision 3 in section
III.D.6 describing the labeling
requirements for hearing aid software.6)
The software device labeling
requirements take into consideration
certain aspects associated with software
not distributed with the hearing
product, including that such software
may not be provided in a package.
(Comment 9) A comment questioned
whether a software interface for
professionals such as audiologists or
hearing instrument specialists would
cause a hearing aid to be a prescription
device if the professional could adjust
the output in excess of the applicable
limit.
(Response) If a manufacturer markets
an OTC hearing aid that meets the OTC
hearing aid definition and complies
with all applicable requirements of the
OTC Hearing Aid Controls—but also
offers an additional separate feature, a
software interface for professionals that
allows only licensed persons to adjust
the device output—FDA likely would
not consider the hearing aid to be a
prescription device, but the software
interface for professionals would be a
prescription device and therefore must
comply with §§ 801.422 and 801.109.
(Note that a software interface for an airconduction hearing aid, which is the
subject of this response, would be
6 We refer to ‘‘additional revisions’’ to indicate
changes that FDA has made in further consideration
of comments and the issues involved in this
rulemaking, but that are additional to the
suggestions made explicitly in comments. We have
numbered the Additional Revisions in the order
that they appear in this document, which depends
upon the subject of the revision—definitions,
outside package labeling, etc.—not the order in
which the Additional Revisions are crossreferenced in our responses to comments.
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distinct from the hypothetical hearingaid software device, described in the
response to Comment 8, that operates or
adapts the output of other hearing
products such as earbuds or
headphones.)
However, the intended use of a device
can change after initial introduction into
interstate commerce (see § 801.4). If a
manufacturer intends prescription uses
of a device, the manufacturer should
consider how to ensure the device will
satisfy all applicable requirements, for
example, prescription labeling
requirements. Should a manufacturer
provide or allow users, and not just
licensed persons, ready access to an
interface that allows the user to
configure the device to provide output
in excess of that allowed for OTC
hearing aids, this would indicate the
device is intended for users (not limited
to licensed persons) to set an
excessively high output. FDA would be
more likely to determine that the
intended use was not for perceived mild
to moderate hearing impairment.
Additionally, such a device would not
meet the required output limits in the
OTC Hearing Aid Controls. Therefore,
such a device would be considered a
prescription hearing aid and must meet
applicable requirements, including
those under §§ 801.422 and 801.109;
otherwise, it would be in violation of
the FD&C Act.
(Comment 10) Some comments
suggested that FDA limit the scope of
the OTC Hearing Aid Controls to
devices intended only for people with
perceived mild, but not moderate,
hearing impairment. Some of these
comments suggested that perceived
moderate hearing impairment requires
the involvement of a licensed person for
successful treatment, and as such,
hearing aids intended for perceived
moderate hearing impairment should
not be available over the counter.
(Response) FDA disagrees that the
involvement of a licensed person is
necessary for hearing aids intended for
perceived moderate hearing
impairment. We are retaining perceived
moderate hearing impairment within
the scope of the OTC Hearing Aid
Controls. The question of whether the
involvement of a licensed person would
benefit an individual’s hearing
healthcare is separate from whether the
individual would benefit from the use of
an OTC hearing aid. In other
circumstances, the availability and use
of OTC medical products to treat an
illness or impairment does not imply
the illness or impairment is not serious.
Similarly, the availability and use of
OTC medical products does not negate
the benefit of a licensed person’s
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involvement. FDA considers the use of
OTC hearing aids, even when intended
for perceived moderate hearing
impairment, to be such a set of
circumstances.
Further, by statute, OTC hearing aids
include devices that are intended to
compensate for perceived moderate
hearing impairment, and such devices
are to be available to consumers over the
counter without the involvement of a
licensed person (see 21 U.S.C.
360j(q)(1)(A)(ii) and (v)). Section 709(b)
of FDARA requires FDA to issue
regulations that include, among other
requirements, provisions for reasonable
assurance of safety and effectiveness.
This rule will provide reasonable
assurance of safety and effectiveness,
without the involvement of a licensed
person, for OTC hearing aids, including
for hearing aids intended for perceived
moderate hearing impairment.
Thus, while the involvement of a
licensed person may benefit people with
perceived hearing impairment, whether
of a mild or moderate degree, FDA does
not agree that consumers must attempt
to obtain such a benefit prior to
purchasing hearing aids over the
counter. FDA is maintaining perceived
moderate hearing impairment within
the scope of the OTC Hearing Aid
Controls.
(Comment 11) Some comments
objected to the inclusion of ‘‘perceived’’
when referring to the kind of hearing
impairment for which OTC hearing aids
are intended. The commenters express
concern that a person’s perception of
hearing loss may be too subjective, and
that the use of OTC hearing aids should
be based on more objective measures.
Some of the comments suggested that
FDA require prospective users to obtain
audiograms, which are graphs or test
results showing the person’s ability to
hear different frequencies, from a
licensed person prior to purchasing an
OTC hearing aid.
Besides obtaining an audiogram, other
comments suggested a more general
testing or examination requirement by a
licensed person for prospective users,
prior to purchase. In this way, these
commenters suggested, OTC hearing aid
users would have more certainty that
OTC hearing aids would appropriately
compensate for their hearing
impairment, and/or the prospective user
does not have an underlying, medically
treatable cause of hearing impairment,
for example, one of the ‘‘red flag’’
conditions. (A ‘‘red flag’’ condition is a
sign or symptom that should prompt a
consultation with a doctor, preferably
an ear-nose-throat doctor.)
(Response) FDA disagrees. We are
retaining ‘‘perceived’’ in reference to a
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person’s degree of hearing impairment
and the intended use of OTC hearing
aids for legal and policy reasons. The
term ‘‘perceived’’ is used in section
520(q)(1)(A)(ii) of the FD&C Act to
describe the intended use for OTC
hearing aids. Moreover, objective
measurements of hearing impairment
are not necessary for reasonable
assurance of safety and effectiveness of
OTC hearing aids.
Relying on perceptions of hearing
impairment is also appropriate because
the type and degree of impairment exist
on a continuum, as does a person’s
perception and experience of the
impairment. A given degree
(quantification) of hearing impairment
will not necessarily reflect whether an
OTC hearing aid is likely to benefit a
specific individual. We have therefore
focused on communication and other
perceptual experiences (such as
listening to music) in which an
intended user is likely to suspect or
notice—that is, to perceive—hearing
impairment. FDA expects this approach
based on perception to assist users and
prospective users better than an
approach that does not.
Additionally, while FDA agrees that
an audiogram would provide a
prospective user with an objective
measure of hearing impairment, we do
not agree that the scope of the OTC
Hearing Aid Controls should include
only hearing aids for objectively
measured impairments. Such a
limitation is counter to the objectives of
section 709 of FDARA, including
making available hearing aids OTC,
without the involvement of a licensed
person, to consumers through in-person
transactions, by mail, or online.
We acknowledge that this places some
onus on users and prospective users.
However, this is the case with respect to
OTC availability of many medical
products, and we are establishing
requirements that will provide
reasonable assurance of safety and
effectiveness for such availability of
hearing aids. We also observe that,
while an audiogram might help a user
or a licensed person tailor the hearing
aid, or initially select it, even a hearing
health care provider would still ask the
user how the device sounds to the user.
The user’s perception would help the
hearing health care provider make
further adjustments. A person’s desire to
seek and use hearing aids depends more
directly upon that person’s perception
of their hearing impairment than the
definitive degree of impairment, and
even a licensed person fitting and
adjusting the device would also account
for the user’s perception. (See also the
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response to Comment 24 about defining
hearing loss numerically.)
Further, FDA has included
information in the labeling requirements
for OTC hearing aids intended to help
users understand whether the devices
are suitable based on their perceptions,
realistic expectations for hearing aid
use, and suggestions on when to obtain
professional assistance before and after
purchase. Should prospective OTC
hearing aid users still feel uncertain
about their perceptions of impairment,
notwithstanding the availability of the
aforementioned information, they may
choose to obtain or undergo professional
testing prior to purchase.
(Comment 12) Some commenters
suggested that FDA require a
prescription for OTC hearing aids.
(Response) FDA disagrees. Requiring
a prescription to purchase an OTC
hearing aid would be contrary to the
purposes of this rulemaking, the
definition of OTC hearing aids in the
FD&C Act, and FDARA which includes
the mandate to establish requirements
for hearing aids to be available over the
counter (see section 520(q)(1)(A)(v) of
the FD&C Act and section 709(b)(1) and
(b)(2)(D) of FDARA). It also would
negate the probable health benefits
created by wider availability of hearing
aids, as we described in the proposal
(see 86 FR 58150 at 58152).
(Comment 13) Multiple comments
suggested FDA remove dispensing from
the list of commercial activities that
FDA included in the definition of
‘‘licensed person.’’ The definition listed
commercial activities involving OTC
hearing aids for which a State or locality
could not require the involvement of a
licensed person. For example, a State
could not require a person representing
as a dispenser of OTC hearing aids to
undertake special licensing or
equivalent activities solely for that
reason.
Such comments cited various reasons,
for example, that State regulatory
regimes impose obligations on people
representing as dispensers, so referring
to the term in the OTC Hearing Aid
Controls would create an inconsistency
with State regulatory requirements.
Other comments pointed out that people
expect dispensers to have licenses, and
FDA’s regulations would be inconsistent
with such expectations. Still others
cited the need for dispensers to acquire
and/or demonstrate qualifications prior
to dispensing OTC hearing aids.
Similar comments suggested that FDA
instead refer to dispensers as ‘‘sellers,’’
‘‘vendors,’’ ‘‘merchants,’’ or other such
terms. These terms, the comments
assert, would distinguish salespeople
from hearing health care providers.
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(Response) FDA is not modifying the
scope of the OTC Hearing Aid Controls
or the definition of ‘‘licensed person’’ to
exclude dispensing of OTC Hearing
Aids. As we explained in the proposed
rule, FDARA lists certain activities that
may be undertaken with respect to OTC
hearing aids for which a State or locality
cannot require the involvement of a
licensed person (see 86 FR 58150 at
58158). One such activity that FDARA
explicitly lists is the dispensing of OTC
hearing aids. This means that, under
Federal law, a State or locality cannot
require a dispenser of OTC hearing aids
to undertake special licensing or
equivalent activities because that would
in essence require the involvement of a
licensed person, contrary to section
709(b)(2)(D) of FDARA and section
520(q)(1)(A)(v) of the FD&C Act.
Additionally, in establishing the OTC
category for hearing aids, we have
developed requirements to provide
reasonable assurance of safety and
effectiveness for OTC hearing aids
without the involvement of a licensed
person (see section 709(b)(2) of
FDARA). Imposing special licensing
requirements or equivalent activities,
therefore, is not necessary to provide
reasonable assurance of safety and
effectiveness of OTC hearing aids.
Although not required, a purchaser of
OTC hearing aids can still seek the
assistance of a licensed person when
selecting a hearing aid.
Since a person may dispense OTC
hearing aids without a specialized
license or the need to involve a licensed
person, referring to dispensers by
another term such as ‘‘vendor’’ or
‘‘seller’’ is not necessary to distinguish
dispensing from activities requiring
specialized licensure or the involvement
of a licensed person. Moreover, we have
previously defined dispensers as
persons engaged in the sale, lease, or
rental of hearing aids (see prior
§ 801.420(a)(3)). The regulations we are
finalizing in this rulemaking use
essentially the same definition. In sum,
using alternative titles for dispensers
may serve to confuse consumers by
unnecessarily establishing another term
for a legally permissible activity as well
as incorrectly implying that FDA’s
interpretation of the term has changed.
FDA recognizes that State and local
requirements sometimes incorporate the
term ‘‘dispenser,’’ and multiple States
impose requirements on account of
dispensing hearing aids. However,
FDARA section 709(b)(4), to summarize,
provides that no State or local
government shall continue in effect
certain State or local requirements that
are different from, in addition to, or
otherwise not identical to the
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regulations issued under FDARA
section 709(b). Thus, regardless of
whether a State or locality amends or
otherwise updates its requirements, it
may not continue in effect the
inconsistent requirements prior to their
amendment or repeal.
As we explained in the proposal,
despite the fact that licensure is not
required for dispensing OTC hearing
aids, some persons may voluntarily
identify as a ‘‘licensed dispenser,’’ (see
86 FR 58150 at 58168). Although a State
or locality could not require dispensers
(or other persons) to undertake special
licensing solely on account of
commercial activity involving OTC
hearing aids, a State or locality could
still establish licensure criteria that
would apply to those voluntarily
identifying as licensed persons. In such
a case, the dispenser’s identification as
a licensed person would imply that the
dispenser complies with applicable
State or local licensing requirements,
albeit voluntarily. (See also the
responses to Comment 15, discussing
other licensing considerations, and
Comment 127, discussing the
involvement of a licensed person for
prescription hearing aids.)
In sum, in light of Federal statutory
and other requirements, including those
that provide reasonable assurance of
safety and effectiveness of OTC hearing
aids, FDA is not narrowing the scope of
the OTC Hearing Aid Controls to
exclude dispensing. This does not,
however, prevent dispensers of OTC
hearing aids from voluntarily subjecting
themselves to State or local licensing
requirements to obtain a license (or its
equivalent).
(Comment 14) Comments suggested
that OTC hearing aids be available for
all degrees of hearing impairment,
including degrees greater than
moderate. Some of these comments
further noted that Medicare does not
currently pay for or reimburse the cost
of hearing aids. As such, the comments
asserted that OTC hearing aids should
be usable as lower-cost alternatives to
prescription hearing aids for individuals
with more-profound impairments.
(Response) For the reasons explained
in the response to Comment 10, FDA is
establishing requirements for perceived
mild to moderate hearing impairment.
Thus, the appropriate device output
limit that we are establishing would not
extend to hearing impairment that
would require a greater output than that
which is appropriate for perceived
moderate hearing impairment.
However, devices of the same type
may generally be intended either for
prescription or OTC use. For example,
a manufacturer marketing an OTC
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wireless hearing aid could also market
another wireless hearing aid with a
higher output than that permitted for
OTC hearing aids. This higher output
would render it a prescription device.
As with other products that have
differing uses but share manufacturing
similarities, a hearing aid manufacturer
may be able to realize economies of
scale by selling an OTC version and a
prescription version of hearing aids that
fall within the same type, which in turn
could lower the prices for prescription
hearing aids. (See also the response to
Comment 17 about limitations on FDA’s
authority to require reimbursement for
devices.)
(Comment 15) Some comments
suggested FDA define which activities
involving hearing aids would require
licensure.
(Response) FDA does not generally
determine which activities involving
medical products require licensure.
However, section 709(b)(4) of FDARA
lists several activities for which States
or localities may not require specialized
licensure for, or the involvement of a
licensed person in, commercial activity
involving OTC hearing aids. These
listed activities are the servicing,
marketing, sale, dispensing, use,
customer support, or distribution of
OTC hearing aids through in-person
transactions, by mail, or online. As we
explained in the proposal, we interpret
the listed activities broadly, so for
example, the term ‘‘sale’’ would include
leases or rentals (see 86 FR 58150 at
58165).
States usually determine the
requirements for licensure or the
involvement of licensed persons. States
may still do so with respect to hearing
aids when not prohibited by section
709(b)(4) of FDARA (and other
applicable laws). Where section
709(b)(4) of FDARA does not list an
activity, when construing the terms
broadly, a State may require licensure
for that activity as it relates to OTC
hearing aids. We note that the proposal
provided a discussion and some
examples (see 86 FR 58150 at 58167–
58168). Thus, for example, a State may
require a license for a hearing aid fitter,
because ‘‘fitting’’ is not listed among the
activities in section 709(b)(4) of FDARA,
and we do not interpret any of the listed
activities to include fitting. A person
could not be a fitter in that State, even
for OTC hearing aids, without a license.
However, the State could not require a
hearing aid fitting prior to a user
purchasing an OTC hearing aid because
that would restrict or interfere with
commercial activity involving OTC
hearing aids. See the response to
Comment 13 for further explanation.
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Thus, a State may still establish
criteria for licensing dispensers should
a person voluntarily decide to become a
licensed dispenser of OTC hearing aids.
In other words, although a State cannot
require a license for dispensing OTC
hearing aids, a State can establish what
a person must do to obtain, and claim
to have, a license for dispensing hearing
aids. FDA expects that States may wish
to continue in effect licensing
requirements to dispense prescription
hearing aids, and we expect that some
hearing aid dispensers may wish to
obtain a license in the event they desire
to advertise as ‘‘licensed’’ and/or to sell
prescription hearing aids in addition to
OTC hearing aids.
(Comment 16) Some comments urged
FDA to limit the scope of OTC
availability as much as possible, at least
in the beginning. These comments
conveyed concerns for the absence of a
licensed person in various roles,
including education and counseling.
One such comment suggested that a
more-limited scope would be easier to
broaden later than the reverse, limiting
a broader scope.
(Response) In the proposed rule, we
explained that several barriers likely
impede people’s access to hearing aids,
including among others, Federal and
State regulatory requirements (see 86 FR
58150 at 58152, 58154). We are
undertaking this rulemaking in part to
remove or reduce such barriers to access
by establishing requirements that will
provide reasonable assurance of safety
and effectiveness while encouraging
broad availability (see 86 FR 58150 at
58158). Moreover, we received a wealth
of thoughtful and nuanced comments
about the scope of the OTC Hearing Aid
Controls, including this Comment, and
we have determined that a morerestrictive approach is not necessary for
reasonable assurance of safety and
effectiveness of OTC hearing aids.
Considering our purpose to broaden
access and our determinations regarding
reasonable assurance of safety and
effectiveness, we do not agree that
narrowing the scope of the OTC Hearing
Aid Controls, with the intention of
considering a broader scope later, is
currently an appropriate strategy.
(Comment 17) Some comments noted
the role of health insurers, including
Medicare, in a person’s ability to obtain
hearing aids. Comments suggested that
FDA focus on payments or
reimbursements for hearing aids,
potentially including financial
incentives.
(Response) FDA does not have
authority to require payors to pay for or
reimburse the cost of hearing aids or to
offer financial incentives to obtain the
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devices. However, we intend this rule,
among other ends, to broaden access to
hearing aids by eliminating certain
kinds of requirements that likely add to
the cost of accessing the devices. For
example, we are establishing rules to
make OTC hearing aids available
without the involvement of a licensed
person.
C. Definitions (§§ 800.30(b) and
801.422(b))
This section focuses on explaining the
final definitions. Generally, commenters
sought clarity, and we have generally
accepted or declined suggestions with
the goal of improving clarity of the
definitions.
(Comment 18) Multiple comments
proposed that FDA use another name to
identify OTC hearing aids. For example,
some comments proposed ‘‘over-thecounter hearing device,’’ ‘‘self-fit overthe-counter hearing device,’’ ‘‘hearing
amplifiers,’’ and ‘‘hearing devices.’’
Generally, these commenters sought to
avoid confusion with existing devices
for both consumers and State regulators.
Otherwise, commenters believed,
consumers may be misled into believing
that OTC hearing aids are equivalent to
prescription hearing aids with respect to
performance, safety, and effectiveness,
and there may be regulatory issues for
State licensing boards. Other comments
argued that the availability of OTC
devices through retailers such as grocery
or department stores would suggest that
these devices are not hearing aids, so
referring to them as such would be
inappropriate.
By identifying OTC hearing aids in a
different way, consumers, regulators,
and other stakeholders would, the
comments argued, have a clearer
indication of devices subject to the new
regulatory category. Many such
comments noted that the use of a term
other than ‘‘hearing aid’’ was
recommended by the National
Academies of Sciences, Engineering,
and Medicine (NASEM) in their report,
‘‘Hearing Health Care for Adults:
Priorities for Improving Access and
Affordability,’’ and by the Hearing Care
Associations in their Consensus Paper,
‘‘Regulatory Recommendations for OTC
Hearing Aids: Safety & Effectiveness’’
(Ref. 7).
(Response) FDA will continue to use
the term ‘‘hearing aids’’ to refer to the
OTC and prescription devices subject to
this rulemaking because the use of this
term is appropriate. Hearing aids,
whether OTC or prescription, are
wearable sound-amplifying devices
intended to compensate for impaired
hearing. The term ‘‘hearing aid’’
describes several device types reflected
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in various classification regulations.
Although OTC hearing aids use airconduction technology, prescription
hearing aids may do so as well (for
example, an air-conduction hearing aid
that provides a higher output than that
specified in the OTC Hearing Aid
Controls would be prescription).
Therefore, the use of the term ‘‘hearing
aid’’ is appropriate to reflect both OTC
and prescription devices that fall within
the same device type (for example,
wireless air-conduction hearing aids
under § 874.3305). Moreover, section
520(q)(1)(A) of the FD&C Act explicitly
uses and defines the term ‘‘over-thecounter hearing aid[s],’’ and section
709(b)(1) of FDARA requires the
establishment of ‘‘a category of over-thecounter hearing aids.’’ Thus, referring to
the devices by a different name would
not only be inconsistent with the
applicable classification regulations and
statutes, but also FDA expects that
doing so would cause confusion and
uncertainty for consumers considering
purchasing an OTC hearing aid.
Further, we expect this rulemaking to
broaden the kinds of retailers that sell
OTC hearing aids, helping to increase
the availability of the devices. By
extension, the availability of OTC
hearing aids (by that name) in grocery
and department stores would help fulfill
one of the purposes of this final rule.
Moreover, many technologically similar
products are available and go by several
names, including ‘‘personal amplifier.’’
Based on their intended use(s), some of
these may not be devices and/or meet
applicable requirements for devices, yet
they may appear to some prospective
purchasers to be suitable alternatives to
safe and effective devices.7 We expect
that consumers are familiar with the
name ‘‘hearing aid,’’ and using that
name will better support broadened use
of the devices. At the same time, we
expect that introducing yet another
name for a similar technology, albeit
regulated as a device, would only serve
to increase confusion in the marketplace
because prospective purchasers may
think that a hearing aid could be
marketed under other names, including
those used for products that do not meet
applicable device requirements. Thus,
we have determined that the best way
to indicate whether the device is subject
to this rulemaking is to use the name
‘‘hearing aid’’ as used for the device
types in the applicable classification
7 FDA is finalizing a guidance alongside this
rulemaking to help stakeholders distinguish hearing
aids from PSAPs. To summarize, a PSAP is an
electronic product intended for non-hearingimpaired people to amplify sounds in certain
environments. A PSAP is not intended to aid with
or compensate for impaired hearing.
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regulations, and the name that is
established in the FD&C Act and
FDARA, OTC hearing aids.
To assist consumers further, as well as
ease determining the applicability of the
OTC Hearing Aid Controls, we are
modifying the labeling and conditions
for sale for OTC hearing aids. See
Additional Revisions 2 (section III.D.3)
and 4 (section III.G), respectively, for
further explanation.
Although the technical specifications
are different for OTC hearing aids and
prescription hearing aids, as explained
elsewhere in this document, FDA
believes the technical specifications for
each category are appropriate.
Additionally, information on the
technical specifications is required to be
provided in the device labeling. FDA
believes that OTC hearing aids that
comply with § 800.30 and other
applicable requirements (for example,
Quality System requirements) will have
reasonable assurance of safety and
effectiveness for people aged 18 and
older with perceived mild to moderate
hearing impairment.
(Comment 19) A comment suggested
that the definition of ‘‘hearing aid’’
should include an explicit statement
that PSAPs are not hearing aids. The
comment mentioned the draft guidance
we are finalizing concurrently with this
final rule, ‘‘Regulatory Requirements for
Hearing Aid Devices and Personal
Sound Amplification Products,’’ which
is published elsewhere in this issue of
the Federal Register and is also
available at: https://www.fda.gov/
regulatory-information/search-fdaguidance-documents/regulatoryrequirements-hearing-aid-devices-andpersonal-sound-amplification-products,
and characterized the draft of the
guidance as ‘‘provid[ing] essential
distinctions between [hearing aids] and
PSAPs.’’
(Response) FDA agrees that
distinguishing between hearing aids
(devices) and PSAPs (non-devices) can
be an important interest for purchasers,
manufacturers, and other stakeholders.
We are finalizing requirements for the
principal display panel on the package
of an OTC hearing aid to bear the marks
‘‘OTC’’ and ‘‘hearing aid’’ (see
Additional Revision 2 in section III.D.3).
We are also finalizing a corresponding
condition for sale that sellers may only
make a hearing aid available OTC when
its package bears the requisite marks
(see Additional Revision 4 in section
III.G). Moreover, we are finalizing the
aforementioned draft guidance
document, intended to describe hearing
aids, PSAPs, their respective intended
uses, and the regulatory requirements
that apply to both types of products.
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We are not, however, modifying the
definition of ‘‘hearing aid’’ to state that
PSAPs are not hearing aids. As we
explained in the proposed rule, the
name of a product on its own would not
ordinarily demonstrate intended use (86
FR 58150 at 58154). Thus, merely
excluding PSAPs from the definition of
hearing aid does not remove a product
from device regulation under the FD&C
Act if, for example, its labeling
demonstrated that the product was
intended to compensate for hearing loss.
We think the actions we are taking will
better assist stakeholders to distinguish
between products than modifying the
definition of ‘‘hearing aid’’ in the OTC
Hearing Aid Controls.
(Comment 20) Some comments
suggested adding definitions to the
classification regulation for self-fitting
hearing aids (§ 874.3325). For example,
comments suggested FDA define
‘‘programming the hearing aid’’ and
‘‘self-fitting strategy.’’
(Response) FDA is not adding
definitions for purposes of the selffitting air-conduction hearing aid
classification at this time. In considering
possible definitions to add, including
those suggested in the comments, we
sought to balance clarity with flexibility.
The phrasing of § 874.3325(a) is
intended to cover a range of
technologies, both present and future,
without unduly constraining
innovation. For example, the regulation
refers to a ‘‘self-fitting strategy,’’ rather
than a more prescriptive description.
Under this regulation, manufacturers
could choose different strategies to
achieve self-fitting by the user while
still being substantially equivalent to
other devices of the same type. After
considering the comments, we have
decided not to constrain the
classification further.
However, we recognize that these
commenters desired to clarify the
classification of different types of airconduction hearing aids, including the
applicability of special controls and
premarket notification requirements. We
have provided our thinking and
expectations in section V.A. of this
document to address such concerns.
Further, FDA may issue guidance on
this subject in the future following our
Good Guidance Practices and inviting
additional comments (see 21 CFR
10.115).
(Comment 21) Several comments
requested that FDA define self-fitting
hearing aids in such a way as to clarify
that the devices must be manipulable by
the general public. Many of these
comments showed concern about
predatory business practices, through
which manufacturers might prevent
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users from customizing device output,
because they did not view self-fitting
capability as clearly required for OTC
hearing aids.
(Response) FDA agrees that OTC
hearing aids must be somehow
manipulable by lay users; however, we
are not adopting these suggestions.
As explained in the response to
Comment 1, not all OTC hearing aids
are self-fitting devices classified under
§ 874.3325. Thus, FDA declines to
define self-fitting hearing aids in the
way suggested by comments.
Further, modifying the self-fitting
hearing aid classification regulation in
the suggested way is not necessary. By
definition, self-fitting air-conduction
hearing aids allow users to program
their hearing aids, and the devices
integrate user input with a self-fitting
strategy and enable users to
independently derive and customize
their hearing aid fitting and settings.
Should users themselves be unable to
derive or customize the fitting and
settings independently, or program their
hearing aids, FDA likely would not
consider it a self-fitting air-conduction
hearing aid.
More generally, section
520(q)(1)(A)(iii) the FD&C Act defines
an OTC hearing aid, in part, as a device
that allows the user to control the
hearing aid and customize it to the
user’s hearing needs. Should users of a
hearing aid be unable to control and
customize the device in the manner
required, the hearing aid would not be
an OTC hearing aid as defined in the
FD&C Act or final § 800.30, and thus,
would be a prescription device.
FDA also notes that the FD&C Act, the
OTC Hearing Aid Controls, and the
classification regulation for self-fitting
air-conduction hearing aids all refer to
the ‘‘user’’ of the hearing aid. Referring
to manipulation by the general public
may not accurately or adequately
represent the intended user(s) of a
hearing aid because the intended user(s)
may differ in significant ways from the
general population. However, FDA
agrees that manufacturers should
generally assume that users are
laypeople (not experts) regarding OTC
hearing aids, and we are finalizing the
definition of ‘‘tools, tests, or software’’
as proposed. The definition specifically
requires that a lay user be able to control
and customize an OTC hearing aid.
Further, because OTC hearing aids are
not prescription devices (and are not
otherwise exempt from certain labeling
requirements), the labeling must include
adequate directions for use, which are
directions under which a layperson can
use the device safely and for its
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intended use(s) (see § 801.5 (21 CFR
801.5)).
(Comment 22) A comment suggested
that FDA explicitly require that users
have control of the device output to
customize the device to their hearing
needs. This comment argued the
phrasing of the definition for ‘‘tools,
tests, or software’’ that FDA proposed is
ambiguous, potentially allowing
manufacturers to restrict control of the
device to physical fit but not the sound
output.
(Response) As explained in the
response to Comment 21, section
520(q)(1)(A)(iii) of the FD&C Act defines
an OTC hearing aid as a device that,
through tools, tests, or software, allows
the user to control the hearing aid and
customize it to the user’s hearing needs.
In final § 800.30(b), we define ‘‘tools,
tests, or software’’ as components that
allow lay users to control the device and
customize the device sufficiently. As
explained in the response to Comment
1, we interpret the requirement for
customization to hearing needs to mean
that the device must allow the user to
cause frequency-dependent changes
based on the user’s preference, and the
requirement for user control to mean
that the user can access or select the
output characteristics most significant
to the user’s hearing perception. These
elements sufficiently describe the
requisite controllability and
customization without unnecessarily
constraining future technologies that
could be available OTC. We are not
modifying the OTC Hearing Aid
Controls as suggested. However, as
explained elsewhere in this document,
we added a user-adjustable volume
control to the design requirements for
OTC hearing aids so users will be able
to control this aspect of the sound
output.
(Comment 23) Comments suggested
that FDA include in the definition of
‘‘used hearing aid’’ a stipulation that a
bona fide hearing aid evaluation extend
through a trial period that might last as
long as 90 days. That is, a device would
not be considered a ‘‘used hearing aid’’
solely because a prospective purchaser
wore it for an extended trial period,
without the presence of the dispenser or
a hearing health professional selected by
the dispenser.
(Response) FDA is not adopting this
suggestion because purchasers should
be aware of use of the device outside of
observation to ensure appropriate
operating conditions. This is because a
device will be in contact with the
ultimate user’s skin for extended
periods, and the device contains
sensitive electronics. Without
observation, a device that a prospective
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user is evaluating may be used in a way
that would make the device unsanitary
for the ultimate user, or the device
could have been subjected to damaging
conditions.
However, we are revising the
definitions and labeling requirements to
clarify labeling terms to convey
information better. If a manufacturer
inspects and tests a used hearing aid,
makes any necessary modifications to
the hearing aid to ensure it satisfies
applicable requirements to be available
OTC, including for labeling,
electroacoustic performance, and
design, and the manufacturer has
adequately reprocessed the hearing aid
for the next user, then the manufacturer
may describe the device as ‘‘rebuilt’’ in
the required labeling rather than
‘‘used.’’
(Comment 24) Multiple comments
proposed that FDA define mild to
moderate hearing impairment in terms
of objective criteria. For example, these
comments suggested that FDA adopt
thresholds used by the American
Speech-Language-Hearing Association
(ASHA) or the World Health
Organization (WHO) to categorize
hearing impairment. Others suggested
more generally that labeling describe
hearing impairment in detail so that
prospective OTC hearing aid users
would ‘‘understand exactly’’ their
degree of hearing impairment.
(Response) FDA is declining to define
hearing impairment for purposes of the
OTC Hearing Aid Controls in terms of
objective measurements because
defining hearing impairment in such a
way is neither necessary for, nor
consistent with, establishing an OTC
category of hearing aids.
Inconsistency would arise because the
requirements to establish the OTC
category focus on the hearing aid user’s
perception as well as making devices
available without the involvement of a
licensed person. Specifically, section
520(q)(1)(A)(ii) of the FD&C Act refers to
‘‘perceived’’ impairment in defining the
intended use of OTC hearing aids. As
explained in the response to Comment
11, the subjective nature of hearing
impairment is integral to the regulatory
category we must establish for OTC
hearing aids.
Further, an objective definition based
on measurement of hearing impairment
would imply the need to involve a
licensed person, such as an audiologist
or hearing instrument specialist, to
administer a test or otherwise provide
an exact understanding. However, OTC
hearing aids must be available without
the involvement of a licensed person
(see 21 U.S.C. 360j(q)(1)(A)(v)), and FDA
has determined that an objective
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measurement of hearing impairment is
not necessary for reasonable assurance
of safety and effectiveness of OTC
hearing aids. Thus, defining the degrees
of impairment in objective terms, using
one of several available schemes for
categorization, would be contrary to the
purposes of this final rule as well as
unnecessary.
We acknowledge that many licensed
persons use audiometric thresholdbased hearing loss categories to describe
hearing loss severity, and this
information may be useful to OTC
hearing aid users should they choose to
seek it out. However, the perception of
hearing difficulties is on a continuum
that is not confined to specific
audiometric threshold categories. For
example, two people with the same
audiometric thresholds may have
different subjective perceptions of, and
different personal preferences for
addressing, the impairment. The
intended user population will have a
broad range of perceptual difficulties
and communicative function because of
the wide variability and overlap in
perception of hearing impairment
within and across hearing loss severity.
The ASHA and WHO hearing loss
categories each reflect a continuum
while providing high-level clinical
guidance. These categories do not
represent discrete perceptual
boundaries for the patient or for the
treating professional. Furthermore, these
hearing loss categories were not
formulated to determine regulatory
questions such as whether an individual
should have access to OTC hearing aids.
We are declining to adapt and apply
such a scheme in that way.
Nonetheless, we are establishing
labeling requirements to help
consumers recognize perceived mild to
moderate hearing impairment. See the
response to Comment 35 for more on
this topic. Further, the labeling
encourages users and prospective users
to seek professional services in several
circumstances, and people who wish to
measure their degree of hearing
impairment objectively or definitively
may still obtain such measurements
voluntarily.
(Comment 25) One comment
suggested that the definition of
‘‘prescription hearing aid’’ be revised to
further state that these devices are
dispensed by a State-licensed
professional.
(Response) FDA declines to revise the
definition of ‘‘prescription hearing aid’’
as suggested because it is unnecessary.
Prescription hearing aids are
prescription devices and as such, they
are subject to § 801.109. Under
§ 801.109(a), a prescription device is a
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device that is: (1) either in the
possession of a person, or his agents or
employees, regularly and lawfully
engaged in the manufacture,
transportation, storage, or wholesale or
retail distribution of such device or in
the possession of a practitioner, such as
physicians, dentists, and veterinarians,
licensed by law to use or order the use
of such device and (2) is to be sold only
to or on the prescription or other order
of such practitioner for use in the course
of his professional practice. Because
prescription hearing aids are required to
be in the possession of persons lawfully
engaged in the retail distribution (or
certain other activities) of such devices,
and must be sold only to or on the
prescription or other order of a licensed
practitioner, the revision suggested in
the comment is unnecessary.
(Additional Revision 1) After further
consideration, FDA is modifying the
definition of ‘‘dispenser’’ for the
purposes of prescription hearing aids
under final § 801.422(b). FDA proposed
that the term refer to any person
engaged in the sale of prescription
hearing aids. However, we observed a
potential for confusion based on
comments we received, because a
person engaged in the sale of OTC
hearing aids would also be a dispenser.
Thus, while the definition of the term in
§ 801.422(b) is for the purposes of
prescription hearing aid labeling, the
definition as proposed may have
appeared to create an inconsistency
with the use of the term outside of
§ 801.422. To avoid the potential
inconsistency and confusion, we are
removing ‘‘prescription’’ from the final
definition of ‘‘dispenser.’’
D. Labeling (§ 800.30(c))
FDA received many comments related
to labeling for OTC hearing aids. Most
of these comments focused on ensuring
the information would be easy to
understand for most people, that is,
people who are not professionals in a
field related to hearing impairment.
Commenters suggested various means to
improve the labeling, including
different phrasing, formatting, or
positioning. Others provided general
feedback and emphasized Plain
Language principles, and a need to
avoid jargon or overly technical
phrasing, to help readers understand
information in the labeling. FDA agrees
that Plain Language principles apply in
the case of labeling for hearing aid
users, and that Plain Language will help
users to understand the information in
the device labeling.
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1. User-Friendly Labeling
(Comment 26) Some comments
expressed concern that FDA did not
validate the labeling of the OTC hearing
aids. Many of these comments are
concerned that without labeling
validation, a consumer’s ability to selfdiagnose their hearing loss will be
hindered. These comments suggested
that a requirement for manufacturers to
validate labeling will help to ensure that
users can properly self-diagnose their
hearing loss.
(Response) FDA is declining to adopt
labeling validation requirements for
OTC hearing aids at this time. The
labeling requirements we are finalizing
benefitted from extensive input from
many sources, including docket
comments and public workshops, such
as the one convened by NASEM.
Additionally, self-fitting air-conduction
hearings aids under § 874.3325 are
subject to a special control requiring
usability testing, which inherently
includes testing the directions for use by
the user. Further, any device must have
labeling bearing adequate directions for
use unless subject to an exemption (see
section 502(f)(1) of the FD&C Act and
§ 801.5). This means that the directions
for use for an OTC hearing aid must
allow a lay user to use the device safely
and for its intended purposes (see
§ 801.5). Given these requirements, and
the extensive input we have received for
labeling, a requirement for additional
validation is not needed for reasonable
assurance of safety and effectiveness.
(Comment 27) Multiple comments
proposed that labeling refer to an ‘‘EarNose-Throat Doctor,’’ ‘‘ENT,’’ or similar
terms instead of referring to an ‘‘ear
specialist.’’ These comments suggested
that ‘‘ear specialist’’ is not specific
enough because it might imply
somebody besides a physician. For
example, it could refer to an audiologist
or a hearing aid dispenser, neither of
whom need be a physician. As such,
‘‘ear specialist’’ may confuse or
inadvertently mislead hearing aid users.
(Response) FDA agrees that ‘‘ear-nosethroat doctor’’ and ‘‘ENT’’ are more
descriptive and likely more common
than ‘‘ear specialist.’’ We have revised
labeling throughout to adopt this
suggestion when referring to physicians.
(Comment 28) A comment suggested
that labeling refer to ‘‘physicians’’ rather
than ‘‘doctors’’ because people who are
not physicians may be doctors, for
example, people who hold Ph.D.s
(philosophical doctors) or chiropractors
(some of whom are doctors of
chiropractic).
(Response) We are not adopting this
suggestion. We are adopting suggestions
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to refer to ‘‘ear-nose-throat doctors’’
instead of ‘‘ear specialists’’ to provide
better guidance to people who may be
unfamiliar with hearing healthcare
delivery (see the response to Comment
27). However, we do not expect that
people will seek the assistance of
philosophical doctors or chiropractors
for their hearing needs just because the
labeling for OTC hearing aids refers to
a ‘‘doctor’’ rather than a ‘‘physician.’’
Instead, we expect people who seek the
assistance of a doctor for their hearing
needs will exercise reasonable judgment
in discerning which kind of doctor
might help them with their hearing
needs, in the same way they might
exercise reasonable judgment to find
appropriate providers when suggested
by OTC labeling for other health
concerns.
(Comment 29) A comment requested
that ‘‘doctor’’ and ‘‘physician’’ in the
labeling be revised to ‘‘licensed
healthcare practitioner.’’ The comment
argued that use of ‘‘licensed healthcare
practitioner’’ is consistent with FDARA
and would ensure that patients see
qualified individuals, yet not confuse
and limit consumers about whom they
can consult.
(Response) FDA is declining to
replace all references to ‘‘doctor’’ or
‘‘physician’’ with ‘‘licensed healthcare
practitioner’’ because there are certain
aspects of hearing care where it is
warranted that a patient consult a
‘‘doctor.’’ As discussed in the response
to Comment 27, FDA is updating the
term ‘‘ear specialist’’ to ‘‘ear-nose-throat
doctor (ENT)’’ to avoid confusion as to
whom a consumer should consult.
Where FDA now uses the term ‘‘ENT’’
it is to clarify who is best positioned for
a patient to consult on a particular
matter. For example, an ENT would
generally be the kind of provider who
has the necessary qualifications and
expertise to conduct an examination for
the diagnosis of Red Flag conditions.
We acknowledge, however, that not all
hearing healthcare providers need to be
physicians and there are many
situations, such as consumers
continuing to have difficulty hearing
even after beginning use of OTC hearing
aids, where consulting licensed
healthcare providers would be
necessary or appropriate.
(Comment 30) A few comments
recommended rewording the ‘‘red flag’’
condition warnings to present the issue
first and then the solution. Comments
suggested the warning should be
updated to read, ‘‘[p]rior to purchasing
this device, if you have any of the
following you should promptly consult
with a licensed physician, preferably, an
Ear-Nose-Throat (ENT) doctor.’’
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(Response) FDA agrees that a different
presentation would more effectively
communicate the warning. In response
to comments proposing rewording to
increase readability, we have retitled the
warning and reordered the introduction
in the manner suggested and adopted
slightly different phrasing that we think
will be more user-friendly.
(Comment 31) A comment expressed
concern about the caution that hearing
aids are not hearing protection. Some
comments argued that it is
impracticable for hearing aid users to
take out their hearing aids in situations
where a loud sound is passing by.
Comments recommended the caution be
updated to advise individuals to mute
or turn off their hearing aids when
experiencing a loud sound and only
recommend removal of hearing aids if
the hearing aid does not provide any
hearing protection.
(Response) FDA is declining to
implement this revision. FDA has
included information in the labeling
requirements to help users have realistic
expectations when using hearing aids.
This particular caution is intended to
assist users in the day-to-day use of
their hearing aid and to notify them that
they should not rely on their hearing aid
for hearing protection. Additionally, the
labeling includes a caution that
individuals should turn down the
volume or remove the device if the
sound is uncomfortably loud or painful.
These two cautions provide appropriate
guidance to help ensure safety when
experiencing a loud sound.
(Comment 32) A few comments
requested revisions to the note regarding
expectations about what a hearing aid
can do to use more positive framing.
Comments argued that the note was
more a notice of what hearing aids
cannot do, and a more positive framing
would increase readability and product
desirability.
(Response) FDA agrees that it is
important for users to read and
understand the labeling easily, and we
have updated the note to include
language about the benefits as well as
limitations of OTC hearing aids. The
language was further updated to provide
notice that users may need to wait a few
weeks to get used to their hearing aids.
(Comment 33) A few comments
requested that FDA require a minimum
font size so that consumers can read and
understand the particulars of each OTC
hearing aid. Comments recommended
requiring font sizes from 12–14 points.
(Response) FDA is declining to
implement this suggestion. This rule
applies to a large number of
manufacturers and their various hearing
aids so FDA believes some flexibility is
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warranted. Additionally, we do not
believe a minimum font size is
necessary to ensure users can read and
understand the labeling for OTC hearing
aids because there are requirements that
address this. For example, under section
502(c) of the FD&C Act, a device is
misbranded if any word, statement, or
other information required by or under
authority of the FD&C Act to appear on
the label or labeling is not prominently
placed thereon with such
conspicuousness and in such terms as to
render it likely to be read and
understood by the ordinary individual
under customary conditions of purchase
and use (see 21 U.S.C. 352(c)). Given
this and other requirements, and the
need for some flexibility as the rule
applies to a variety of devices, FDA does
not believe a minimum font size is
warranted.
(Comment 34) A few comments
recommended that the descriptions of
functions of the hearing aids include
figures and videos alongside text to
provide additional clarity on how to use
hearing aids.
(Response) To help users after
purchase, the inside labeling must
include, among other information, a
description of accessories; illustration(s)
of the OTC hearing aid that indicates
operating controls, user adjustments,
and battery compartment; adequate
directions for use; technical
specifications; and a description of
commonly occurring, avoidable events
that could adversely affect or damage
the OTC hearing aid. The labeling
requirements will allow a lay user to use
the device safely and for its intended
purposes (see § 801.5). The additions
suggested by comments are not
necessary for reasonable assurance of
safety and effectiveness.
2. User Education
(Comment 35) A comment suggested
that device package labeling describe
hearing impairment in terms of common
perceptual difficulties. In specific, it
proposed that labeling describe mild
impairment as having difficulty hearing
soft-spoken people and young children.
According to the comment, people with
mild impairment are often able to hear
loud or more-intense vowel sounds but
may miss some of the softer consonant
sounds. Thus, they may have to ask
people to speak up or repeat themselves
on occasion. The comment further
stated that for someone with typical
hearing, this is comparable to placing a
finger in one’s ears.
The comment proposed that labeling
describe moderate impairment as having
additional difficulty hearing vowel
sounds in addition to missing consonant
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sounds. According to the comment, this
means that when someone is speaking at
a normal volume, a person with
moderate hearing impairment is unable
to hear most of the speech sounds.
Accordingly, people with moderate
hearing impairment often comment that
they hear sounds but cannot always
understand speech.
(Response) To help users determine
whether they have perceived mild to
moderate hearing impairment, FDA has
revised the package labeling
requirements by simplifying the
language and making it less formal. (See
the response to Comment 41 for more
about these revisions.) However, while
we agree that the suggested descriptions
may also be useful for prospective users,
other factors impact determining the
labeling requirements. These factors
include, for example, the limited space
available for the outside package
labeling, as many comments
emphasized, and whether the
information is necessary to provide
reasonable assurance of safety and
effectiveness. The descriptions
suggested in the comment would add to
the length of the material on the outside
packaging for OTC hearing aids.
Additionally, the required information
under final § 800.30(c)(1)(B) sufficiently
helps to provide reasonable assurance of
safety and effectiveness, without the
addition of the suggested text, because
it contains enough information for
someone to identify whether an OTC
hearing aid may be intended for their
particular hearing impairment.
Therefore, we are not revising this final
rule in the way suggested by the
comment.
However, as stated above, the
additional information described in the
comment may still be useful so we
intend to add similar information to
FDA’s website, which has pages focused
on hearing aids and hearing loss. You
can access the main web page at:
https://www.fda.gov/medical-devices/
consumer-products/hearing-aids. You
may also wish to review information
from the National Institute on Deafness
and Other Communication Disorders.
You can access their web pages at:
https://www.nidcd.nih.gov/health/
hearing-ear-infections-deafness. These
websites provide more information for
people interested in learning about
hearing aids and hearing loss.
(Comment 36) A few comments
expressed concern that, without proper
warnings on the label, purchasers would
not be informed on the limitations of
OTC hearing aids with regard to their
degree of hearing impairment.
(Response) FDA agrees and is
finalizing the clear statement that we
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proposed, with an updated, more userfriendly list of common symptoms of
mild to moderate hearing impairment.
We are also finalizing the requirement,
with similarly improved language, that
the labeling describe signs of more
severe impairment.
(Comment 37) A few comments
expressed concern about the statement
that hearing aids will not restore normal
hearing and that training and counseling
from a hearing healthcare professional
may increase satisfaction. Comments
argued that these ideas are based upon
current limitations of hearing aids and
recommended the statement be removed
because, they argued, future hearing
aids may have the capability to restore
hearing to a normal level.
(Response) FDA is declining to
remove this statement. The note informs
consumers of the limitations and
benefits they should expect from an
OTC hearing aid. Since many
purchasers will be selecting and using
OTC hearing aids without the
involvement of a licensed person, FDA
has included statements, including the
one discussed above, to help consumers
have realistic expectations about OTC
hearing aids. This helps provide
reasonable assurance of safety and
effectiveness.
(Comment 38) A few comments
requested that labeling include a
warning of when to stop use of OTC
hearings aids. The comments expressed
concerns that some hearing aid users
may be unaware that they should stop
use of OTC hearing aids due to the onset
of certain conditions, for example, ear
drainage, pain, and balance issues.
(Response) FDA agrees that certain
conditions should suggest that users
consult with a hearing healthcare
provider, but we do not agree that the
onset of such conditions necessarily
indicates the user should stop using
OTC hearing aids. FDA has revised the
labeling to make it more general so that
it warns users to see a doctor, preferably
an ear-nose-throat doctor, if the user
experiences any of the listed problems
before or after purchase.
(Comment 39) A few comments
recommended an additional warning on
the inside package labeling to alert
individuals that there is potential harm
when wearing hearing aids for longer
than recommended. Comments
proposed a warning to users to exercise
special care in the use of the device. It
would warn against use of the hearing
aid for more than 12 hours a day, for
example, and against use if the device
becomes uncomfortable, either due to
the loudness of sound or the physical fit
of the device. Such proposed warnings
sought to mitigate the risk of further
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impairment if the device was set to the
maximum output level and worn for
periods of time exceeding these
recommendations.
(Response) FDA is declining to
implement such suggestions. OTC
hearing aids are designed to be worn all
waking hours in a variety of listening
environments and situations. The
labeling required in this rule provides
reasonable assurance of safety and
effectiveness, including through notices
that the hearing aid sound output
should be neither uncomfortable nor
painful, and that the hearing aid should
not cause pain or discomfort when
inserting or placing it.
(Comment 40) A few comments
expressed concern that the labeling
lacked reference to how a hearing
healthcare professional can assist and
benefit a person purchasing an OTC
hearing aid. Comments recommended
FDA develop labeling that includes
guidance that, due to their specialized
knowledge, hearing healthcare
professionals are better at assisting in
hearing tests and maximizing the
benefits of a hearing aid.
(Response) FDA declines to make this
addition to the labeling. This rule
includes requiring specific language to
assist consumers in determining
whether an OTC hearing aid best meets
their needs and when to consult a
licensed professional. As mandated by
FDARA, this rule establishes
requirements to provide reasonable
assurance of safety and effectiveness of
OTC hearing aids without the
involvement of a licensed person;
therefore, while FDA agrees that
licensed professionals provide valuable
services, FDA will not be incorporating
further requirements to include
additional information about the benefit
of licensed professionals in the labeling.
(Comment 41) FDA proposed that the
outside package labeling include a
statement that the device may not be
useful for more significant hearing loss
or complicated hearing needs. Some
comments expressed concern that the
warning used ‘‘significant hearing loss’’
without providing a definition of how to
distinguish mild to moderate from
significant hearing loss. These
comments suggested that FDA further
delineate mild to moderate from
significant hearing loss, some of them
suggesting we use objective criteria
rather than more-subjective perceptual
terms.
(Response) The final labeling
requirements include the signs
suggestive of both perceived mild to
moderate hearing impairment and more
significant hearing impairment. FDA
included this information to assist
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consumers in determining whether OTC
hearing aids can meet their needs. We
have improved the phrasing of this
information to be more understandable
to inexperienced hearing aid users,
including by removing the phrases the
comments characterized as not defined
well enough. However, as discussed in
the response to Comment 24, FDA is
declining to define hearing impairment
in terms of objective criteria for the
reasons explained in that response. We
are continuing to delineate the different
degrees of severity with perceptual
terms as we believe this will be most
useful to the intended users.
(Comment 42) Comments expressed
concern that the symptoms suggesting
perceived mild to moderate hearing
impairment can also be indications of
more significant hearing loss.
(Response) FDA infers these
comments are concerned that
consumers may mistake their degree of
hearing loss due to the commonality of
symptoms. FDA disagrees. FDA has
specified some listening scenarios that
represent some of the most common
perceptual difficulties a user with
perceived mild to moderate hearing
impairment may experience. Although
these symptoms may apply to multiple
types and degrees of impairments, they
are most common to perceived mild to
moderate hearing impairment and
therefore helpful to prospective users of
OTC hearing aids. Further, FDA is also
requiring that the symptoms commonly
experienced by individuals with more
significant impairment, with a
recommendation to consult with a
hearing healthcare professional, be
included on the outside package
labeling. Although FDA is finalizing
more user-friendly language, we are
declining to modify the symptoms for
perceived mild to moderate hearing
impairment. We believe that this
information, along with the information
required in the labeling to assist people
with more severe impairment, will help
prospective users determine whether an
OTC hearing aid is a good choice for
them.
(Comment 43) A few comments
suggested labeling requirements include
notice to individuals younger than 18
years old who are experiencing hearing
issues that they should visit a hearing
healthcare provider prior to using
hearing aids due to complications that
can cause auditory impairment and
developmental issues.
(Response) FDA agrees with the
concerns expressed by these comments
and believes the labeling requirements
address these concerns. For example,
the labeling requirements in the
proposed rule, which are being finalized
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here, include language that individuals
under the age of 18 should consult with
a doctor and refrain from using OTC
hearing aids. It emphasizes the possible
need for medical testing and the
potential for hearing impairment in
younger people to affect speech and
learning.
(Comment 44) A few comments
recommended that labeling include an
explanation on the differences between
prescription hearing aids, OTC hearing
aids, and PSAPs to help consumers to
select the appropriate device.
(Response) FDA is declining to
require in the labeling an explanation of
the differences between OTC hearing
aids, prescription hearing aids, and
PSAPs. Although this information may
be helpful to know, it is not necessary
for reasonable assurance of safety and
effectiveness of OTC or prescription
hearing aids. The labeling requirements
for OTC hearing aids include common
symptoms of those with mild to
moderate hearing impairment and
symptoms of more significant hearing
loss to help consumers decide whether
an OTC hearing aid is a good choice for
them. Further, as discussed elsewhere
in this document, prescription hearing
aids must be sold only to or on the
prescription or other order of a licensed
practitioner (see § 801.109). Therefore, a
licensed practitioner will be involved in
determining whether a prescription
hearing aid is appropriate for an
individual with hearing impairment.
Additionally, FDA is issuing a guidance
with this final rule that will provide
additional clarification of the
differences between hearing aids and
PSAPs. The notification of availability
for the guidance appears elsewhere in
this issue of the Federal Register.
(Comment 45) A few comments
requested that OTC hearing aid labeling
include a warning that people should
not use OTC hearing aids if they have
tinnitus. Comments expressed concern
that tinnitus can be an indicator of
serious medical conditions requiring
proper management from a hearing
healthcare professional, and failure to
seek immediate treatment could cause
further harm.
(Response) In the labeling
requirements, FDA has included
tinnitus in one ear as a condition for
which users should seek medical
evaluation. FDA is declining to expand
upon this labeling requirement to
include tinnitus in both ears since
bilateral tinnitus often occurs in the
presence of any degree of hearing loss.
As such, the warning would be overly
broad if it were to include bilateral
tinnitus.
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(Comment 46) A few comments
suggested modifying the proposed
language recommending users consult a
hearing healthcare professional if they
remain concerned about their hearing or
struggle to use the device. The
comments suggested that the labeling
recommend users first contact the
manufacturer to allow them an
opportunity to resolve any issues.
(Response) FDA is declining to
implement this suggestion. The
statement notifies users that
dissatisfaction with the compensation
for impaired hearing may call for the
attention of a hearing healthcare
professional. Although FDA sees the
potential benefit in users consulting
with manufacturers to resolve certain
technical or use questions, the purpose
of the note is not to assist with device
troubleshooting. Manufacturers may,
however, include a troubleshooting
section (or similar section) in the user
instructions and provide suggestions for
when users should consult them for
technical or use issues that would not
necessarily call for the involvement of a
hearing healthcare professional.
(Comment 47) Some comments
requested FDA require the labeling on
and/or inside the package of OTC
hearing aids include information about
telecoils. Comments expressed concern
that first-time hearing aid purchasers
will not be able to make informed
decisions about telecoils without an
explanation of telecoil capabilities.
Specific labeling suggestions varied, but
they included statements of whether the
device includes telecoils, explanations
of what telecoils are, and the benefits
telecoils may provide.
(Response) FDA is declining this
suggestion because not all OTC hearing
aids will have telecoils, and existing
requirements would apply, for example
for adequate directions for use (see
section 502(f)(1) of the FD&C Act and
§ 801.5). (See also the response to
Comment 94 about requiring telecoils.)
Including the information about the
feature could be confusing to consumers
when the device does not include
telecoils. Conversely, if a hearing aid
includes telecoils, information about
them would be necessary to provide
adequate directions for use, so the
information would have to appear in the
labeling (see section 502(f)(1) of the
FD&C Act and § 801.5).
(Comment 48) Some comments
requested that labeling for OTC hearing
aids include a questionnaire to assist
consumers in deciding if OTC hearing
aids are appropriate for them.
Comments recommended the
questionnaire to assist consumers in
determining if they have a medical
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condition that requires a visit to a
hearing health care provider prior to
using OTC hearing aids.
(Response) FDA will not be
implementing this suggestion. The
labeling requirements we are finalizing,
including information on Red Flag
conditions and symptoms of more
significant hearing loss, are sufficiently
informative to provide reasonable
assurance of safety and effectiveness
without the additional time and effort
necessary to complete a questionnaire
and assess the results for purposes of
deciding whether an OTC hearing aid is
appropriate.
(Comment 49) A few comments
expressed concern about the note
regarding what a hearing aid can do,
which includes a statement that, if a
user has hearing loss in both ears, use
of hearing aids for both ears (bilateral
hearing aids) may provide more benefit
than just one hearing aid. Comments
suggested that this may discourage
individuals who wish to begin with
only one hearing aid. Comments
recommended removing this paragraph
from the note.
(Response) FDA disagrees that this
statement would deter individuals from
using one hearing aid. This statement
does not suggest that individuals must
use two hearing aids in all cases. This
statement in the note simply conveys
that two OTC hearing aids may provide
more benefit in the case of hearing loss
in both ears. Moreover, should
individuals with hearing loss in both
ears start with one OTC hearing aid and
desire more benefit, this information
would be useful to help them
understand how to achieve greater
benefit.
(Comment 50) A few comments
requested that the labeling include
guidance as to what to do when an
eartip gets stuck in the ear canal.
(Response) FDA infers that the
information requested by comments is
meant to assist users in determining
when to consult a healthcare
professional. FDA agrees that providing
guidance to users on this issue is
important. We have updated the
labeling to help users decide when to
seek medical help (see new
§ 800.30(c)(2)(iii)(C)).
3. Outside Package Labeling and
Purchasing Decisions
(Comment 51) A few comments
recommended a statement for
individuals with ability limitations,
such as a developmental disability,
similar to statements directing people
under the age of 18 to seek examination
and evaluation by hearing healthcare
professionals. Commenters implied that,
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just as with individuals under 18,
individuals with ability limitations may
not have the same ability to determine
their hearing loss or the presence of
more serious medical issues; therefore,
evaluation by a licensed professional
would be necessary.
(Response) FDA is declining to
implement this suggestion. The
statements addressed to those under age
18 concern hearing healthcare needs
that are specific to younger people, such
as speech and learning difficulties.
Additionally, as explained in the
proposal, the use of OTC hearing aids in
people younger than 18 presents risks to
health beyond those typically associated
with use in older people. Whereas
hearing loss in older adults is most
commonly related to noise exposure and
aging, the etiology (causes) of hearing
loss in younger people is varied and
may result from conditions that warrant
prompt diagnosis to avoid serious risks
to health (see 86 FR 58150 at 58158).
The comments provided no information
to support that adults with ability
limitations face similar risks to those
younger than 18.
Further, we have revised the labeling
with more user-friendly terms
throughout. We believe the information
required in the labeling, including
statements identifying Red Flag
conditions and advising users to consult
with a hearing healthcare professional if
they continue to struggle with or remain
concerned about their hearing, are
appropriate for adults with perceived
mild-to-moderate hearing impairment.
We do not agree that revising the
labeling or limiting purchases for
certain adults in the manner suggested
by the comments is necessary to provide
reasonable assurance of safety and
effectiveness of OTC hearing aids.
(Comment 52) A comment requested
that FDA standardize the names of
hearing aid features so that interested
people could compare products more
easily. In that vein, multiple comments
suggested that FDA develop a rating
system to compare features. The
commenter expressed that information
should be accessible to lay users and
that relying on a regulatory guidance
document, should FDA issue one in the
future, to convey such information is
unlikely to assist most consumers, who
are not experts in hearing aid
technology. Similar comments desired a
rating system for device performance in
certain conditions, for example, live
concerts.
(Response) FDA agrees that interested
people should have sufficient
information to compare products as
easily as possible, and we have made
various revisions in this final rule to
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improve the usefulness of the required
labeling for laypeople. We are also
finalizing a requirement for a
conspicuous mark identifying the
hearing aid as OTC that we expect will
help purchasers and others distinguish
product categories (see Additional
Revision 2 in section III.D.3). Further,
FDA’s website describes common
hearing aid technologies and features to
help orient consumers with the
technology and terminology, available
at: https://www.fda.gov/medicaldevices/hearing-aids/types-hearing-aids.
However, we are not making additional
revisions in the final rule to standardize
the names of device features.
We note that a number of regulatory
requirements will nevertheless assist
consumers to compare devices and
features. For example, the applicable
classification regulation for a device
specifies the name of the device type (so
is standardized in that way), and the
principal display panel on the package
of an OTC device must display a
statement of identity that includes the
common name of the device, in bold
typeface (see § 801.61). Further, the
labeling must include adequate
directions for use that allow a layperson
to use the device safely and for its
intended purpose(s) (see § 801.5). And
for OTC hearing aids, we proposed and
are finalizing a requirement under new
§ 800.30(c)(4) that the labeling include
certain technical specifications.
Purchasers interested in the
electroacoustic performance could use
this information to compare across
devices.
We acknowledge that manufacturers
may use proprietary names for device
features, even when other
manufacturers offer a similar feature
under a different name (perhaps also
proprietary). However, FDA expects that
hearing aid technology will continue to
evolve and that device features will
similarly evolve, including the specific
capabilities. Precisely identifying,
describing, and naming those features
and ways to compare them by
regulation, even for the present, is
neither practical nor necessary. Further,
individuals may have different
preferences as to which features are
more valuable in a hearing aid. For
similar reasons, a rating system is
neither practical nor necessary. Even
with additional standardization of
terminology, the import of each feature
may still not be apparent to purchasers,
and similarly, rating systems may not
reflect (rate highly) the features of a
device that a given purchaser would
value. Thus, finalizing regulatory
requirements for such a system of
comparison is not likely to
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communicate useful information to
purchasers and may hinder innovation
by codifying current characteristics of
device features.
To communicate useful information,
we expect that manufacturers will
describe their devices’ features in ways
that best appeal to the intended users,
and the labeling of a hearing aid will
have to be available to prospective users
prior to purchase (see new
§§ 800.30(c)(2) and 801.422(c)(2)).
Moreover, the labeling of a device must
not be false or misleading in any
particular (see 21 U.S.C. 352(a)(1)).
These requirements will help ensure
that purchasers have accurate
information about a hearing aid and its
features in a way that allows them to
compare these devices.
As for ratings for device performance
in certain conditions, given the
subjective nature of user preferences,
developing a useful rating system is
impracticable. We expect that
purchasers will have access to a wealth
of opinions from other purchasers,
product testers or reviewers, and
consumer information organizations.
This will allow purchasers to find
ratings that reflect their interests more
than any possible criteria standardized
by regulation. For example, a purchaser
may prefer OTC hearing aids that users
rate highly for use in a restaurant.
Additionally, user preferences may
change in the future, so any rating
system may become quickly outdated.
Regarding device performance more
generally, as we explained in the
proposal, we are establishing
electroacoustic performance
requirements for high-fidelity
amplification (see 86 FR 58150 at
58163). A hearing aid must meet these
requirements to be available OTC, but
the device need not outperform them.
By extension, a device need not perform
better than a high-fidelity level of
amplification. Establishing a rating
system for compliant devices, that is, for
those that would already have high
fidelity, would incorrectly imply some
devices are substandard. We are not
finalizing requirements for describing
how well a device performs beyond the
electroacoustic performance
specifications in the labeling, the
performance itself being required to
meet a standard for high fidelity.
(Comment 53) A few comments
recommended that information about
whether a battery was included, and
what type of battery is required, be
included on the labeling. Comments
recommended the inclusion of this
information so that consumers can
purchase the necessary batteries at the
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same time as the OTC hearing aid and
adequately compare OTC hearing aids.
(Response) We agree that it is
important for manufacturers to include
information about the type, as well as
the number, of batteries, and whether
batteries are included because this is
information consumers will need to use
the hearing aid. Therefore, FDA is
revising the final rule to require this
information on the labeling outside the
package of the hearing aid so that
consumers are aware of the battery
requirements prior to, or at the time of,
purchase.
(Comment 54) A few comments
recommended including a description
of any smartphone compatibility
requirements to operate the hearing aid
on the outside package labeling.
Comments argued this would allow
consumers to determine if they have the
necessary device and programming to
operate the hearing aid prior to
purchase.
(Response) FDA agrees with the
comments that this information is
important for consumers to know when
comparing OTC hearing aids at the
retailer. Similar to the battery
information discussed above,
information on the control platform is
necessary for use of the hearing aid.
Therefore, FDA is revising the final rule
to require that the outside package
labeling indicate whether a mobile
device or other non-included control
platform is required, such as a
smartphone, a remote sold separately, or
a personal computer. The labeling also
will have to indicate the type of control
platform and how the hearing aid
connects to the control platform, for
example, via Bluetooth and/or USB–C.
(Comment 55) A few comments
suggested that the rule require a list of
other basic features of each OTC hearing
aid (for example, mobile operating
system, volume controls, feedback,
telecoil, or accessories) on the outside
package. Comments expressed concern
that, without a list of features,
consumers may have difficulty
comparing different OTC hearing aids
and make an informed decision.
(Response) FDA is declining to
implement this suggestion in its
entirety. The packaging provides limited
space for required labeling, and while
we have adopted some such
suggestions—see the responses to
Comment 53, about batteries, and
Comment 54, about smartphone
compatibility—we have not determined
that the other information is necessary
on the outside package labeling to
provide reasonable assurance of safety
and effectiveness. Additionally, we are
finalizing the requirements as proposed
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that the inside package labeling, among
other requirements, provide
illustration(s) of the OTC hearing aid
that indicates operating controls, user
adjustments, and the battery
compartment (see § 800.30(c)(2)(iv)),
provide information on the function of
all controls intended for user
adjustment (see § 800.30(c)(2)(v)), and
describe any accessory that
accompanies the OTC hearing aid (see
§ 800.30(c)(2)(vi)). As the inside package
labeling must be made available prior to
purchase (see § 800.30(c)(2)), consumers
will be able to access this information
prior to purchase. Further, as discussed
in the response to Comment 26, any
OTC hearing aid must have labeling that
bears adequate directions for use that
allow a lay user to use the device safely
and for its intended purposes (see
§ 801.5). In cases where necessary for
adequate directions for use, information
on other features not specified in
§ 800.30(c) will have to appear in the
labeling, and prospective users will
have access to the labeling prior to
purchase.
(Comment 56) Some comments
expressed concerns for device labeling
that states an OTC hearing aid is ‘‘FDA
approved,’’ ‘‘FDA cleared,’’ or otherwise
endorsed by the FDA. The comments
asserted that such labeling indicates
that: FDA has inspected an OTC device
for quality and/or compliance with
applicable legal requirements, that FDA
has approved the device for use by the
individual purchaser, and/or that FDA
favors the device over others without
such labeling. The comments argued
that such indications are misleading for
purchasers.
(Response) FDA does not endorse
particular devices and representations
of such in labeling can be false or
misleading. The determination of
whether ‘‘FDA cleared,’’ ‘‘FDA
approved,’’ or similar language on a
device’s labeling suggests FDA
endorsement of the device or is
otherwise false or misleading is made
on a case-by-case basis.
Clearance of a device indicates that
FDA has determined the device to be
substantially equivalent to a class I or II
device. It does not in any way denote
official approval of a device or in any
way imply that the device is in
compliance with any other pertinent
sections of the FD&C Act (see 41 FR
37458 at 37462, September 3, 1976).
Likewise, a grant of a De Novo
classification request under 21 CFR
860.260(a)(1) or compliance with
registration and listing requirements
under part 807 does not denote official
approval or imply compliance with
other pertinent device requirements.
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Any representation that creates an
impression of official approval of a
device due to complying with
requirements for premarket notification
or registration is misleading and
constitutes misbranding (see §§ 807.97
and 807.39, respectively).
The labeling of a device may be false
or misleading for other reasons too. For
example, if a statement in the labeling
creates an impression that FDA
officially favors one classified device
over another, it would likely be false or
misleading. Or, if the labeling uses
FDA’s logo, creating an impression that
FDA has endorsed the product, it would
likely be false or misleading.8 A device
would be deemed to be misbranded
under section 502(a)(1) of the FD&C Act
if its labeling included such false or
misleading statements. The FD&C Act
prohibits doing or causing certain acts
with respect to a misbranded device
(see, e.g., 21 U.S.C. 331(a)–(c), (k)).
(Comment 57) A comment requested
clarification on the applicability of
prescription labeling requirements
under new § 801.422 to the implantable
components of a bone-conduction
hearing aid. The comment argued that
applying the labeling requirements to
the implantable components is
unnecessary because a surgeon has
already decided to implant specific
components, and the labeling under
new § 801.422 is neither necessary nor
helpful for the surgeon or the hearing
aid user. In contrast, the nonimplantable components of a boneconduction hearing aid, such as the
sound processor, are often marketed
separately and not necessarily through a
physician.
(Response) FDA agrees that the
labeling requirements under § 801.422
are not necessary for reasonable
assurance of safety and effectiveness
with respect to the implantable
components of a bone-conduction
hearing aid. We have modified the
classification regulation to clarify that
the labeling requirements for
prescription hearing aids apply only to
the non-implantable components of a
bone-conduction hearing aid. In cases
where the implantable components are
not sold or distributed with the nonimplantable components, the
implantable components need not bear
the labeling under new § 801.422.
(Comment 58) One comment
requested that FDA strike
§ 801.422(c)(1)(ii)(A). The comment
stated that the decision to offer trial
8 FDA’s logo is not for use on private sector
materials, including device packaging. For more
information, you may wish to review FDA’s logo
policy, available at: https://www.fda.gov/about-fda/
website-policies/fda-logo-policy.
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rentals or purchase options is a trade
issue and does not relate to the safety or
effectiveness of the device.
(Response) FDA has decided to retain
§ 801.422(c)(1)(ii)(A) (in the final rule,
this information is in
§ 801.422(c)(1)(i)(C)). FDA notes that
§ 801.422(c)(1)(ii)(A) does not require
offering a trial-rental or purchase-option
program. Instead, this provision just
requires that the outside package
labeling for a prescription hearing aid
include information advising
prospective users to inquire about the
availability of a trial-rental or purchaseoption program.
FDA also notes that
§ 801.422(c)(1)(ii)(A) is substantially
identical to what was already required
to be included in the user instructional
brochure for a hearing aid under former
§ 801.420(c)(3). In other words, the
information required under
§ 801.422(c)(1)(ii)(A) is not new and has
been required to be in hearing aid
labeling for many years. The only
differences between §§ 801.420(c)(3)
and 801.422(c)(1)(ii)(A) are:
§ 801.422(c)(1)(ii)(A) applies only to
prescription hearing aids,
§ 801.422(c)(1)(ii)(A) requires that the
information be provided on the outside
package labeling for a prescription
hearing aid, and the required statement
under § 801.422(c)(1)(ii)(A) uses
language that is easier to understand.
FDA continues to believe that this
labeling requirement is necessary to
provide reasonable assurance of safety
and effectiveness of prescription hearing
aids. When FDA included the
requirement in former § 801.420(c)(3) to
provide information in the user
instructional brochure advising
prospective users to inquire about the
availability of a trial-rental or purchaseoption program, FDA acknowledged the
difficulty of determining in advance
whether an individual will benefit from
a hearing aid, and we noted that
voluntary trial-rental or purchase-option
programs for prospective hearing aid
users were available (42 FR 9286 at
9289).
FDA believed that trial-rental or
purchase-option programs, which
provide prospective hearing aid users
the opportunity to wear the selected
hearing aid so that the user can make an
informed judgment on whether a benefit
is obtained from the use of the hearing
aid, were important to the welfare of the
hearing impaired and therefore,
required that the user instructional
brochure contain information advising
prospective users to inquire about the
availability of such program (42 FR 9286
at 9289). FDA explained that this
information would help assure that the
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selected hearing aid would be beneficial
and would encourage hearing aid use
among those prospective users who lack
the motivation to try a hearing aid
because of the fear that they will spend
a great deal of money with no guarantee
of benefit (42 FR 9286 at 9289). FDA
believes that the reasons for requiring
this information in labeling continue to
apply for prescription hearing aids,
which are typically sold through
licensed hearing aid dispensers, many
of whom offer such programs.
(Additional Revision 2) In response to
various concerns evident in the
comments, we are including in this final
rule a requirement that the principal
display panel of the outside package
labeling of an OTC hearing aid bear the
conspicuous marks, ‘‘OTC’’ and
‘‘hearing aid.’’ FDA intends these marks
to clarify for purchasers and others,
including retailers and State agencies,
whether a product is a hearing aid
(regulated as a device), and whether it
is available OTC. (See also the response
to Comment 18 discussing hearing aid
terminology.) However, these marks do
not in any way denote official approval
of the device, and any representation
that creates an impression of official
approval because of complying with
these marking requirements or with the
OTC Hearing Aid Controls would be
considered false or misleading and
constitute misbranding. (See also the
response to Comment 56 regarding other
false or misleading statements.) The
marking is necessary for reasonable
assurance of safety and effectiveness of
OTC hearing aids because it provides
assurances that non-OTC hearing aids or
non-devices will not be confused for
OTC hearing aids.
The marks must have the same
prominence as required under
§ 801.61(c) for the device’s statement of
identity, and a manufacturer may satisfy
this new marking requirement if the
statement of the device’s common name
includes both ‘‘OTC’’ and ‘‘hearing aid.’’
For example, a manufacturer may label
its product as a ‘‘Self-Fitting OTC
Hearing Aid’’ (assuming the device’s
common name is ‘‘self-fitting hearing
aid’’). Such a device would meet this
new marking requirement as well as the
requirement for the common name in
the statement of identity. Alternatively,
the manufacturer may, for example,
label its product without including the
marks in the common name of the
device, perhaps by placing ‘‘OTC’’ in a
corner of the principal display panel
with the required prominence
(assuming the device’s common name
includes ‘‘hearing aid’’). Formatting the
marks, for example, by outlining them
with a box, would be permissible
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provided the formatting does not cause
the marks to lack the required
prominence (see 21 CFR 801.15(a)(6)).
4. Labeling Inside the Package and
Technical Matters
(Comment 59) A few comments
requested that the frequency response
and ANSI S3.22 specifications of OTC
hearing aids be included in the user
manual.
(Response) FDA infers this request is
to assist in selecting an OTC hearing aid
with optimal performance. We are not
requiring the requested information in
OTC hearing aid labeling because, as we
explained in the proposal, this
information is highly technical and
generally not useful to the lay user (see
86 FR 58150 at 58163). However, we are
finalizing the proposed requirement that
OTC hearing aid labeling include key
electroacoustic performance
specifications that are more likely to
assist prospective lay users in
comparing and selecting the devices,
including the values for maximum
output, full-on gain, total harmonic
distortion, self-generated noise, latency,
and upper and lower cutoff frequencies
for the acoustic bandwidth.
(Comment 60) A few comments
expressed concern that requiring
summaries of clinical studies conducted
by or for the manufacturer on the inside
labeling is not practical. Comments
suggested that providing a link to an
online library of the clinical studies and
a summary of each study on the
manufacturer’s website would suffice.
(Response) FDA disagrees that
providing summaries of clinical studies
in the labeling inside the package is
impractical. While we understand that
fully appreciating the outcomes of a
study can entail a lengthy technical
document, presenting the most
important findings regarding the
performance of the OTC hearing aid, in
a user-friendly format, need not take
significant space in the labeling. We are
finalizing the requirement as proposed.
(Comment 61) A few comments
requested that the labeling include
information on how the OTC hearing
aid can be fixed or repaired. Comments
requested that the information include
whether a local hearing healthcare
professional can repair the device or if
it needs to be sent to the manufacturer.
Comments argued this would allow
prospective users to make an informed
decision when purchasing their devices.
(Response) FDA agrees that
manufacturers should provide users
with information on how to have their
hearing aid repaired because this
information may be difficult for users to
obtain on their own. The inside package
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labeling requirements now include
information on how and where to obtain
repair service or replacements, with at
least one specific address where the
user can go or send the OTC hearing aid
to obtain such repair service or
replacements.
(Comment 62) A few comments
expressed concern that estimating the
expected battery life will be difficult for
manufacturers due to inconsistencies
between batteries and use conditions.
Comments proposed removing this
requirement from the labeling inside the
package.
(Response) FDA recognizes that
battery performance can vary but will
retain this requirement in the final rule
because this information will help
prospective purchasers determine
whether a hearing aid will be suitable
for their circumstances. Recognizing
that performance can vary from device
to device, we did not propose, and are
not requiring, a specific method of
estimating the battery life. However,
manufacturers may want to review
Clause 4.7 (Battery Life) of ANSI/CTA–
2051:2017, which currently provides an
acceptable method to estimate the
battery life (Ref. 8).
(Comment 63) A comment proposed a
requirement for OTC hearing aid
labeling to include information about
the transport methods for configuration
information and other data to and from
the OTC hearing aid with all points
along the supply chain.
(Response) FDA is not adopting this
proposal because such information is
focused on the electronic transfer of
non-diagnostic data and is not generally
necessary for reasonable assurance of
safety and effectiveness of all OTC
hearing aids. We note, however, that
should States establish or continue in
effect requirements to disclose such
information, and the requirements are
not specifically applicable to hearing
products, section 709(b)(4) of FDARA
likely would not preempt them.
However, FDA is not opining on
whether such disclosure requirements
likely would or would not be preempted
under section 521(a) of the FD&C Act.
(See also the response to Comment 115
concerning the collection of personal
information as part of a sale of an OTC
hearing aid.)
(Comment 64) A comment requested
that FDA require labeling that specifies
the latency of any wireless streaming
technologies the OTC hearing aid uses.
(Response) In certain circumstances,
latency information in the labeling may
be necessary under existing
requirements. For example, if the
information is necessary to provide
adequate directions for use or necessary
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for practitioners licensed by law to use
the device safely and for its intended
purpose(s), then the latency information
would have to appear in the device
labeling (see §§ 801.5 and 801.109(c),
respectively).
However, as a general matter for
hearing aids that incorporate wireless
streaming technology, FDA has
determined that stating the streaming
latency is not necessary to provide
reasonable assurance of safety and
effectiveness. Additionally, a variety of
factors can affect wireless streaming
latency, including nearby radio
interference, distance between the
transmitter and receiver, and the
presence of materials that absorb certain
radiofrequencies. As such, a
standardized wireless streaming latency
value may not reflect a particular
device’s design or the environment in
which the user wears the hearing aid;
and thus, FDA is not adding a
requirement to include wireless
streaming latency information for all
OTC hearing aids in this rule. We note
that FDA is finalizing requirements for
OTC hearing aid labeling to include
manufacturer contact information. If
users or prospective users are interested
in the streaming latency specifically,
they will be able to contact the
manufacturer.
(Comment 65) A few comments
requested a labeling requirement
describing the fitting range across
different frequencies (500, 1000, 2000,
and 4000 Hertz) to help consumers
determine the suitability of different
OTC hearing aids to meet their needs.
(Response) FDA understands that
traditionally, hearing aids are designed
and marketed with a specific fitting
range in mind, and manufacturers may
maintain this practice. However, OTC
hearing aids are intended to be available
without the involvement of a licensed
person (see 21 U.S.C. 360j(q)(1)(A)(v)).
As such, FDA is not using audiometrydefined thresholds or ranges of hearing
loss in the final rule. Instead, FDA is
using descriptions of common
symptoms of mild to moderate hearing
impairment in the labeling. As such,
describing the fitting ranges across
different frequency bands is not
necessary for reasonable assurance of
safety and effectiveness of OTC hearing
aids. However, manufacturers may
choose to include this information in
device labeling, and prospective users
will have access to the manufacturer’s
contact information prior to purchase
should they desire to inquire about the
fitting ranges.
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5. Adverse Event Reporting
(Comment 66) The proposed labeling
included instructions on reporting
adverse events through the MedWatch
portal, https://www.fda.gov/Safety/
Medwatch, or by phone, 1–800–FDA–
1088. A few comments requested that
email and mailing options also be
provided for adverse event reporting.
Comments further recommended that
FDA provide a receipt of the complaint
to individuals.
(Response) We are declining to
include a mailing address in the
labeling because submissions by mail
should be on a MedWatch form, for
example, the Consumer Voluntary
Reporting Form (FDA 3500B), which
contains the address along with
additional instructions. Reference to just
the address in hearing aid labeling may
result in reports submitted in an
unexpected manner and format,
potentially causing confusion,
incomplete reports, and significant
delays in processing them. However, in
addition to reporting events through the
MedWatch portal and 1–800–FDA–
1088, consumers can submit their
adverse event reporting form to FDA by
fax or the mailing address according to
the instructions on the form. Submitters
will receive a reply from FDA after we
receive their report. Email is not
currently an alternative to the
MedWatch online submission system.
(Comment 67) A few comments
recommended that in addition to
labeling information on reporting
adverse events to FDA, contact
information for manufacturers should be
required so that manufacturers are
provided the opportunity to review
adverse events. Comments implied that
providing manufacturers with
awareness about adverse events and
opportunity to address them would be
beneficial to consumers.
(Response) To help facilitate
communications between users and
manufacturers, FDA has added the
manufacturer’s email and mailing
address to the labeling requirements
(see final § 800.30(c)(1)(i)(E)). Should
users wish to report adverse events to
the manufacturer, they may use this
information to do so. Manufacturers
may also include instructions in the
labeling, that do not conflict with the
labeling requirements, on how to
directly report adverse events to them.
(Comment 68) FDA included in the
proposed labeling examples of adverse
events to be reported to FDA: irritation
of the ear canal or outer ear skin, injury
from the device (like cuts or scratches,
or burns from an overheated battery),
pieces of the device getting lodged in
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the ear canal, and sudden increased
severity in hearing loss with the device.
Some commenters suggested limiting
the list to more-serious conditions to
avoid the adverse reporting system
being overwhelmed by reports of minor
adverse events. Commenters expressed
concern that if the labeling were
finalized as proposed, more serious
adverse events may get lost in the
volume of what the commenters see as
minor. Commenters recommended
adverse event reporting be limited to
significant injury and/or death.
(Response) FDA is declining to limit
the examples of adverse events, or the
reporting of adverse events, to
significant injury and/or death. FDA is
interested in receiving information on
all adverse events to have a better
understanding of OTC hearing aid
product safety and performance.
Additionally, under section 709(d) of
FDARA, FDA is required to submit a
report to Congress ‘‘analyzing any
adverse events related to over-thecounter hearing aids.’’ FDA is prepared
to review adverse event reports and has
experience in sorting through adverse
event reporting data to identify safety
signals and trends.
(Comment 69) Comments requested
that users of prescription hearing aids
be able to report adverse events to FDA
similar to how OTC hearing aid users
can report through the MedWatch portal
at https://www.fda.gov/Safety/
Medwatch, or by phone, 1–800–FDA–
1088.
(Response) We agree that prescription
hearing aid users should also report
adverse events to FDA. We proposed
and are finalizing the same note for
prescription hearing aids to notify users
of how to report adverse events to FDA.
6. Miscellaneous Labeling
Considerations
(Comment 70) Some comments
recommended that restrictions on the
use of OTC hearing aids by individuals
under the age of 18 be removed.
Comments expressed the need for cost
effective hearing aids for individuals
under 18. Additionally, comments
asserted that individuals under 18 are
increasingly suffering from hearing loss
as a result of exposure to loud sounds,
which they argued is hearing loss that
can be addressed by OTC hearing aids.
(Response) FDA is declining to allow
the sale of OTC hearing aids to
individuals under the age of 18. This
condition for sale is consistent with
section 709(b)(2)(C) of FDARA and
section 520(q)(1)(A)(ii) of the FD&C Act,
which establish that OTC hearing aids
are only intended for people aged 18
and older. The use of OTC hearing aids
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in people younger than 18 presents risks
to health beyond those typically
associated with use in older people.
While FDA appreciates the need for cost
effective hearing aids for individuals
under the age of 18, the sale of OTC
hearing aids will be limited to
individuals who are age 18 and older.
(Comment 71) A few comments
expressed concern that the
manufacturer contact information that
FDA proposed to include in the labeling
of OTC hearing aids is limiting because
the only alternative to a website address
was a telephone number. Comments
argued that many individuals with
hearing loss do not prefer to
communicate using the telephone and
recommended the inclusion of the
manufacturer’s email and mailing
address on labeling to provide greater
access to users.
(Response) FDA agrees that providing
additional ways for users to
communicate with manufacturers will
allow for users to resolve issues with
their hearing aids more easily. The
labeling requirements have been
updated to include the manufacturer’s
mailing address and email address.
(Comment 72) A few comments noted
that hearing aids are physically small
and do not have room for a serial
number on them. Comments
recommended that the serial number be
located on an accompanying item, such
as on the storage case or registration
card.
(Response) FDA is declining to
implement this suggestion.
Manufacturers have been complying
with this long-standing requirement for
labeling under § 801.420, which we are
revising and renumbering as § 801.422,
and marking the serial number on the
device itself (since 1977). Additionally,
because accompanying items can be
misplaced, marking the device itself is
essential to the utility of the serial
number.
(Additional Revision 3) As noted in
the response to Comment 8, we are
finalizing labeling requirements for
hearing aid software. We expect much
of the labeling to be electronic in nature,
for example, the graphic and printed
matter that appear on a download web
page or in electronic display ‘‘cards’’ or
dialogs in the software’s user interface.
As such, electronic labeling may have a
transitory nature, and we are specifying
the occasion and persistence of
presentation. For example, we are
requiring that the labeling present a
warning against use in people younger
than 18. In this example, the electronic
labeling, perhaps appearing in a modal
dialog, need not appear at all times.
Rather, we are requiring that the
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labeling present the warning to the user
prior to first use of the software and
persist until the user acknowledges it.
We are further requiring that the
software provide access to all of its
labeling for later review, for example,
through a Help menu selection.
We intend the software device
labeling requirements to correspond
with the labeling requirements we
proposed for packaged hearing aids to
the greatest extent possible. As such, we
are requiring that the software device
labeling present certain information
prior to first use or obtaining payment
information for the software (not
necessarily the hearing aid or
amplification platform), reflective of the
nature of the information we are
requiring on the packaging, that is,
information the prospective user should
know prior to purchase, if a purchase is
involved. Some labeling is required
prior to first use, but it could appear
after purchase of the software, if a
purchase is involved. Other labeling is
required to be accessible in the software,
but it need not be presented at any
particular time.
We recognize that some of the
information required in the labeling
under final § 800.30(c)(1) through (4)
may not apply to software. For example,
specific instructions for cleaning and
disinfection likely would not apply to
stand-alone software (see final
§ 800.30(c)(2)(vii)(D)). As another
example, an illustration of the battery
compartment likely would not apply
(see final § 800.30(c)(2)(iv)). To address
this, we made it clear that certain
information is required to the extent
applicable. Thus, in the first example,
the software device labeling need not
include instructions for cleaning and
disinfection if that information is not
applicable. In the second example, the
software device labeling must include
an illustration(s), but not necessarily of
the battery compartment if not
applicable. Further, in that example, a
video would be an adaptation of and
suffice for an illustration(s). Although
software may not have a principal
display panel like a packaged hearing
aid, a software-loading or Home screen
could serve a similar function to
provide the information required under
§ 800.30(c)(1)(iii).
We have also included requirements
for the software device labeling to
disclose compatibility requirements as
well as any fees or payments. Disclosure
of compatibility requirements is
necessary for reasonable assurance of
safety and effectiveness because this
information describes some of the
necessary conditions under which the
software device will be usable and thus
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safe and effective. The disclosures of
any fees or payments are similarly
necessary because they describe
necessary conditions under which the
software or additional features will start,
continue, and/or cease to operate safely
and effectively.
The software labeling requirements
we are finalizing under new
§ 800.30(c)(5) are in addition to any
other applicable requirement, including
special controls. For example, 21 CFR
801.50, regarding labeling requirements
for stand-alone software, would still
apply to the software when appropriate
under that regulation. As another
example, the general requirements for
adequate directions for use (see section
502(f)(1) of the FD&C Act and § 801.5)
would also apply, unless the software
device is exempt under § 801.109.
We are adding similar software device
labeling requirements in § 801.422.
E. Output Limits (§ 800.30(d))
Generally, comments on the output
limits for OTC hearing aids either
agreed that FDA’s proposed limits were
appropriate or comments proposed
lower limits. Several comments
recommended output limits that depend
on device design, for example volume
control, compression, or a limit on gain.
FDA received many comments on this
subject, some of which included
references to published scientific
literature, consensus standards,
stakeholder position papers, and public
health guidelines. For the following
reasons, we are finalizing lower output
limits than we proposed—111 and 117
dB SPL, which are multiples of 3-dB
reductions from the proposal—but we
are not including a separate gain limit.
1. Finalizing Lower Output Limits
After further considering the potential
risk of worsening users’ hearing
impairments as discussed below, as well
as the literature submitted to us in the
comments (e.g., Refs. 10 and 11), we
have decided to finalize lower output
limits than we proposed. We are
retaining the conditional structure of the
output limits, with the higher output
permitted for devices with activated
input-controlled compression. (See the
response to Comment 87 about requiring
a user-adjustable volume control for all
OTC hearing aids.) We are also retaining
the limits expressed as Output Sound
Pressure Level 90 (OSPL90) values
rather than A-weighted values as
suggested by some comments. OSPL90
values are more common expressions of
hearing aid outputs, and they are
consistent with the consensus standards
we are adopting, which refer to OSPL90
values.
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Comments suggested a variety of
lower limits, but we are adopting a
general limit of 111 dB SPL, which is
sufficient to mitigate the greater risk
potential from both acute high-outputlevels and cumulative exposure that we
identified after further consideration.
We are correspondingly finalizing the
higher conditional limit of 117 dB SPL
for devices with activated inputcontrolled compression.
Many commenters suggested an
output limit of 110 dB SPL and
considered this output limit sufficient to
address even moderate impairment, as
each commenter defined the term
‘‘moderate.’’ However, as discussed
further below, we have applied an
equal-energy principle and used a 3-dB
exchange rate in revising the general
output limit to 111 dB SPL. We do not
believe that an output limit of 110 dB
SPL would provide any meaningful
difference with regard to safety.
The output limits that we are
finalizing balance safety and
effectiveness without unduly sacrificing
either. We are not adopting the even
lower limits suggested in some
comments because these lower limits
would reduce device effectiveness for
people with perceived mild to moderate
hearing impairment to such a degree
that the limits would exclude some
intended users from obtaining sufficient
benefit of OTC hearing aids. At the same
time, progressively lower output limits
yield diminishing returns in terms of
safety. Thus, lowering the output limit
even further as suggested in some
comments would begin excluding
intended users without achieving
meaningful improvements in safety for
them. As a result, lowering the output
limits even further as suggested in some
comments would not provide
reasonable assurance of effectiveness for
people with perceived mild to moderate
hearing impairment, and thus would not
be ‘‘appropriate’’ for OTC hearing aids
per section 709(b)(2)(B) of FDARA.
The reduction in effectiveness and
benefit would result primarily because,
with even lower output limits, the
hearing aid would no longer have a
sufficient dynamic range (‘‘headroom’’)
for high-fidelity amplification. The
hearing aid could then apply
compression and/or other output
limiting measures more often or to a
greater degree, resulting in perceptibly
lower-fidelity (less effective)
amplification. In such circumstances,
OTC hearing aids would have
significantly reduced effectiveness for
the intended users, sometimes even in
normally non-hazardous environments.
This reduction in effectiveness would
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be increasingly noticeable for intended
users as the device output is reduced.
By way of comparison, a comment
urging FDA to adopt an output limit of
102 dB SPL also urged FDA to limit the
intended users of OTC hearing aids to
people with mild impairment rather
than mild to moderate impairment. As
we explain in the response to Comment
10, we are not so limiting the OTC
category, and an output limit that low
would not provide reasonable assurance
of safety and effectiveness in addressing
perceived mild to moderate hearing
impairment. As provided in section
520(q)(1)(A)(ii) of the FD&C Act, OTC
hearing aids are ‘‘intended to be used by
adults age 18 and older to compensate
for perceived mild to moderate hearing
impairment.’’
Moreover, many comments urging
FDA to adopt lower limits than the ones
we are finalizing referred to material
that stated output levels in root mean
square (RMS) terms. The limits we are
finalizing are expressed differently—
expressed in terms of maximum peak
values (implicit in the measurement of
OSPL90 values). To derive a peak value
based on an RMS level, one would
increase the RMS level by an amount
that represents the ‘‘crest factor’’ of the
output. Thus, except in one
circumstance that is not applicable to
the materials submitted to us, RMS
values are lower than peak values for
the purposes of considering the sound
output of hearing aids, and comparisons
between RMS and peak values need to
take this difference into account.9
As noted, we are also finalizing a
lower limit for OTC hearing aids with
input-controlled compression activated.
This value, 117 dB SPL, is intended to
maximize the available headroom for
OTC hearing aids while still providing
reasonable assurance of safety and
effectiveness. As we explained in the
proposal, input-controlled compression
is an automatic function that
dynamically reduces the device’s output
and helps prevent the device from
continuously performing at its output
limit (see 86 FR 58150 at 58161–58162).
In these ways, the use of inputcontrolled compression adequately
addresses the safety concerns that the
increased output can raise. We explain
our reasons for finalizing lower output
limits in more detail below.
9 For square wave signals, the peak and RMS
values would be the same (a 0-dB difference).
However, for the purposes of describing hearing aid
performance, a crest factor would be an important
element for considering limits as RMS values, for
example, to ensure a limit expressed as an RMS
value allowed for effective amplification of speech.
Crest factors for speech are often 12–17 dB, with 15
dB being a value frequently cited in comments.
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We wish to emphasize that, in
finalizing lower output limits, we do not
intend to reduce the number of intended
users for whom the use of OTC hearing
aids is safe and effective (in comparison
to the proposed limits). Rather, we are
lowering final limits to allow sufficient
headroom for the same intended users,
albeit less headroom than we proposed.
As stated above, the output limits that
we are finalizing are intended to balance
safety and effectiveness without unduly
sacrificing either.
In response to comments, we are also
revising the final regulation to permit
the use of alternative acoustic couplers
when a 2-cubic centimeter (cm3)
coupler is not compatible with the
device design. See the response to
Comment 81 for more on this topic.
Additionally, we are slightly
modifying the phrasing of the regulation
to clarify that the device may reach the
higher limit only while the inputcontrolled compression is activated. For
example, if a user were to deactivate the
feature, the device must not exceed the
general output limit of 111 dB SPL
while the feature is deactivated.
2. Considerations for Appropriateness of
Output Limits
In deciding to finalize lower output
limits, FDA is primarily considering
output limits that will provide
reasonable assurance of safety and
effectiveness and are ‘‘appropriate’’ for
OTC hearing aids as section 709(b)(2)(B)
of FDARA uses the term. To determine
such limits, we are balancing
considerations of safety and
effectiveness for all intended users of
these devices to both protect and
promote the public health. As we
explained in the proposed rule, too high
of an output can be unsafe (see 86 FR
58150 at 58161). However, too low of an
output reduces device effectiveness and
can lead to poor device performance,
and ultimately, can reduce satisfaction
and use (see 86 FR 58150 at 58161).
Many comments described the
communication needs of hearing aid
users and how those interests relate to
the output limits and the purposes of
establishing the OTC category of hearing
aids. FDA agrees that those interests are
relevant to safety and effectiveness as
well as what would be appropriate.
However, balancing the various
considerations related to safety and
effectiveness is complex and involves
the application of scientific judgment.
Thus, while FDA agrees with the many
thoughtful comments that several
factors, discussed further in this section,
affect the determination of appropriate
output limits, we do not always agree
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with the determination reached by
commenters.
One of the purposes of this
rulemaking is to address a widespread
public health need stemming from
relatively low adoption and use of
hearing aids by people who could
benefit from them. More specifically, an
underlying goal of this rulemaking is
broadening access to these devices,
without the involvement of a licensed
person, to compensate for perceived
mild to moderate hearing impairment in
adults. (See the responses to Comments
10–12 for more about the scope of this
rulemaking.) FDA is mindful of the need
to establish or adopt output limits that
would provide sufficient amplification
to meet the user’s listening needs and
thereby bolster user satisfaction,
adoption, and use. Moreover, OTC
hearing aids need a sufficient output,
maximizing the available dynamic range
(the headroom), to meet the hearing
needs of the breadth of the intended
population of adults with perceived
mild to moderate hearing impairment.
Therefore, the output limits must not be
too low.
The appropriateness of output limits
for OTC hearing aids should also
account for circumstances in which
users must determine for themselves
when amplification may be excessive
and then potentially take action to
mitigate or avoid the situation, without
the involvement of a licensed person for
training or intervention. We are aware
that some users of hearing aids who
have perceived mild to moderate
impairment may have difficulties with
such tasks. For example, they may have
reduced dexterity or may have difficulty
judging their listening environments.
Thus, we are also mindful of the need
to establish or adopt output limits that
provide for reasonable assurance of
safety and effectiveness for such users
and others. Therefore, the output limits
must not be too high. (See also the
response to Comment 100 regarding the
use of consensus standards.)
FDA has considered quantitative
information to inform our consideration
of safety and effectiveness. In the
proposed rule, we referred to a national
workplace safety guideline,
‘‘Occupational Noise Exposure,’’
developed by the National Institute for
Occupational Safety and Health
(NIOSH) (see 86 FR 58150 at 58161–62)
(Ref. 9). That guideline, which we will
refer to as NIOSH–98, defines, among
other subjects, hazardous levels of
sound exposure in relation to the
duration of exposure. It uses as its basis
85 dBA (A-weighted decibels) over 8
hours (as in, a generic workday) as the
maximum non-hazardous exposure
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level (see paragraph 1.1 of NIOSH–98).
Roughly speaking, the difference
between A-weighted decibels and
decibels of sound pressure level, for
present purposes, is about 5 dB. As
such, 120 dB SPL, or about 115 dBA, of
exposure over 28 seconds would be
equivalent to a full workday’s allowable
exposure for purposes of occupational
safety (see table 1–1 of NIOSH–98). To
address different levels of exposure
besides 85 dBA, NIOSH–98 uses a 3-dB
exchange rate (or equal-energy rule),
meaning that the allowable time before
the exposure is considered hazardous
halves for every 3-dB increase (see
paragraph 1.1.2 of NIOSH–98). In other
words, for louder exposures, NIOSH–98
indicates less allowable time than 8
hours and vice versa for lower
exposures.
We have applied an equal-energy
principle and used a 3-dB exchange rate
as a basis for revising the output limits.
This interval, rather than another
amount, more clearly reflects our
consideration of non-hazardous outputs
and the differing output levels. Thus,
117 dB SPL, which is 3 dB less than
proposed, represents half the output
power of the proposal or twice the time
to achieve the same cumulative
exposure (when the hearing aid is
outputting at the limit). This translates
to a lower risk of impairment from using
OTC hearing aids. However, half the
allowable power does not mean the
output will sound ‘‘half as loud.’’ As
such, not only does 117 dB SPL
translate to a lower risk, it also does not
unduly sacrifice effectiveness.
For the purpose of illustration, you
might think of a person as having a
‘‘budget’’ of allowable sound exposure
from a hearing aid to avoid further
hearing impairment. The rate at which
the person goes through the budget
depends on the output level, and higher
outputs (which have higher power) will
use up the budget faster than lower
outputs. In other words, because
outputs at 117 dB SPL are half the
power of those at 120 dB SPL, 117 dB
SPL will use up the sound budget more
slowly. If a hearing aid user encounters
a sound at 117 dB SPL while using
hearing aids, the user will thus have
more of the budget left over to continue
wearing the hearing aid for the rest of
the day (without over-exposure) than if
the loud sound were at 120 dB SPL.
Note, however, that this analogy is
merely an illustration of some concepts
of cumulative exposure. Hearing
healthcare professionals use more
technical and precise concepts to
describe the effects of sound exposure
on hearing abilities.
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FDA notes that nothing in this
rulemaking is intended to interpret the
application of NIOSH–98 for purposes
of occupational exposure. Rather, we are
considering the effects of cumulative
and ongoing exposure in relation to
equivalent peak output levels for the
purposes of this rulemaking.
Conversely, we wish to clarify that
referring to NIOSH–98 does not mean
that hearing aids should offer an output
comparable to occupational noise
exposure. (The sound output of a
hearing aid is unlikely to reach its
output limit regularly.) Nonetheless,
NIOSH–98 provides a well-reasoned
quantitative approach to the effects of
sound exposure on people’s hearing.
While many comments agreed that
FDA’s proposed output limits provided
an adequate safety margin, other
comments disagreed and called our
attention to scenarios in which sound
exposure at a relatively high level might
be followed by continuing exposure at
a relatively modest level. In certain
circumstances, the equal-energy
principle would imply that the
relatively modest exposure could
nevertheless be hazardous. In the
proposed rule, we used the 3-dB
exchange rate to compare the
presumable reaction times between 120
dB SPL and 115 dB SPL, explaining that
the latter offers about triple the time, an
additional 61 seconds (approximately),
given the 5-dB difference (see 86 FR
58150 at 58161). This does not imply
that a continuous sound output of 115
dB SPL is safe for an extended period
of use of an OTC hearing aid. This also
does not imply that the user has
approximately 89 seconds to intervene
(for example, to remove the OTC
hearing aid). Experiencing these output
levels for long-enough periods of time
could place the user at greater risk for
further hearing impairment even though
the user might judge the follow-on
exposures to be modest or normal.
We acknowledge that the statement in
ANSI/CTA–2051:2017 that 115 dBA
(about 120 dB SPL) is an acceptable
listening level for up to 30 seconds
might imply that repeated exposures to
115 dBA (about 120 dB SPL) over the
course of a day’s use of a hearing aid are
necessarily acceptable as long as the
exposures are shorter than 30 seconds.
(Note that a day’s use of a hearing aid
may be longer or shorter than the
generic 8-hour workday that NIOSH–98
uses.) Further, we recognize that
referring to the full time as a safety
margin did not adequately account for
exposure to other sounds throughout the
day because using the entire 28-second
interval would equate to a day’s worth
of allowable cumulative exposure. The
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28-second interval assumes no other
sound exposure during that 8-hour
timeframe rather than continuing use
(and exposure) at a low-enough level. In
consideration of the comments,
especially those calling our attention to
possible scenarios leading to excess
cumulative exposure, we have
determined we should reduce the risks
of cumulative exposure and do so by
finalizing lower output limits than
proposed.
Nevertheless, FDA does not expect
OTC hearing aids to perform at or near
their maximum output capabilities for
extended periods of time during the
day, if at all. As such, neither our
reference to NIOSH–98 nor to ANSI/
CTA–2051:2017 should be read to imply
that constant outputs at or near 115 dB
SPL (about 110 dBA) are necessarily
safe. Instead, the limits we are finalizing
are meant to be high enough to allow
sufficient headroom for high-fidelity
amplification for people with perceived
mild to moderate hearing impairment,
including amplification of occasional
peaks necessary to reproduce certain
kinds of higher intensity, but infrequent,
sounds (see 86 FR 58150 at 58161–62).10
However, a device’s design or software
may have sufficient headroom without
reaching the maximum allowable
output. We intend these output limits to
facilitate wide adoption of hearing aids
and design flexibility without being
unnecessarily prescriptive.
Some comments recommended that
FDA adopt a requirement for dosimetry,
in essence applying similar principles
as those described in NIOSH–98. That
is, they suggested that FDA require that
OTC hearing aids be able to measure the
weekly sound exposure from the use of
the device. Instead of limiting peak
output, the devices could then limit
exposure to a safe cumulative dose.
While this approach may be one way to
limit exposure, insufficient scientific
data exist regarding cumulative
exposure with the use of hearing aids by
people with perceived mild to moderate
hearing impairment. Moreover, as we
noted above, this rulemaking and
NIOSH–98 contemplate very different
contexts, so the quantitative information
cannot be directly applied to
determining cumulative output limits
appropriate for OTC hearing aids. In
sum, FDA believes that establishing a
dosimetry-based limit for regulatory
purposes would be scientifically
premature at this time.
10 The maximum output for a person with greater
hearing impairment is likely to be higher than for
a person with less impairment; however, this
general rule is subject to considerable individual
variability.
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Indeed, quantitative analyses of safe
maximum output limits are generally
difficult to apply because the data do
not necessarily reflect regulatory
considerations. For example, they do
not fully reflect the intended users,
specifically users with perceived mild to
moderate hearing impairment, or other
considerations for reasonable assurance
of safety and effectiveness of OTC
hearing aids. Some sources use
audiometric threshold-based analyses to
quantitatively predict safe maximum
output limits (e.g., Ref. 10). However,
such analyses use criteria that FDA is
not adopting as they have the effect of
excluding some people for whom OTC
hearing aids would be appropriate.
Other references use threshold-based
analyses for the maximum output for a
hearing aid that is programmed using
existing professional fitting formulas,
applied to a database of audiograms
(e.g., Ref. 11). These results, however,
do not fully reflect the intended users of
OTC hearing aids, and interpreting the
results often involves the application of
criteria that FDA is not adopting, for
example, the choice and application of
threshold-based hearing loss categories.
In either case, these findings are
limited for identifying appropriate
output limits for OTC hearing aids
because this rulemaking is intended to
address perceived, not audiometrically
quantified, impairment. (See also the
response to Comment 24 regarding
measurements of hearing loss and
incorporating numerical thresholds into
this rulemaking.) Moreover, different
commenters interpreted the same
references differently, demonstrating
that even quantitative analyses leave
much to interpretation. Well-reasoned,
scientific views still exhibited
significant diversity. The analyses are
instructive, and we have updated our
risk assessment based in part on them,
but they cannot definitively settle the
regulatory questions of this rulemaking.
Hence, although we are finalizing lower
output limits based on the available
information, we are establishing the
limits at 111 and 117 dB SPL (peak, not
RMS, values) rather than the even lower
levels found or suggested in some of the
references submitted to us.
Other comments recommended FDA
adopt international standards developed
jointly by the WHO and the
International Telecommunication Union
(ITU). These comments identified ITU–
T H.870 (2018), ‘‘Guidelines for safe
listening devices/systems,’’ and ITU–T
H.871 (2019), ‘‘Safe listening guidelines
for personal sound amplifiers.’’
However, the guidelines refer to a WHOderived standard value for the
cumulative sound exposure for non-
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hearing-impaired adults. In other words,
they use a dosimetry-based method,
which we do not believe is a suitable
basis to establish an appropriate limit,
as explained above.
The guidelines do equate this to an
output value of 80 dBA for 40 hours per
week. However, the rationale
underlying the guidelines relies on
WHO thresholds and citations to
literature that, as explained, FDA is not
adopting and does not consider
definitive (see the response to Comment
24 about the WHO hearing loss
thresholds). Further, as even ITU–T
H.871 (2019) explains, Ref. 10 can be
read to suggest 90 dB SPL RMS as the
maximum sound output for persons
with normal hearing (see Appendix II of
ITU–T H.871 (2019)). Such maximum
sound output recommendations for
normal-hearing listeners cannot be used
to derive maximum output limits for a
hearing aid to compensate for perceived
mild to moderate hearing impairment.
Thus, FDA is declining to adopt this
cumulative exposure limit or the
equivalent peak output value.
The lack of sufficient data to establish
regulatory limits based on dosimetry
does not, however, mean that dosimetry
is not a useful feature. Manufacturers
that wish to include dosimetry-based
features in OTC hearing aids may do so.
Ultimately, as stated previously the
output limits that we are finalizing
reflect a balancing of safety and
effectiveness. By lowering the output
limit 3 dB SPL from the proposed rule,
these output limits result in a
meaningfully lower risk to the intended
users, without unduly sacrificing
effectiveness.
3. Applying Analyses to Real-World Use
of Hearing Aids
As we explain in the responses to
Comments 11 and 24, the perception of
hearing impairment is conceptually
integral to establishing the OTC category
of hearing aids, and the application of
audiometric thresholds to make
regulatory decisions is inconsistent with
how the hearing loss categories
themselves were formulated. Moreover,
audiometric threshold ranges or
databases of audiograms do not
necessarily reflect the needs and wants
of the intended users of OTC hearing
aids in a precise way. As such, while
quantitative analyses provide useful
information, including data on exposure
versus stability of hearing impairment,
the conclusions have inherent
limitations that militate against
adopting them wholesale for the
regulatory purposes of this rulemaking.
FDA also considered how hearing
health care providers fit hearing aids in
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a clinical environment. Ordinarily, a
fitting algorithm determines the
necessary amplification, including the
effective output limit of the device for
a given user. The provider would then
make further, iterative adjustments in
consultation with the hearing aid user.
These processes effectively guarantee
that the device’s output will rarely reach
the device’s maximum capability, if
ever.
However, OTC hearing aids may not
have features that prevent the user from
continuous access to the device’s
maximum output. Some comments
conveyed concerns that users, without
the aid of professional judgment, would
want to use unnecessarily high
amplification on a continual basis; they
would tend to prefer higher outputs
than a hearing healthcare professional
would set. In a worst-case example, the
volume control and other features could
cause maximum device amplification in
a loud environment, and the user does
not take action to mitigate the effects. In
such a worst-case scenario, the user
could suffer further impairment.
Although these comments used
anecdotes or more general concerns
based on professional experience to
support their views, we recognize that
hearing healthcare providers sometimes
recommend lower outputs than hearing
aid users might initially prefer. Thus,
while we would expect that a device
would seldom perform at its maximum,
much less continuously, even when set
at the applicable output limit, that
possibility is greater than for
professionally fit devices, for which the
audiologist or hearing instrument
specialist has, in effect, limited the
output. In further consideration of the
differences between professionally fit
and user-customizable devices, we find
additional indications that the safety
margin of the proposed output limits is
lower than we initially believed
regarding the risks of cumulative
exposure.
Several comments suggested that FDA
also reconsider users’ ability to react to
loud situations in which continued use
of an OTC hearing aid could present
significantly increased risks of injury
should the user not remove the hearing
aids or reduce the output. Some
comments observed that users of OTC
hearing aids are likely to have
characteristics not shared by the general
population. For example, OTC hearing
aid users may be more likely to have
reduced dexterity or experience
cognitive difficulties. Such
characteristics can hinder adjusting a
device in sufficient time, especially if
the controls are physically small or
require navigation (as in opening a
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software application on a smartphone to
navigate to the correct control interface).
Other comments noted that, while
obviously-loud sounds pose risks of
further hearing impairment, continuous
exposure to lower intensities can pose
such risks over a sufficiently long
period of device use. Under the
proposed limits, overexposure is
possible in scenarios where the device
is set to its maximum (providing the
maximum gain), yet the amplified
output does not discomfit the user
enough to mitigate the exposure. Such
a scenario would entail an increased
risk of impairment to residual hearing
from use of an OTC hearing aid.
The ability for users to act to protect
themselves was an important factor in
our proposed output limits (see 86 FR
58150 at 58162), and it remains so for
this final rule. FDA recognizes that
some OTC hearing aid users may need
more time or assistance to react to
noticeable overexposure than an average
member of the general population. The
required design and electroacoustic
performance features for OTC hearing
aids will significantly reduce such risks
for the intended users. For example, a
user-adjustable volume control will
allow a user to set and maintain the
device’s output below the maximum.
However, after considering the diversity
of scientific comments, we are
persuaded that our proposal did not
adequately account for cumulative
exposure to lower-intensity sounds
during daily use over an extended
period of time—on account of users’
ability or desire to intervene as well as
the other factors, explained above, that
might increase cumulative exposure and
the resulting risks. Since a dosimetrybased limit is impractical as discussed
above, we are lowering the allowable
maximum output to address
considerations of cumulative exposure.
4. Declining To Include Gain Limit
Multiple comments, many of which
urged FDA to establish or adopt a lower
output limit, recommended that FDA
also adopt a gain limit. These comments
contended that a gain limit would
improve device safety by further
reducing the risks of over-amplification,
primarily due to the device reaching its
gain limit and providing no further
amplification before it reached its
output limit (see 86 FR 58150 at 58162).
In effect, a gain limit would lower the
output limit.
FDA acknowledges that a gain limit
may play a role in the management of
risks from overamplification. However,
a gain limit reduces the ability to
adequately amplify soft sound inputs in
some cases, which can lead to decreased
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device effectiveness and user
satisfaction. Moreover, the appropriate
gain for a given device will depend on
device design and features. Imposing a
gain limit may constrain device design
and innovation, which could have an
undesirable effect on device benefit for
intended users.
In addition to preserving flexibility in
device design, FDA is not requiring a
gain limit in order to maximize access
to these devices for the full range of
intended users with perceived mild to
moderate hearing impairment. Intended
users of these devices are a
heterogenous population with a range of
hearing and communication difficulties
and needs. By not requiring a gain limit,
the broadest range of intended users
will have access to effective devices.
This flexibility empowers users to
customize their hearing aids to their
needs, listening preferences, and
communication goals, and it allows for
a wider range of options should users’
needs, preferences, and goals change
over time.
FDA is establishing requirements to
provide reasonable assurance of safety
and effectiveness of OTC hearing aids
for the intended user population, and
further reducing the device’s output by
establishing a gain limit is not necessary
for such reasonable assurance. Indeed, a
gain limit in this case may detract from
such reasonable assurance by broadly
reducing the available amplification for
the user and limiting the range of
intended users of the device. Because
the appropriate output limits we are
finalizing will sufficiently limit device
output, we are not finalizing a gain limit
that would further reduce the output.
(See also the response to Comment 78,
describing how frequency response
smoothness helps prevent under- and
overamplification of frequency bands, in
effect, a more-focused reduction than a
gain limit.) This also allows
manufacturers the flexibility to design
their devices to balance the required
output limits with the amplification
needs of the intended user population.
F. Other Device Requirements
(§ 800.30(e) and (f))
Several comments shared a concern
for an influx of unsafe or ineffective
devices to the marketplace, for example,
devices that do not satisfy the
requirements of the OTC Hearing Aid
Controls because of lax enforcement
and/or manufacturers or sellers evading
regulatory controls necessary for
reasonable assurance of safety and
effectiveness of OTC hearing aids. Such
comments tended to focus on the risks
to health of violative or non-conforming
products, for example, impairment of
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remaining hearing from excessive
device output, injury stemming from
inferior manufacturing practices, or
ineffective treatment resulting from the
possible difficulty of distinguishing an
OTC hearing aid from consumer
electronics not intended to compensate
for hearing loss.
To provide reasonable assurance of
safety and effectiveness of OTC hearing
aids, and thereby avoid an influx of
unsafe or ineffective devices, we are
establishing requirements for, among
other things, the design and
performance of OTC hearing aids. At the
same time, the requirements will not
unnecessarily constrain device design or
burden manufacturing, which could
hinder innovation or impede adoption
and use of the devices. Further,
compliance with regulatory controls is a
concern for all devices, and FDA
monitors the marketplace and conducts
regular inspections and other
postmarket surveillance as part of
maintaining reasonable assurance of
safety and effectiveness.
1. Electroacoustic Performance
(Comment 73) Some comments urged
FDA to adopt the same electroacoustic
performance requirements for
prescription hearing aids as those for
OTC hearing aids.
(Response) While FDA agrees that
prescription hearing aids should
provide high-fidelity amplification for
users, we do not agree that prescription
hearing aids should be subject to the
same electroacoustic performance
requirements as OTC hearing aids. The
requirements for OTC hearing aids will
provide reasonable assurance of safety
and effectiveness without the
involvement of a licensed person, such
as an audiologist or hearing instrument
specialist, to adjust the device output
and ensure it performs adequately.
However, the requirements we are
finalizing for prescription hearing aids
presume the involvement of a licensed
person: As prescription devices, they
may only be sold to or on the
prescription or other order of a
practitioner licensed by law to use or
order the use of the devices (see
§ 801.109(a)(2)).
The labeling requirements we are
finalizing for prescription hearing aids
include technical specifications that an
audiologist or hearing instrument
specialist can use to select and adjust
the hearing aid (see 86 FR 58150 at
58164). These requirements are virtually
identical to the long-standing labeling
requirements for hearing aids in former
§ 801.420(c)(4) upon which
professionals rely. Additionally, we are
finalizing a new requirement to state the
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latency of the prescription hearing aid,
measured with a method that is accurate
and repeatable to within 1.5 ms. This
information will be particularly useful
for fitters given evolving hearing aid
designs and sound processing
capabilities. However, we are not also
establishing a latency performance limit
for prescription hearing aids. The
aforementioned information and the
involvement of a licensed person will
provide reasonable assurance of safety
and effectiveness of prescription hearing
aids without the additional performance
requirements necessary for OTC hearing
aids.
(Comment 74) A comment
recommended that the requirements for
an OTC hearing aid sold by a licensed
person be no different than those for
sale by a non-licensed person, and that
the final rule should clearly state that
preemption would apply to this
situation.
(Response) To the extent that this
comment recommends that the
requirements for the OTC hearing aid
itself be no different when sold by a
licensed person, versus a non-licensed
person, FDA agrees with the comment.
The requirements for OTC hearing aids
themselves (output limits,
electroacoustic performance, labeling,
etc.) that we are finalizing apply equally
to those sold by licensed and nonlicensed persons. To the extent that this
comment recommends that State
regulation of the activities associated
with the sale of OTC hearing aids, for
example, via licensing requirements, be
preempted, we have addressed that
request along with similar comments in
the Preemption sections III.H and VIII.
(Comment 75) A comment suggested
that prescription hearing aids have the
same output limit as OTC hearing aids.
(Response) FDA does not agree that
prescription hearing aids should have
the same output limit as OTC hearing
aids because people with a more severe
degree of hearing loss than perceived
moderate impairment may need
additional gain, and therefore would
need a higher output, potentially above
limits appropriate for OTC hearing aids.
We recognize that people with more
severe hearing impairment can still
suffer further impairment of their
remaining hearing, so the device output
must not be too high for them. We are
finalizing a requirement, as proposed,
that labeling warn dispensers to exercise
special care when selecting and fitting
a hearing aid with an output that
exceeds 132 dB SPL. This warning is
nearly the same as the required warning
statement in former § 801.420(c)(2).
Nevertheless, the output necessary to
compensate for more severe hearing
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impairment safely and effectively,
though subject to individual variability,
will generally be higher than would be
permissible for OTC hearing aids.
(Comment 76) Comments suggested
that FDA require input-controlled
compression for all OTC hearing aids to
help significantly reduce the risk that
users could worsen their hearing
impairment by using an OTC hearing
aid.
(Response) FDA agrees that inputcontrolled compression can provide
multiple benefits for OTC hearing aid
users. For example, this feature allows
the device to adapt the output
dynamically, based on the listening
environment. This can reduce the user
interaction necessary to adjust the
device for different situations. Some
users find the feature improves the
hearing aid’s comfort, contributing to
their satisfaction and encouraging
continued use. This in turn can help
accomplish this rule’s purposes of
promoting wider adoption and use.
However, some users find the feature
annoying or distracting, reducing their
satisfaction and discouraging them from
using their hearing aids. Moreover, the
feature is not necessary for reasonable
assurance of safety or effectiveness
(when the device does not exceed an
output of 111 dB SPL). For these
reasons, FDA is not requiring inputcontrolled compression for all OTC
hearing aids. (See also the response to
Comment 77 about including noisecancelling technology.)
(Comment 77) A comment suggested
requiring that OTC hearing aids include
noise-cancelling technology to prevent a
loss of benefit from using the devices in
noisy environments.
(Response) FDA agrees that noisecancelling technology can help hearing
aid users in certain situations. For
example, the feature can help improve
the clarity of voices by reducing the
volume of only background noise. This
can reduce the user interaction
necessary to adjust the device for
different situations. However, the
feature is not generally necessary for
reasonable assurance of safety or
effectiveness because air-conduction
hearing aids can still provide adequate
amplification to achieve effectiveness
without the feature, so FDA is not
requiring noise-cancelling technology
for all OTC hearing aids. (See also the
response to Comment 76 about
including input-controlled
compression.)
(Comment 78) Comments requested
that FDA remove the frequency
response smoothness requirements so,
these comments asserted, OTC hearing
aids would accommodate all kinds of
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perceived mild to moderate hearing
impairment, not just individuals with
typical age-related, sloping hearing
impairment.
(Response) Although FDA agrees that
OTC hearing aids should be safe and
effective for the breadth of the intended
user population with perceived mild to
moderate hearing impairments, we are
not removing the frequency response
smoothness requirements for OTC
hearing aids. As we explained in the
proposed rule, a smooth frequency
response will ensure that an OTC
hearing aid does not under- or
overamplify certain sounds (see 86 FR
58150 at 58164). A device that does not
have a smooth frequency response can,
for example, perceptibly distort speech
quality (see 86 FR 58150 at 58164).
Moreover, the proposed frequency
response smoothness requirements do
not limit device output to compensating
only for typical age-related, gradually
sloping hearing impairment. More
specifically, the frequency response
smoothness describes the flatness of the
output when the device is set to provide
constant gain as a function of frequency,
that is, when the device is not set to
provide frequency shaping. The idea is
that the flatter the response when the
device is not set to provide frequency
shaping, the more consistently the
device will achieve any intended
frequency shaping to accommodate the
user’s customization, for example, to
compensate for a sloping hearing loss.
This is similar to how a loudspeaker’s
frequency response is later adjusted by
an equalizer, which shapes the input
signal. In short, frequency response
smoothness does not prevent the device
from appropriately amplifying lower
frequencies. Instead, it helps prevent
under- and overamplification at any
frequency band that could result from a
device that does not appropriately shape
the output. We are finalizing the
smoothness requirements as proposed.
(Comment 79) Some comments
proposed that OTC hearing aids have
cutoff limits: if the output were to
exceed certain thresholds for a longenough time, the device would reduce
or stop amplification, even if the device
never exceeded the allowable output
limit.
(Response) FDA agrees that an OTC
hearing aid user could experience overamplification even if the device does
not exceed the allowable output limit.
As we explain in section V.E of this
document, we have considered this
possibility further and are
correspondingly finalizing output limits
lower than we proposed. We also
explain in that section that insufficient
data exist to establish regulatory limits
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for exposure over time based on
dosimetry. As with implementing
dosimetry-based features, manufacturers
may establish cutoff limits for their
devices, but FDA is not requiring such
features for OTC hearing aids.
(Comment 80) A comment requested
that FDA allow greater latency for OTC
hearing aids, suggesting 25 milliseconds
(ms). The comment argued that this
delay would still not be perceptible to
the user. Other comments requested that
FDA address latency for wireless
streaming technologies, such as
Bluetooth, and other hearing aid
designs.
(Response) FDA does not agree that
allowing greater latency will be
imperceptible. One comment cited for
support material that showed four out of
nine people perceived a delay of 25 ms.
(Two out of nine perceived it at 15 ms.)
This does not suggest that allowing
greater latency will be equally
imperceptible, though such a small
sample may not have yielded
generalizable results. Regardless, human
hearing perception can be sensitive to
differences longer than 15 ms,
depending on frequencies and
conditions, and signal processors for
hearing aids can reliably achieve
latencies shorter than 15 ms. Given
these considerations, we do not agree
that greater latency will be
imperceptible or that a limit of 15 ms
unduly constrains device design. FDA is
not revising the latency limit for OTC
hearing aids.
Regarding wireless streaming
technologies, the latency limit we are
finalizing is an electroacoustic
performance metric that describes how
quickly an OTC hearing aid must
produce the output sound relative to the
input sound, that is, the acoustic input
(see 86 FR 58150 at 58164). It does not
describe the time necessary for an OTC
hearing aid to receive and process a
wireless signal after transmission,
which can often exceed 15 ms, even
under ideal conditions. In contrast to
electroacoustic performance, FDA has
not determined that a wireless
transmission latency limit is generally
necessary for reasonable assurance of
safety and effectiveness of OTC hearing
aids because air-conduction hearing
aids compensate for impaired hearing
primarily by detecting sounds with onboard microphones. As such, wireless
streaming latency does not generally
raise the same perceptual concerns as
electroacoustic latency. Therefore, we
are not establishing a wireless
transmission latency limit. (See also the
response to Comment 64 regarding
labeling for wireless streaming latency.)
However, there may be circumstances
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where, based on the device’s design,
wireless streaming latency does raise
the same perceptual concerns as
electroacoustic latency. In such
circumstances, manufacturers will
likely need to consider wireless
transmission latency for devices that
incorporate such technology.
As for different device designs
regarding acoustic transmission, the
latency limit applies. For example,
‘‘open-fit’’ devices that allow some
incoming sound to bypass the hearing
aid would also need to respect the
latency limit. Moreover, the latency
limit is a performance baseline.
Manufacturers may design devices with
lower latency should they want to
improve electroacoustic performance.
(Comment 81) Some comments
suggested that FDA permit different
acoustic couplers than proposed for the
electroacoustic performance testing
requirements. These comments argued
that standard 2-cm3 couplers would not
be the most appropriate for some device
designs, and performance measurements
would more accurately reflect device
capabilities if more suitable couplers
were permitted.
(Response) FDA agrees that 2-cm3
couplers may not be compatible with
some device designs. We are revising
the final regulations to permit use of
alternative acoustic couplers that are
compatible with the device. The
manufacturer would have to document
how use of the alternative approach is
scientifically valid and technically
equivalent.
(Comment 82) A comment requested
that FDA prescribe the method to test
latency beyond requiring that
measurements be accurate and
repeatable to within 1.5 ms.
(Response) Although FDA is
finalizing standardized test methods to
ensure other electroacoustic
specifications are comparable across
devices, the comparability of latency is
less sensitive to the specific method.
Latency is a measurement of time, so
essentially any scientifically suitable
and accurate timing method will
produce a result that is comparable to
other suitable and accurate methods,
even though the methods may differ in
the specifics. As such, we are specifying
how accurate the timing must be but
allowing flexibility for the specific
method. Nevertheless, clause 4.8 of
ANSI/CTA–2051:2017 suggests two
different methods, either of which is
acceptable provided the testing
equipment is sufficiently accurate and
precise.
(Comment 83) A comment observed
that FDA considered the electroacoustic
performance requirements in ANSI/
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CTA–2051:2017, including the selfgenerated noise limit. However, FDA
did not specify A-weighted
measurements for the self-generated
noise limit in the proposed regulation as
the standard does. The comment
suggested FDA specify A weighting
consistent with the standard.
(Response) FDA agrees that A
weighting is more consistent with the
standard. We are revising the selfgenerated noise limit in the final
regulation to refer to A-weighted
decibels.
2. Design Requirements To Ensure
Proper Physical Fit and Prevent User
Injury
(Comment 84) Several comments
urged FDA to hold OTC hearing aids to
the same hardware standards as
prescription hearing aids. Some of these
comments focused on Quality System
requirements (see Comment 95 and our
response). Others focused on equivalent
electroacoustic performance.
(Response) FDA agrees that OTC and
prescription hearing aids should both be
held to standards appropriate for
medical devices. However, we are not
applying all of the same specific rules
to both because OTC and prescription
hearing aids differ in important
respects, for example, the intended uses.
Some of the same rules will apply to
both. As we explain in the response to
Comment 95, OTC hearing aids will be
subject to quality management system
requirements that are appropriate for
medical devices. The same will be true
for prescription hearing aids. Thus, both
OTC and prescription hearing aid
manufacturers will need to comply with
the same Quality System requirements
under part 820, even if their individual
implementations differ in the details.
(See also the response to Comment 96
about a risk-based approach to quality
management systems.)
However, some of the requirements
will differ, such as those for device
performance. We explain in the
responses to Comments 73 and 75 that
OTC and prescription hearing aids have
different intended uses, and therefore,
they must satisfy different performance
needs. Thus, having reasonable
assurance of safety and effectiveness of
both categories of hearing aids entails
different specific requirements for each
category.
(Comment 85) Some comments
proposed requiring that eartips for OTC
hearing aids be made of ‘‘medical
grade’’ materials to prevent irritation or
damage from the components of the
device in contact with the ear canal.
(Response) FDA agrees that contact
with substances can cause adverse
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tissue reactions like skin irritation;
however, the design requirements that
we are finalizing for OTC hearing aids,
along with existing requirements and
policies, are sufficient to address the
kinds of materials used.
The design requirements that we are
finalizing for OTC hearing aids include
a requirement that the material for the
eartip be atraumatic, which is the same
as proposed. As explained in the
proposal, atraumatic materials are those
that prevent injuries to the skin and
bone, and the use of atraumatic
materials reduces the chance that daily
use or accidental contacts will cause
damage to the delicate skin or bone of
the ear (86 FR 58150 at 58165). In
evaluating the material for the eartip to
determine whether it meets this
requirement, manufacturers may wish to
review FDA’s guidance, ‘‘Use of
International Standard ISO 10993–1,
‘Biological evaluation of medical
devices—Part 1: Evaluation and testing
within a risk management process,’ ’’
issued September 4, 2020, which
describes FDA’s approach to
biocompatibility evaluation of medical
devices, including considerations and
recommendations for manufacturers.11
As described in the aforementioned
guidance, OTC hearing aids (depending
on the specific device) would likely be
a surface device in contact with intact
skin. As such, manufacturers should
consider the specific biological effects of
cytotoxicity (toxic effects on cells),
sensitization (becoming more sensitive
to materials over time), and irritation or
intracutaneous reactivity (a reaction
within the layers of the skin). The use
of certain common materials in surface
devices contacting intact skin may help
manufacturers to pursue leastburdensome methods for evaluating
biocompatibility.
Additionally, as we explain in the
responses to Comments 95, 96, and 97,
OTC hearing aids will be subject to the
Quality System requirements, which
will also help provide for reasonable
assurance of safety and effectiveness.
(Comment 86) Several comments
suggested requiring that OTC hearing
aids use non-proprietary designs and/or
open-platform technology because, in
the commenters’ views, proprietary
designs or closed platforms would limit
the compatibility of accessories,
availability of replacement parts, or
possibility of modifications to the
devices.
11 The document is available online at: https://
www.fda.gov/regulatory-information/search-fdaguidance-documents/use-international-standardiso-10993-1-biological-evaluation-medical-devicespart-1-evaluation-and.
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Other, similar comments proposed
that OTC hearing aids have a standard
user interface or support a standard
application programming interface (API)
to allow users to access and modify
device settings, perhaps through thirdparty software, when the manufacturer
has not exposed the desired settings to
user control. Some comments identified
a standard API (or some other standard
protocol) as a way to enable device
interaction with other electronics of the
user’s choosing, for example, a
smartphone from a different
manufacturer.
(Response) While some OTC hearing
aid users may desire such features, we
do not currently consider them
necessary for reasonable assurance of
safety and effectiveness of OTC hearing
aids generally. Hearing aids that
incorporate proprietary designs and
interfaces can be safe and effective,
without interaction with third-party
products. Manufacturers may
implement open features, but we are not
requiring them.
(Comment 87) Several comments
suggested that all OTC hearing aids have
a user-adjustable volume control
because the feature would be integral to
device safety regardless of its output
limit. A comment suggested that all
hearing aids should have a volume
control built into the device itself,
separate from a software controller (as
in, a ‘‘slider’’ in a smartphone
application, for example).
(Response) FDA agrees that a useradjustable volume control should be a
design feature of all OTC hearing aids,
and we are finalizing such a
requirement under new § 800.30(f)(5).
However, although FDA understands
that a physical (that is, built into the
device itself) volume control could
provide ready access for some users to
adjust the volume, we are declining to
adopt this suggestion.
While some users may find a physical
volume control useful, several
comments that FDA received observed
that many users of OTC hearing aids
may have limited dexterity, which
would in turn limit the usefulness of a
hardware controller, for example, a
small dial or push buttons on the
device. Similarly, we received
comments emphasizing hearing aid
users’ desire for a discreet device,
including both its form and its
operation. A user interface, perhaps
implemented on a remote control or a
mobile device, will allow design
flexibility for manufacturers to develop
and market smaller hearing aids, and
adjusting the volume through such an
interface may feel more discreet for
many users than reaching up to the
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device to adjust it, perhaps needing
additional effort to manipulate
physically small controls.
This is consistent with the many
comments we received urging that we
require the devices to have wireless
controls. (See the response to Comment
94 for further discussion on this topic.)
For people who are less inclined to use
software, they may still purchase a
device with a physical volume control
or, alternatively, they may still
manually limit the sound exposure by,
for example, removing the device,
covering the microphone, or seeking a
quieter environment.
(Comment 88) A comment suggested
that all OTC hearing aids have an option
for volume limitation and a parental
volume control.
(Response) FDA is not adopting these
suggestions because the output limits
we are finalizing will provide
reasonable assurance of safety and
effectiveness without requiring an
additional feature that would limit the
output further. (See also section V.E.4 of
this document explaining why FDA is
not establishing a separate gain limit.)
However, we are finalizing a
requirement that all OTC hearing aids
have a user-adjustable volume control
(see the response to Comment 87).
A parental volume control is likewise
not necessary for reasonable assurance
of safety and effectiveness, including
cases in which the caregiver is not the
user’s parent. Moreover, establishing a
requirement for ‘‘parental control’’ may
imply that the devices are intended for
people younger than 18, which is not
the case for OTC hearing aids (see 21
U.S.C. 360j(q)(1)(A)(ii)).
(Comment 89) A comment proposed
that the user-adjustable volume control
must allow for at least 6 dB of potential
adjustment to the device output to
‘‘ensure perceptual functionality.’’ This
amount, the comment asserted, would
help significantly reduce the risk that
users could worsen their hearing
impairment by using an OTC hearing
aid. Other similar comments suggested
that FDA specify the performance
requirements for the volume control in
terms of the range.
(Response) FDA is not requiring that
a user-adjustable volume control adjust
the volume in 6-dB increments at a
minimum, and FDA is not specifying
the range for the volume control.
The comment proposing 6-dB
increments asserted that a 3-dB change
in signal intensity is the average needed
for users to perceive a volume
difference, thus a 6-dB increment would
ensure that users perceive it. However,
FDA expects that users will manipulate
the control until they perceive not only
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a difference but a satisfactory output
volume, regardless of the size of the
increment. Further, a 6-dB minimum
increment may force users to increase
the volume more than desired,
providing unnecessarily high
amplification while constraining device
design and performance. FDA does not
agree that a minimum volume
adjustment increment of 6 dB will
appreciably reduce risks or increase
effectiveness.
As for the range over which the
volume control must operate, a
specification is not necessary for
reasonable assurance of safety or
effectiveness, and it may constrain
device design unnecessarily. The output
of an OTC hearing aid may not exceed
the applicable limit under final
§ 800.30(d) regardless of the
performance of the volume control, so
establishing an upper limit would be
redundant. As for a lower limit, a
specific minimum setting would
generally depend on the device design.
Thus, for similar reasons to not
requiring a minimum increment, we are
not requiring a minimum volume
setting.
(Comment 90) Comments suggested
establishing an absolute limit on the
maximum insertion depth for OTC
hearing aids. There was variability in
the range of recommended insertion
depth limit ranging from 7.5 mm to 21
mm, though the most frequent
recommendation was 15 mm to 17 mm.
(Response) FDA agrees that a fixed
limit on the insertion depth of an OTC
hearing aid is a better measurement than
the anatomical landmark that we
proposed (the bony cartilaginous
junction). We are finalizing a fixed
insertion depth limit relative to the
expected distance from the eardrum
(tympanic membrane). Note that a
‘‘fixed insertion depth limit’’ means a
limit that is a specific distance
measurement rather than a more relative
description. This meaning is different
from describing a hearing aid as ‘‘fixed
length’’ (or similar) in reference to a
hearing aid that does not change length.
FDA did not propose and is not
finalizing a design requirement that
hearing aids have a fixed length.
As we explained in the proposal, the
length of the ear canal can vary greatly
among adults (see 86 FR 58150 at
58165). A fixed insertion depth limit
may be too deep for some individuals,
potentially resulting in injury.
Comments noted that a hearing aid
inserted too deeply in the ear canal can
cause increased sound pressure levels to
be delivered to the eardrum as well as
push earwax deeper into the ear canal.
However, the same fixed depth limit
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may be too short for others, potentially
reducing device effectiveness. As
comments recognized, the hearing aid
must be inserted deeply enough for it to
stay in place despite jaw movement, and
deeper insertion also helps with
reducing acoustic feedback and
improving gain (amplification).
Moreover, deeper insertion can help
reduce the cosmetic impact of the
hearing aid, that is, help it to be less
visible, which may reduce selfconsciousness or perceptions of stigma
from wearing the device.
Furthermore, we are not aware of any
widely accepted method to describe the
measurement of the insertion depth of
hearing aids. Ear canal anatomy varies
across individuals, and methods may
not agree on exactly where to start the
measurement for various OTC hearing
aid designs. These factors may lead to
significantly different measurements of
insertion depth for the same device.
We proposed a limit based on an
anatomical landmark, and several
comments characterized the proposal as
insufficiently defined and subject to
significant variability across
individuals. While measurements
relative to the individual’s anatomy
would be ideal, we recognize it is not
currently practical, considering the
uncertainties stemming from anatomical
variability and insertion depth
measurement.
As such, following review of all
relevant comments, we have determined
a limit defined by the distance of the
innermost (that is, most medial)
component of the hearing aid relative to
the eardrum. This should be a generally
understandable and consistently
measurable way to ensure safe design of
the device with respect to placement in
the ear canal. Thus, we are limiting the
insertion depth to a specific expected
distance (‘‘setback’’) from the eardrum
(tympanic membrane): 10 mm from the
innermost component of the device to
the eardrum. In establishing this limit,
we considered that its primary purpose
is to minimize the risk of injury to the
tympanic membrane and the skin of the
bony portion of the ear canal. We
believe that an OTC hearing aid
designed to have a 10-mm setback will
minimize the risk of injury from
inserting the device too deeply while
allowing for individual anatomic
variability, but without unduly limiting
effectiveness.
For adults, the average length of the
ear canal has been estimated to be 23–
28 mm (Refs. 12 and 13). Using an
average length of 25 mm, manufacturers
may generally assume that the
maximum insertion depth of a hearing
aid designed with a setback of 10 mm
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from the tympanic membrane would be
approximately 15 mm. We acknowledge
that an OTC hearing aid design based on
this setback limit may result in an actual
setback of somewhat less than 10 mm in
users with shorter than average ear
canals. However, we believe that the
limit is conservative enough to ensure
safety even in these cases. Some
comments pointed out that receiver-inthe-canal hearing aids can have
insertion depths of 20–21 mm.
However, an audiologist or hearing
instrument specialist typically fits such
a device. We do not currently consider
such insertion depths to be appropriate
for OTC hearing aids.
(Comment 91) Some comments
proposed either encouraging or
requiring that OTC hearing aids use
only instant-fit eartips or customized
eartips, fabricated based on noninvasive ear scans, to couple the device
to the ear canal. A few of these
comments further suggested that FDA
require a licensed person to fabricate
custom earmolds or ear shells.
(Response) FDA is not requiring the
use of instant-fit eartips or eartips
fabricated based on non-invasive ear
scans because currently classified
devices to create earmolds and ear
shells are not intended for the user of
the OTC hearing aid. Instead, earmolds
and ear shells are intended for use by
a hearing health professional because
they often require an impression-making
procedure. As some comments noted,
improperly taking the impression can
leave behind impression material or
injure the ear. Separately requiring
instant-fit (or non-invasively created)
eartips is unnecessary for reasonable
assurance of safety and effectiveness of
OTC hearing aids.
However, a manufacturer may design
an OTC hearing aid intended to be
compatible with custom earmolds or ear
shells, that is, the use of such is optional
but not necessary. (A device intended to
rely on taking impressions would imply
the need for a licensed person, hence
the device would not be ‘‘available’’
over the counter.) We do not wish to
preclude this possibility, nor do we
wish to limit the kinds of eartips in the
future that may be safe and effective for
users of OTC hearing aids. Considering
the current regulatory framework and a
desire to avoid unduly constraining
design, we are not adopting this
suggestion.
(Comment 92) A comment suggested
that OTC hearing aids with removable
eartips must have a specific minimum
amount of force to remove the eartips
from the device. The comment asserted
this would help prevent an eartip from
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falling off the device and lodging in the
ear canal.
(Response) FDA is not requiring that
eartips have a minimum force to detach
them from the device because
determining a generally applicable
threshold would be impractical and
unnecessary. The force exerted on an
eartip during normal removal or wear
may vary depending on the device
design, materials, and the user’s
anatomy, among other factors.
Furthermore, any minimum force
requirement would need to ensure that
the force was not so great as to hinder
the ability of users to change eartips,
particularly for users who have limited
dexterity. However, we note that
manufacturers of devices with
removable eartips should consider the
risks of accidental separation of an
eartip within the canal and ensure their
specific designs prevent such adverse
events. Although we are not establishing
a threshold for force that would apply
to all OTC hearing aids, manufacturers
should incorporate robust device
designs that help provide for safe and
effective hearing aids.
(Comment 93) Comments suggested
that FDA require a self-administered
hearing test to accompany OTC hearing
aids because users are not always able
to determine whether their hearing loss
is mild or moderate.
(Response) While a self-administered
hearing test may be one way for users
to control OTC hearing aids and
customize the devices to their hearing
needs, we are not requiring that selfadministered hearing tests accompany
OTC hearing aids. In some cases, a test
is not necessary to achieve safe and
effective amplification to compensate
for perceived mild to moderate hearing
impairment. For example, a self-fitting
strategy could do so by guiding the user
through a setup process that is not a
diagnostic hearing test. Further, users
may wish to obtain a hearing test by
some other means, for example, by
voluntarily visiting an audiologist. The
inclusion of a hearing test with the
device, in either case, would be
unnecessary. Manufacturers may decide
to incorporate a validated diagnostic
function as appropriate for their device
designs, but we do not agree that it
should be a requirement for all OTC
hearing aids.
(Comment 94) A comment suggested
requiring that OTC hearing aids
integrate Bluetooth or telecoil
technology so users can configure the
devices with their smartphones.
(Response) While Bluetooth or other
wireless technologies may be desirable
for some users of OTC hearing aids, we
are not requiring such functionality. We
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acknowledge that, by definition, a
wireless hearing aid will incorporate
wireless technology in its programming
or use, and we would expect that, with
current technologies, most OTC hearing
aids will incorporate wireless.
However, we also expect that wireless
technology will continue to evolve, and
specifying protocols or capabilities may
unnecessarily constrain design and
hinder innovation. For example, telecoil
technology may currently be practical
for relatively larger form factor devices,
but users may not desire the
functionality or the size necessary to
incorporate a telecoil, for example, if
preferring a smaller device. Other
methods of connectivity may also
develop, and such devices may be
appropriate for OTC availability despite
lacking wireless technology. In sum,
requiring such features could
potentially increase cost while
hindering innovation and reducing
adoption and use of OTC hearing aids.
(See also the response to Comment 87
about requiring a physical control for
volume adjustment.)
3. Quality System Requirements
In the proposal, we sought input on
the Quality System requirements that
would apply to OTC hearing aids but
also explained that any changes to the
Quality System requirements would be
proposed in a separate rulemaking
proceeding (86 FR 58150 at 58165).
Below we summarize the input that we
received and respond to it.
(Comment 95) Many comments
supported FDA’s proposal that all
applicable Quality System requirements
under part 820 remain in force for the
manufacture of OTC hearing aids. Most
of these comments emphasized that
hearing aids are medical devices and, as
such, should be subject to
commensurate manufacturing
requirements. Most such comments also
opined that the current requirements are
not unduly burdensome or
unreasonably costly, and in fact, can aid
device development. For example, as
one such comment stated, the
application of Quality System
requirements helps manufacturers to
identify risks and problems early,
helping to focus resources on the most
promising new ideas. Such
requirements allow manufacturers to
identify what works well and effectively
investigate what does not. The
requirements collectively help reduce
costs and time to market.
(Response) We have further
considered the applicability of Quality
System requirements under part 820,
and we are not modifying the
applicability of the requirements for
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OTC hearing aids. The device quality
system requirements are part of the
general controls for all devices that help
provide for reasonable assurance of
safety and effectiveness. In the proposal,
we explained that we had previously
received conflicting feedback on the
possibilities but that we believed a
quality management system specific to
medical devices was appropriate (see 86
FR 58150 at 58165). Moreover, we
consider the Quality System
requirements to be interdependent yet
inherently flexible (see 86 FR 58150 at
58165). We continue to hold these
views, and although we again received
conflicting comments, we agree that the
requirements are not unduly
burdensome. (See also the response to
Comment 96, explaining the risk-based
nature of the Quality System
requirements and the revisions FDA is
proposing in a separate rulemaking.)
(Comment 96) A comment proposed
that the extent of Quality System
controls be based on the risks of device
use and the complexity of the device. It
suggested that manufacturers be allowed
to maintain a Declaration of Conformity,
along with supporting documentation,
that the manufacturer could provide to
FDA upon request.
(Response) As we explained in the
proposed rule, the Quality System
requirements under part 820 are
inherently flexible (see 86 FR 58150 at
58165). We have elsewhere explained
that one of the purposes of the
flexibility is to allow manufacturers to
develop and follow procedures and
processes that are appropriate to a given
device and according to the state of the
art for designing and manufacturing that
device (see 87 FR 10119 at 10121,
February 23, 2022). Moreover, FDA is
proposing to harmonize part 820 with
an international consensus standard,
International Organization for
Standardization (ISO) 13485:2016,
‘‘Medical devices—Quality management
systems—Requirements for regulatory
purposes,’’ that has an even more
flexible approach to quality based on
risk management (see 87 FR 10119 at
10122). Thus, although FDA agrees that
Quality System controls should be
based in part on the risks of device use,
we are not modifying this final rule
because the requirements are already
flexible and risk-based, and we are
elsewhere proposing to harmonize the
risk-based approach with a yet more
flexible international consensus
standard.
Regarding the use of Declarations of
Conformity, section 514(c)(1)(A) of the
FD&C Act provides that a person may
submit a Declaration of Conformity to
an FDA-recognized consensus standard
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to meet a requirement under the FD&C
Act (see 21 U.S.C. 360d(c)(1)(A)). If a
person elects to use a Declaration of
Conformity in such a way, the person
must provide a Declaration of
Conformity certifying that the device in
question is in conformity with an FDArecognized consensus standard (see 21
U.S.C. 360d(c)(1)(B)). That is,
Declarations of Conformity appertain to
devices themselves; to declare that a
device is in conformity to a standard for
a quality management system is not
equivalent to declaring that the quality
management system itself conforms to
the standard. For more information on
using Declarations of Conformity, you
may wish to refer to FDA’s guidance,
‘‘Appropriate Use of Voluntary
Consensus Standards in Premarket
Submissions for Medical Devices,’’
issued September 14, 2018.12
For systems, a certificate (or
certification process) is an analogous
mechanism to document and declare
conformity. However, in our separate
proposal regarding harmonization of
Quality System requirements with an
international consensus standard, we
stated that FDA does not intend to
exempt from FDA inspections
manufacturers that are certified as
conforming to the standard (see 87 FR
10119 at 10128). Further, FDA does not
intend to develop a certification
program or issue such certificates (see
87 FR 10119 at 10128). As explained
elsewhere in this document, FDA does
not view OTC hearing aids as a unique
case for purposes of Quality System
requirements. As such, we are declining
to modify how manufacturers may use
Declarations of Conformity or to accept
certifications in lieu of demonstrating
compliance under FDA’s usual policies
for the manufacture of OTC hearing
aids. Should FDA determine to follow a
different general approach to
certifications for purposes of quality
management, we will announce such a
determination in the final rule based on
our proposal to harmonize part 820 with
ISO 13485:2016.
(Comment 97) Multiple comments
proposed that OTC hearing aids be
exempt from the Quality System
requirements of part 820. Some of these
comments stated that the requirements
of the Hearing Aid Restrictions,
§§ 801.420 and 801.421, addressed
safety concerns with specialized
labeling but that modern devices no
longer raise these concerns. As such,
these commenters viewed the
12 The document is available online at: https://
www.fda.gov/regulatory-information/search-fdaguidance-documents/appropriate-use-voluntaryconsensus-standards-premarket-submissionsmedical-devices.
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requirements under part 820 as
unnecessary.
(Response) FDA does not agree that
specialized labeling for, or the
diminution of past risks of, hearing aids
suggests that the OTC category of
hearing aids be exempt from Quality
System requirements. Rather, FDA
expects that the establishment and
continued application of an appropriate
Quality System would help reduce
device risks and support effectiveness,
and are an important control to help
provide for reasonable assurance of
safety and effectiveness. Further, an
appropriate Quality System serves
different purposes than labeling, and the
two are not substitutes for each other.
For example, a Quality System includes
production and process controls to
ensure that a device conforms to its
specifications (see § 820.70(a)). Labeling
does not serve this purpose and cannot
substitute for production and process
controls. We note that the
implementation of a Quality System
entails risk-based decision-making and
that the system’s appropriateness is
related to the device. The Quality
System requirements are inherently
flexible, and comments we received
agree that a Quality System that
complies with part 820 is not unduly
burdensome.
4. Choice and Specification of Standards
(Comment 98) Some comments
suggested that FDA not specify the exact
editions of the standards we are
incorporating by reference. In this way,
the commenters sought to simplify the
process for keeping regulations up to
date with new editions of the standards,
as the respective organizations develop
and publish them.
(Response) While FDA appreciates the
value in keeping regulations in sync
with consensus standards, we are not
adopting this suggestion as doing so
would impermissibly allow the
standards organizations to change
regulatory requirements without FDA
going through notice-and-comment
rulemaking. In addition, we note that,
under the incorporation by reference
regulations issued by the Office of the
Federal Register, incorporation by
reference of a publication is limited to
a specific edition and ‘‘future
amendments or revisions of the
publication are not included’’ (1 CFR
51.1(f)). Thus, under Federal
regulations, we cannot incorporate by
reference a specific standard and all
future editions of that standard. By
incorporating all or parts of a standard
by reference, we are referring to those
parts exactly as they are in that specific
edition, at the time we finalize the rule.
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(Comment 99) Some comments
observed that FDA proposed different
consensus standards for regulatory
purposes for OTC and prescription
hearing aids, specifically ANSI/CTA–
2051:2017 and ANSI/ASA S3.22–2014,
respectively. These comments raised
concerns that the different standards
treat the same hearing aid performance
aspects differently, which could be
confusing or create inconsistencies.
They proposed that FDA use only one
standard for both OTC and prescription
hearing aids.
(Response) FDA does not agree that
these standards treat the same
performance aspects differently. These
standards are not incompatible or
divergent for purposes of regulating
OTC and prescription hearing aids.
Rather, the standards serve different
purposes, which is appropriate for
regulating different categories of hearing
aids.
As we explained in the proposal,
ANSI/ASA S3.22–2014 specifies test
methods and measurement tolerances,
not device performance (see 86 FR
58150 at 58163). For example, ANSI/
ASA S3.22–2014 does not specify an
output limit. Instead, it describes to
manufacturers one way to determine the
maximum output, using an OSPL90
curve over a specific bandwidth, and
the measurement tolerance for it, that
the maximum ‘‘shall not exceed that
specified by the manufacturer plus 3
dB,’’ (see clause 6.2). ANSI/ASA S3.22–
2014 does not help provide for safety
and effectiveness by establishing a
baseline for performance but rather, in
effect, by defining common terms to
describe device performance.
ANSI/CTA–2051:2017 itself integrates
use of those common terms. For
example, ANSI/CTA–2051:2017 relies
on ANSI/ASA S3.22–2014 to describe
test methods by using OSPL90 curves.
(However, we note that in one place, the
standard refers to ANSI/ASA S3.22–
2009, rather than 2014, as a normative
reference.) In other words, one standard
builds on the other: ANSI/CTA–
2051:2017 specifies how well an
amplifier should perform instead of
leaving it solely to the manufacturer (as
ANSI/ASA S3.22–2014 does for hearing
aids), but in either case, the
specifications are measured and tested
based on ANSI/ASA S3.22–2014.
(Comment 100) Some comments
objected to the use of ANSI/CTA–
2051:2017 for purposes of regulating
hearing aids on the basis that an
industry group developed the standard
rather than a disinterested organization.
Other similar comments alternatively or
additionally objected that the standard
was developed for consumer electronics
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but not medical devices. In either case
or both, these comments argued, the use
of the standard is not appropriate for the
regulation of OTC hearing aids.
(Response) FDA acknowledges that, in
some cases, standards developed
specifically for medical devices may be
more appropriate for regulatory
purposes. For example, we are
continuing to apply Quality System
requirements specific to manufacturing
medical devices, as opposed to a quality
management system intended for other
kinds of manufacturers. We note that
the comments questioning the use of
ANSI/CTA–2051:2017, as opposed to a
standard specifically for medical
devices, generally did not question the
test methods or performance
specifications specifically—the major
exception being the device output limit
in clause 4.3, as discussed in the
previous section. (Some comments did
question the performance specifications
on grounds besides being adopted from
a consumer-technology standard. See,
for example, Comment 78 and the
response.)
Some of these comments suggested
that FDA use ANSI/ASA S3.22–2014
instead because that standard applies
specifically to hearing aids. However, as
explained in the response to Comment
99, the standards do not serve the same
purposes, so they are not substitutes for
each other. Additionally, as explained
in response to Comment 99, although
ANSI/CTA–2051:2017 specifies how
well an amplifier should perform
instead of leaving it solely to the
manufacturer (as ANSI/ASA S3.22–2014
does for hearing aids), in either case, the
specifications are measured and tested
based on ANSI/ASA S3.22–2014.
Although ANSI/CTA–2051:2017 was
intended for personal sound
amplification more generally than
hearing aids, as discussed elsewhere in
this document (see also the discussion
in 86 FR 58150 at 58163–64), the
performance specifications we are
adopting based on that standard will
provide reasonable assurance of safety
and effectiveness of OTC hearing aids.
We are therefore not replacing it with a
different standard.
(Comment 101) A comment stated
that FDA violated the Information
Quality Act by not subjecting the ‘‘CTA
Standard’’ to pre-dissemination review
requirements. This comment argued that
FDA cannot therefore use the ‘‘CTA
Standard’’ in support of the output
limits.
(Response) Neither the Information
Quality Act (IQA) nor any information
quality guidelines require FDA to
engage in the pre-dissemination review
this comment said is required.
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The IQA, or Data Quality Act,13
required the Director of the Office of
Management and Budget (OMB) to issue
‘‘guidelines . . . that provide policy and
procedural guidance to Federal agencies
for ensuring and maximizing the
quality, objectivity, utility, and integrity
of information (including statistical
information) disseminated by Federal
agencies.’’ Under the IQA, the
guidelines OMB issues must require
each covered Federal agency to issue
guidelines concerning information
‘‘disseminated by the agency,’’ and to
‘‘establish administrative mechanisms
allowing affected persons to seek and
obtain correction of information
maintained and disseminated by the
agency that does not comply’’ with
OMB’s guidelines. OMB’s initial
guidelines, as corrected, were published
in February 2002. ‘‘Guidelines for
Ensuring and Maximizing the Quality,
Objectivity, Utility, and Integrity of
Information Disseminated by Federal
Agencies; Republication’’ (67 FR 8452,
February 22, 2002) (‘‘OMB Guidelines’’).
HHS’s guidelines, which include the
FDA guidelines, were published in
September 2002 and have been
periodically updated (‘‘HHS/FDA
Guidelines’’).14
In 2005, OMB published its Final
Information Quality Bulletin for Peer
Review, which addressed ‘‘peer review
of scientific information disseminations
that contain findings or conclusions that
represent the official position of one or
more agencies of the Federal
government’’ (70 FR 2664 at 2666,
January 14, 2005). In 2019, OMB issued
a Memorandum entitled ‘‘Improving
Implementation of the Information
Quality Act’’ (‘‘Improving
Implementation Memorandum’’),15 the
purpose of which was to ‘‘reinforce,
clarify, and interpret agency
responsibilities with regard to
responsibilities under the Information
Quality Act (IQA).’’
As an initial matter, the IQA ‘‘orders
the Office of Management and Budget to
draft guidelines concerning information
quality and specifies what those
guidelines should contain.’’ Salt Inst. v.
Leavitt, 440 F.3d 156, 159 (4th Cir.
2006). The IQA does not require predissemination review. Nevertheless, to
the extent pre-dissemination review
may be required under the OMB
Guidelines, it would not apply here, as
13 Section 515 of the Treasury and General
Government Appropriations Act, 2001, Public Law
106–554 (2000) (codified at 44 U.S.C. 3516 note).
14 These are available at https://aspe.hhs.gov/
reports/hhs-guidelines-ensuring-maximizingquality-objectivity-utility-integrity-informationdisseminated.
15 M–19–15 (April 24, 2019).
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FDA did not disseminate the referenced
information.
The specific source this comment
asserted required pre-dissemination
review is ANSI/CTA–2051, a voluntary
consensus standard established by the
ANSI and the CTA. In the proposal,
FDA explained that the Agency is
basing its proposed output limits on
physiological data and stakeholder
input. ANSI/CTA–2051:2017 is one of
the scientific sources FDA has
considered. Other data and scientific
sources considered are described in the
proposal and include a national
workplace safety guideline from the
National Institute for Occupational
Safety and Health, comments from
speakers at a 2017 public workshop
meeting held by NASEM, and public
comments stemming from a 2016 FDA
public workshop (Refs. 14 and 15).
The IQA and associated information
quality guidelines concern only
information ‘‘disseminated’’ by a
Federal agency. ANSI/CTA–2051:2017
is not within the scope of the IQA and
OMB guidelines because it is
disseminated by ANSI and CTA, not a
Federal agency. See, e.g., HHS
Guidelines section I.D.2.h.
(‘‘ ‘Dissemination’ means agency
initiated or sponsored distribution of
information to the public.’’). Because a
Federal agency did not develop or
disseminate ANSI/CTA–2051:2017,
ANSI/CTA–2051:2017 is not within the
scope of the IQA or any information
quality guidelines, and is not subject to
any pre-dissemination review
requirements arising under them.
FDA is committed to using and
developing high quality information and
follows the applicable requirements and
guidelines. See, e.g., 67 FR 8452 at 8459
(‘‘Agencies shall treat information
quality as integral to every step of an
agency’s development of information,
including creation, collection,
maintenance, and dissemination.’’).
Additionally, as discussed elsewhere in
this document and as discussed in the
proposal (see 86 FR 58150 at 58163–64),
FDA believes the performance
specifications for OTC hearing aids,
having taken into account ANSI/CTA–
2051:2017, will provide reasonable
assurance of safety and effectiveness of
these devices.
(Comment 102) A comment stated
that FDA has denied the right of a work
group, composed of several third-party
trade groups and/or professional
associations, to seek or secure adoption
of a purported voluntary consensus
standard it has put forth (‘‘work group’s
standard’’). This comment stated that
the National Technology Transfer and
Advancement Act, OMB Circular No.
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A–119, the Administrative Procedure
Act, the Information Quality Act, and
Executive Order 12866 give this work
group that right. The comment further
stated that, to remedy the alleged
violation(s), FDA must incorporate the
work group’s standard into an amended
notice of proposed rulemaking or the
final rule.
(Response) None of the authorities
this comment cited require FDA to
adopt the work group’s standard.
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (NTTAA) states that ‘‘all
Federal agencies and departments shall
use technical standards that are
developed or adopted by voluntary
consensus standards bodies’’ unless
their use is ‘‘inconsistent with
applicable law or otherwise
impractical.’’ Public Law 104–113,
section 12(d)(1), (3) (1996). Office of
Management and Budget Circular No.
A–119, as revised (Circular A–119),
implements NTTAA section 12(d) by
establishing policies on Federal use of
voluntary consensus standards, among
other things. Contrary to this comment’s
assertion, the work group’s standard
does not fit within Circular A–119’s
definition of a ‘‘voluntary consensus
standard.’’ According to this comment,
the work group’s standard was created
by several trade groups and/or
professional associations. So the work
group’s standard is not a voluntary
consensus standard within the meaning
of Circular A–119, because it was not
‘‘developed or adopted’’ by an
organization that ‘‘plan[s], develop[s],
establish[es], or coordinate[s] voluntary
consensus standards using agreed-upon
procedures.’’ Circular A–119 section
4.A., 4.A.1. But even if the work group’s
standard were a voluntary consensus
standard, nothing in NTTAA or Circular
A–119 would require FDA to choose it
over ANSI/CTA–2051:2017, the
voluntary consensus standard FDA
included in the proposal. As explained
in the proposal, ANSI/CTA–2051:2017
is, to FDA’s knowledge, the first
voluntary consensus standard to
describe performance characteristics for
hearing amplifiers. In the proposal, FDA
proposed to establish as requirements a
subset of specifications from ANSI/
CTA–2051:2017, in conjunction with
other proposals. FDA’s actions are
consistent with NTTAA and Circular A–
119. Indeed, Circular A–119 states that
it ‘‘does not establish a preference
among standards developed in the
private sector.’’ Id. section 6.g.
This comment did not identify any
language in the Administrative
Procedure Act (APA) or IQA it claimed
would require FDA to adopt the work
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group’s standard. And these statutes do
not require FDA to adopt any particular
standard. These are procedural statutes
that do not demand specific substantive
outcomes, let alone use by FDA of any
commenter’s preferred standard.
Finally, this comment asserted that
the ‘‘compelling need requirement’’ set
forth in Executive Order 12866 prohibits
FDA’s consideration of ANSI/CTA–
2051. Under Executive Order 12866,
Federal agencies should issue only such
regulations as are required by law, are
necessary to interpret the law, or are
made necessary by compelling public
need, such as material failures of private
markets to protect or improve the health
and safety of the public, the
environment, or the well-being of the
American people. Regulatory Planning
and Review, section 1, 58 FR 51735
(September 30, 1993). FDA has
complied with this provision of
Executive Order 12866 because the
regulation it is issuing is ‘‘required by
law.’’ See FDARA, section 709(b) (2017).
In any event, Executive Order 12866
‘‘reaffirm[s] the primacy of Federal
agencies in the regulatory decisionmaking process,’’ gives ‘‘due regard to
the discretion that has been entrusted to
the Federal agencies,’’ recognizes that
‘‘Federal agencies are the repositories of
significant substantive expertise and
experience,’’ and does not ‘‘displac[e]
the agencies’ authority or
responsibilities, as authorized by law.’’
Executive Order 12866 pmbl., sections
2(a), 9; see In re United Mine Workers
of Am. Int’l Union, 190 F.3d 545, 551
(D.C. Cir. 1999) (stating that Executive
Order 12866 ‘‘does not purport’’ to ‘‘set
aside congressional legislation’’).
Executive Order 12866 certainly does
not prohibit or require adoption of any
particular standard. See Helicopter
Ass’n Int’l, Inc. v. FAA, 722 F.3d 430,
439 (D.C. Cir. 2013) (explaining that
Executive Order 12866 does not
‘‘create[] private rights’’).
(Comment 103) A comment stated
that a third party provided a standard to
FDA in advance of the proposal, and
that FDA’s alleged failure to consider
that standard before issuing the
proposal is arbitrary and capricious and
therefore a violation of the
Administrative Procedure Act.
(Response) The APA’s notice-andcomment procedures provide the
requirements that govern this
rulemaking, and do not require the kind
of pre-proposal special consideration
this comment discussed.
Consistent with the APA, FDA
published in the Federal Register, a
‘‘[g]eneral notice of proposed
rulemaking’’ that included, among other
things, ‘‘the terms or substance of the
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proposed rule or a description of the
subjects and issues involved.’’ 5 U.S.C.
553(b)(3). The APA states that, ‘‘[a]fter
notice required’’ thereby, the agency
‘‘shall give interested persons an
opportunity to participate in the rule
making through submission of written
data, views, or arguments.’’ Id. section
553(c). FDA has complied with this
provision by, in the proposal, soliciting
public comment.
FDA has considered the comments
received in response to the proposal,
and is in this preamble responding as
appropriate. But the APA’s notice-andcomment procedures, which require
that the public be given an opportunity
to participate in the rule making only
‘‘[a]fter’’ publication of the notice of
proposed rulemaking (NPRM), id., do
not require that FDA consider or
respond to any comments received in
advance of the NPRM.
G. Conditions for OTC Sale (§ 800.30(g))
Many comments on the conditions for
sale of OTC hearing aids sought more
stringent conditions or enforcement to
prevent possible misuses of OTC
hearing aids. Although FDA is attentive
to these concerns, we are also mindful
of unduly impeding access by creating
barriers rather than removing them if
appropriate (see also 86 FR 58150 at
58166).
(Comment 104) Some comments
suggested that FDA require any seller of
OTC hearing aids to staff customer
support in the United States with
licensed persons, for customers to meet
with them via telemedicine technology.
(Response) FDA is not adopting these
suggestions because this would require
the involvement of a licensed person in
the sale of an OTC hearing aid, contrary
to section 520(q)(1)(A)(v) of the FD&C
Act and section 709(b)(2)(D) of FDARA.
Further, the requirements in this
rulemaking will provide reasonable
assurance of safety and effectiveness of
OTC hearing aids without the
involvement of a licensed person. In any
case, FDA would expect such a
requirement to entail substantial,
perhaps prohibitive, costs for sellers in
addition to a significant amount of time
to develop or contract for such services.
Neither would be compatible with the
purposes of this rulemaking, including
the purpose of broadening the kinds of
sellers that can offer OTC hearing aids.
(Comment 105) Multiple comments
proposed a requirement for age
verification prior to the sale or delivery
of an OTC hearing aid. Similarly,
comments proposed a requirement for
purchasers to affirm that they are at
least 18 years old at the time of
purchase. Some of these additionally
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proposed that purchasers acknowledge
or agree that the OTC hearing aid is not
for use by anyone younger than 18 years
old.
(Response) FDA is not adopting these
suggestions. While people younger than
18 should not use hearing aids without
the involvement of a licensed person,
such as an ear-nose-throat doctor, we do
not agree that the risk warrants age
verification at this time.
We considered other purchases that
require age verification and found that,
in such cases, the risks to individuals
and the public health were significantly
greater than the risks posed by the use
of OTC hearing aids by people younger
than 18. Furthermore, we do not expect
that OTC hearing aids will be as
attractive for purchase by people
younger than 18 as other age-restricted
products that do require verification.
Thus, the benefit of mandatory age
verification would likely be small
relative to the risks posed to the
individual by OTC hearing aids
compared to the benefit of restricting
and risks posed by other age-restricted
products.
At the same time, we would expect
mandatory age verification, or similar
processes like certifications or
acknowledgments, to increase the
difficulty or complexity of purchases by
people who are the intended users, and
can benefit from the use, of OTC hearing
aids. Since one of the purposes of this
rulemaking is to promote the public
health by reducing or eliminating
barriers to access for such people, we
considered which approach is likely to
benefit the public health more. In this
case, lower-income people or people
who live in relatively isolated
conditions (for example, in rural areas)
are more likely to benefit from
broadened access while at the same time
being less able to present official
documentation of their age (for example,
because they lack a driver’s license or
are buying hearing aids by mail). We
have determined that the public health
is better served at this time by not
imposing requirements for age
verification, certification, or
acknowledgment.
The above considerations also took
into account that we are finalizing
requirements to improve the warnings
against use of OTC hearing aids by
people younger than 18. We are also
finalizing the condition for sale that will
prohibit sale of OTC hearing aids to or
for people younger than 18 under new
§ 800.30(g)(1). These requirements,
along with the others in this rule, will
help provide reasonable assurance of
safety and effectiveness of OTC hearing
aids for the intended users without the
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50733
need for age verification. We expect that
sellers will likely adopt their own
practices, tailored to their business
models, to prevent violating this
condition for sale and/or engaging in a
prohibited act. Such practices may, but
are not required to, entail age
verification by checking a governmentissued photographic identification.
However, in some cases, the seller may
not need to check a government-issued
photographic identification, for
example, when the seller has personal
knowledge of the purchaser’s age or may
otherwise be certain that the purchaser
is 18 or older.
(Comment 106) Several comments
proposed that FDA enhance
enforcement of legal requirements for
labeling, sales, or other provisions for
legally marketing hearing aids. Similar
comments suggested that FDA enhance
enforcement for selling non-compliant
products as hearing aids, for example,
by making false or misleading
statements or improperly avoiding
premarket requirements for devices.
Other such comments urge in any case
that FDA monitor the sales of OTC
hearing aids and/or non-compliant
consumer electronics marketed as
hearing aids.
(Response) FDA intends to apply
existing practices for monitoring the
market and will take action, including
enforcement as necessary and
appropriate. Should stakeholders wish
to call FDA’s attention to potential
concerns that we may not otherwise
learn, including potential regulatory
misconduct, they may file a report
sometimes known as a trade complaint.
Anyone may file such a report (a
complaint), and we encourage people to
include supporting and contact
information for possible followup
questions. However, the reports can be
anonymous. More information about the
process is available on FDA’s website:
https://www.fda.gov/medical-devices/
medical-device-safety/reportingallegations-regulatory-misconduct. See
also the response to Comment 122
regarding the role of State authorities in
enforcing requirements applicable to
OTC hearing aids.
Moreover, we are finalizing labeling
requirements that describe the process
of reporting adverse events to FDA (see
final §§ 800.30(c)(2)(iii)(F) and
801.422(c)(2)(ii)(E)). Section 709(d) of
FDARA directs FDA to report on an
analysis of adverse events relating to
OTC hearing aids not later than 2 years
after the date we issue this final rule.
FDA expects this information to be
helpful in identifying and analyzing
device risk trends, and it will likely
inform enforcement prioritization.
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(Comment 107) Comments suggested
that FDA impose a penalty on persons
who sell an OTC hearing aid that is used
by a child.
(Response) The FD&C Act sets forth
penalties for prohibited acts respecting
devices and electronic products as
described in section IV of this document
(see 21 U.S.C. 331, 333, 360oo and
360pp(b)). Prohibited acts include,
among other things, doing or causing a
variety of acts involving adulterated
and/or misbranded devices (see, e.g., 21
U.S.C. 331(a)–(c), 331(k)). In turn, a
device is deemed adulterated and/or
misbranded for a variety of reasons (see
21 U.S.C. 351 and 352). For example, an
OTC hearing aid sold to or for a person
younger than 18 would not, among
other deficiencies, bear adequate
directions for use for such users. The
hearing aid would be deemed
misbranded (see 21 U.S.C. 352(f)), and
certain activities with respect to the
misbranded device (for example, the
introduction of the misbranded device
into interstate commerce) would be a
prohibited act in that example and
subject to the penalties under the FD&C
Act.
(Comment 108) Several comments
suggested that FDA establish a variety of
post-sale requirements on
manufacturers or sellers of OTC hearing
aids. Such proposals included
requirements that manufacturers or
sellers: accept returns for a certain
minimum period (either for money back
or credit), warrant certain features or
components for a given period, guaranty
products or services in some way, and/
or provide a minimum rescission period
(a period in which a buyer could cancel
the purchase).
Many of these comments mentioned
user satisfaction and that, if users buy
an unsatisfactory device and are unable
to return or exchange it, such users
could incur unnecessary expenses to
obtain a satisfactory OTC hearing aid or
forego hearing aid use entirely. Other
such comments described a benefit or
need to establish a national standard, as
opposed to one that varies by State, to
encourage broader availability of the
devices. The proposed time periods for
the application of such requirements
varied but were generally 30, 45, 60, or
90 days after purchase.
(Response) FDA is not establishing
the suggested post-sale requirements on
manufacturers or sellers of OTC hearing
aids. We are finalizing a requirement for
OTC hearing aid labeling to provide
notice of the manufacturer’s return
policy. We believe this adequately
addresses the concern mentioned in the
comments that the risk of obtaining an
unsatisfactory OTC hearing aid may
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result in people foregoing hearing aid
use entirely, and that additional
requirements in this regard are not
necessary to provide a reasonable
assurance of safety and effectiveness for
OTC hearing aids. To the extent the
post-sale requirements proposed in the
comments are aimed at consumer
protection rather than providing a
reasonable assurance of safety and
effectiveness for OTC hearing aids, we
note that there may be other Federal
laws, administered by other agencies
that provide this type of consumer
protection. Likewise, many States have
existing requirements that also address
these types of consumer protection
concerns. See the response to Comment
122 regarding the applicability of State
consumer protection requirements.
(Comment 109) A comment proposed
that FDA prohibit the resale of OTC
hearing aids by consumers. The
comment expressed a need for
appropriate disinfection of used hearing
aids and the need to apply labeling
required for used hearing aids. The
comment asserted that used OTC
hearing aids should be returned by the
vendor to the manufacturer for it to take
the necessary steps to market a used
OTC hearing aid.
(Response) Although FDA agrees that
all used hearing aids should be labeled
as required and adequately reprocessed
regardless of the type of reseller, we are
declining to revise the proposed rule to
incorporate this suggestion. We are
finalizing the requirement that if the
OTC hearing aid is used or rebuilt, the
outside package must declare that fact,
and we have modified the design
requirements for OTC hearing aids to
specify that if the OTC hearing aid is
used or rebuilt, it must be adequately
reprocessed for the next user prior to
sale. OTC hearing aids must meet these
requirements regardless of the type of
reseller. We believe that the
requirements that we are finalizing for
OTC hearing aids provide for reasonable
assurance of safety and effectiveness,
and prohibiting resale of an OTC
hearing aid by a consumer will not add
anything and will likely be impractical
to enforce.
(Comment 110) Comments proposed
that FDA require referrals to physicians
for prescription hearing aids when a
user or prospective user manifests any
of the ‘‘red flag’’ conditions. However,
one such comment proposed an option
for waivers since, it asserted, most
people with a ‘‘red flag’’ condition have
already been advised to seek or
previously sought an examination by a
physician.
(Response) FDA is declining this
suggestion because it would require the
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involvement of a licensed person in the
use of OTC hearing aids in some cases,
and it is not necessary for reasonable
assurance of safety and effectiveness of
OTC hearing aids. We believe that the
required prominent warnings and other
statements in the labeling of OTC
hearing aids are sufficient to advise
users and prospective users to consult
hearing health care providers, including
ENT doctors, in certain circumstances,
such as when experiencing certain
pathological (‘‘red flag’’) conditions. For
these reasons, we are not including an
examination or waiver requirement for
the OTC category of hearing aids.
(Comment 111) Some comments
urged FDA to establish generally morestringent requirements for the sale of
OTC hearing aids. These comments
reasoned that because hearing aids are
medical devices, are technologically
complex, and/or intended to
compensate for a complex condition,
they should not be as easily available as
other devices such as bandages (see,
e.g., 21 CFR 880.5075, classifying elastic
bandages).
(Response) Except as explained
elsewhere in this document, FDA is
declining this suggestion. We are
establishing requirements that are
sufficiently stringent to provide
reasonable assurance of safety and
effectiveness of OTC hearing aids. We
have taken into account, among other
considerations, the seriousness of
hearing impairment as well as the
complexity of both the impairment and
the technology intended to compensate
for it. More stringent requirements are
not necessary to provide reasonable
assurance of safety and effectiveness,
and the requirements we are
establishing generally do not depend on
the sales environment, provided the
environment does not cause the device
to be adulterated, misbranded, or
otherwise out of compliance with
applicable requirements (see, e.g., 21
U.S.C. 351(a)(2)(A) regarding
adulteration if held under insanitary
conditions).
Moreover, the extent to which the
availability of OTC hearing aids is
comparable to that of elastic bandages
does not suggest the devices themselves
are otherwise similar. Similarly, the
broad availability of elastic bandages
does not cause the devices to be less
safe and effective for their intended
use(s), and the same would be true for
OTC hearing aids. The purposes of this
rule include promoting broader
availability of OTC hearing aids while
establishing requirements that will
provide reasonable assurance of safety
and effectiveness, which is
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incompatible with establishing
unnecessarily stringent regulations.
(Comment 112) Comments suggested
that sellers of OTC hearing aids be
required to keep the devices behind the
counter or in a locked cabinet to prevent
people younger than 18 from purchasing
the devices.
(Response) FDA is declining this
suggestion because we are allowing
flexibility for sellers to determine how
to comply with the condition for sale
that prohibits the sale of OTC hearing
aids to or for people younger than 18.
FDA intends this flexibility to minimize
regulatory burdens while promoting
access to safe and effective devices. If a
seller determines that it can comply
with the condition for sale without
special storage provisions, then it need
not make such storage provisions.
Mandating special storage provisions for
such sellers of OTC hearing aids would
add unnecessary burdens. However, a
seller may decide keeping the devices in
a locked display case and verifying the
purchaser’s age with a form of
photographic identification will be the
most practical approach for its
circumstances. (See also the response to
Comment 105 regarding age
verification.) Although we are not
mandating a specific approach to ensure
that OTC hearing aids are not sold to
people younger than 18, FDA expects
that sellers will implement an approach
appropriate for their circumstances.
(Comment 113) A comment suggested
pairing the purchase of an OTC hearing
aid with membership in an organization
that could serve first-time hearing aid
users, for example, by assisting with or
explaining the initial selection and
purchase of an OTC hearing aid.
(Response) FDA is not adopting this
suggestion as condition for sale of OTC
hearing aids. Although such
organizations can provide useful and
valuable services for users and
prospective users of hearing aids, FDA
proposed and is finalizing requirements
for OTC hearing aids that would provide
reasonable assurance of safety and
effectiveness without the involvement
of a licensed person. Requiring the
involvement of such an organization is
neither necessary for reasonable
assurance of safety and effectiveness nor
consistent with the approach we are
taking to establish the OTC category for
hearing aids to promote broader
availability of OTC hearing aids.
Further, as we explained in the
proposal, we expect this final rule to
lower costs of hearing aids by
unbundling the purchase of hearing aids
from professional services, including
professional advice, fitting, adjustment,
or maintenance to make the devices
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available over the counter (see 86 FR
58150 at 58172). Requiring membership
in an organization with the purchase of
OTC hearing aids would be contrary to
our intent of unbundling services and
device purchases. In that vein, we
would expect that membership with
such an organization would present
costs to users, either directly, as in a
membership fee, or indirectly, as in
increasing the purchase price of a
device. Thus, although users and
prospective users may choose to seek
membership with organizations to
obtain related benefits, we do not agree
that such membership should be
required with the purchase of an OTC
hearing aid.
(Comment 114) A comment proposed
that FDA require sellers of OTC hearing
aids to obtain certifications for relevant
standards developed by the ISO as well
as comply with appropriate Quality
System requirements. For example,
dispensers might conform to ISO
21388:2020, ‘‘Acoustics—Hearing aid
fitting management.’’
(Response) FDA is not requiring
sellers of OTC hearing aids that are not
manufacturers to comply with part 820
requirements for a Quality System or
conform to consensus standards. An
OTC hearing aid, by definition, is a
device that, among other qualities,
allows the user to control and customize
it to the user’s hearing needs, without
the involvement of a licensed person
(see 21 U.S.C. 360j(q)(1)(A)(iii) and (v)).
Further, multiple provisions of this rule
are intended to ensure that persons do
not incur special licensing obligations
or the equivalent (certifications, for
example) on account of commercial
activity involving OTC hearing aids
(see, e.g., final § 800.30(h)(2)(i)). As
such, requiring a seller of OTC hearing
aids to be specially licensed or certified
is both unnecessary for reasonable
assurance of safety and effectiveness of
OTC hearing aids and inconsistent with
the approach we are taking to establish
the OTC category for hearing aids.
Additionally, the scope of part 820
extends to manufacturers of finished
devices, as § 820.3(o) defines the term,
but generally not other persons (see
§ 820.1(a)(1)), and the requirements of
part 820 are not intended to extend to
sellers who are not manufacturers.
Instead, part 820 specifies that, among
other controls, manufacturers must
ensure that device labeling, packaging
and shipping containers maintain label
and device integrity during customary
conditions of processing, storage,
handling, and distribution (see
§§ 820.120(a) and 820.130).
We likewise observe that the
consensus standard ISO 21388:2020
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applies to hearing aid fitting
management (see clause 1), but not nonlicensed persons (i.e., non-hearing aid
professionals). As such, this standard is
not likely to apply to sellers of OTC
hearing aids who are not licensed
persons. As we explained above, sellers
of OTC hearing aids are not required to
have a specialized license or the
equivalent.
Nevertheless, FDA acknowledges that
quality management may also be useful
to many persons who are not
manufacturers or hearing aid
professionals (as ISO 21388:2020
defines the term). Some concepts in part
820, ISO 21388:2020, or ISO
13485:2016, for example, may help
inform such other person’s
determination of best practices. A
number of standards exist for other
persons to implement quality
management systems, for example, ISO
9001:2015, ‘‘Quality management
systems—Requirements,’’ and those
persons may wish to obtain related
certifications and advertise as such.
However, FDA has determined that
special licensing (or its equivalent) is
not necessary, as explained, and we are
not requiring sellers of OTC hearing aids
that are not manufacturers to comply
with part 820 or conform to ISO
21388:2020, ISO 13485:2016, or any
other consensus standard.
(Comment 115) A comment proposed
that FDA protect consumers from
predatory practices throughout the
supply chain for OTC hearing aids. It
specifically referred to unnecessarily
collecting or sharing private information
by or with several kinds of persons:
manufactures, retailers, medical
practitioners, payment processors,
service providers, device monitoring
and configuration providers, data
aggregators, computer hosting services,
and platforms.
(Response) FDA is declining this
proposal because it is not necessary for
reasonable assurance of safety and
effectiveness of OTC hearing aids.
Moreover, although certain deceptive
practices would be prohibited under the
FD&C Act, other Federal and State
agencies establish and enforce such
requirements as those concerning
protection of private information. For
example, if a seller were to modify the
labeling of an OTC hearing aid to
mislead prospective purchasers, that
would constitute misbranding of a
device while held for sale in interstate
commerce, which is prohibited under
the FD&C Act (see, e.g., 21 U.S.C.
331(k)). Deceiving prospective
purchasers in such a way may
additionally violate Federal and/or State
requirements that FDA is not
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responsible for administering or
enforcing. For more information about
the kinds of health fraud issues FDA
addresses, which includes unlawful
sales of medical products, you may visit
our website: https://www.fda.gov/
consumers/health-fraud-scams.
However, FDA does not generally
administer or enforce requirements
respecting predatory commercial
practices that do not involve the safety
or effectiveness of FDA-regulated
products. Should stakeholders wish to
raise concerns for deceptive practices
not related to requirements that FDA
administers or enforces, they should
approach the appropriate Federal or
State agencies. For example,
stakeholders may wish to report fraud to
the Federal Trade Commission’s Bureau
of Consumer Protection. More
information is available online: https://
www.ftc.gov/about-ftc/bureaus-offices/
bureau-consumer-protection.
(Additional Revision 4) FDA is
finalizing a condition for sale for OTC
hearing aids that sellers may not sell the
devices over the counter unless the
principal display panel of the outside
package labeling bear prominent marks
identifying the device as ‘‘OTC’’ and a
‘‘hearing aid.’’ As explained in
Additional Revision 2 (section III.D.3),
FDA is finalizing a requirement for the
outside package labeling to bear the
marks to assist purchasers and others,
including retailers and State agencies.
However, in some cases, purchasers
may not view the principal display
panel of the package prior to purchase.
For example, a person shopping online
may filter a list of the devices offered by
the seller with ‘‘OTC’’ and view only
pictures of the device itself. This
condition for sale will help ensure that
only OTC hearing aids are sold as such,
particularly for purchasers who shop
online or by mail. This is necessary for
reasonable assurance of safety and
effectiveness of OTC hearing aids
because it provides assurances that nonOTC hearing aids or non-hearing aids
will not be sold as or confused for OTC
hearing aids.
H. Preemption Provisions (§ 800.30(h))
Most comments on preemption sought
clarification on the effects of this rule on
State and local requirements, including
consumer protections and professional
licensing requirements. Many strongly
supported preserving States’ roles in
protecting prospective and current
hearing aid users.
(Comment 116) Several comments
suggested that FDA define ‘‘restrict or
interfere’’ in the FDARA preemption
provision because these terms are
ambiguous. Specifically, one suggestion
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was that FDA define ‘‘restrict or
interfere’’ to pertain only to State and
local laws that prevent or create an
obstacle to a commercial activity
involving OTC hearing aids so that State
consumer protection laws that pertain to
commercial activity involving OTC
hearing aids, such as a warranty
requirement and mandatory returns for
OTC hearing aids, would not be
preempted. Another suggestion was that
FDA define ‘‘restrict or interfere’’ to
mean ‘‘present actual legal or
procedural impediment to the exclusion
of business disincentives.’’ One
comment expressed concerns that return
requirements could be viewed as
interfering with distribution of OTC
hearing aids because such requirements
make distribution chains more
complicated and potentially more
expensive; warranty requirements
would, by mandating servicing of OTC
hearing aids, interfere with the servicing
of the devices; and both kinds of
requirements could be viewed as
discouraging the sale of OTC hearing
aids by increasing prices for patients.
(Response) FDA declines to include
the definitions suggested by comments
because the Agency is concerned that
the suggested definitions may not be
consistent with ‘‘restrict or interfere
with’’ in section 709(b)(4) of FDARA.
For example, the dictionary defines
‘‘restrict’’ to mean ‘‘to confine within
bounds,’’ Merriam-Webster at https://
www.merriam-webster.com/dictionary/
restrict, and this definition seems
somewhat different from ‘‘prevent or
create an obstacle’’ or ‘‘present actual
legal or procedural impediments.’’
Instead of adopting the definitions
proposed by the comments or some
other definition, in assessing whether a
State or local requirement would
‘‘restrict or interfere with’’ commercial
activity involving OTC hearing aids,
FDA intends to consider, among other
things, the ordinary meaning of these
terms in the context of section 709 of
FDARA, including the objectives of
section 709, and the specific facts, such
as the specific language of the State or
local requirement and the effects of the
requirement on commercial activity
involving OTC hearing aids.
One of the reasons for the proposed
definitions of ‘‘restrict or interfere’’ in
the comments appears to be the concern
that State consumer protection laws,
such as those that provide for a return
period or warranty for hearing aids,
would be preempted under section
709(b)(4) of FDARA. For a discussion of
this topic, see the response to Comment
122.
FDA notes that ‘‘restrict or interfere
with’’ is just one element of the FDARA
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preemption provision in section
709(b)(4). In other words, there are other
elements to consider in assessing
whether a State or local requirement is
preempted under section 709(b)(4) of
FDARA, such as whether the State or
local requirement is ‘‘specifically
related to hearing products.’’ As
discussed in the proposal, we do not
interpret FDARA to preempt generally
applicable requirements, i.e.,
requirements that relate to other
products in addition to hearing
products, to services not specific to
hearing products, or to unfair trade
practices in which the requirements are
not limited to hearing products. See 86
FR 58150 at 58167 for further
discussion.
(Comment 117) A comment suggested
that FDA consider requests from States
for exemption from Federal preemption
as OTC devices enter the market.
Another comment suggested that FDA
state in the final rule that the existing
processes in § 808.20 (21 CFR 808.20)
(which relate to requests for exemption
from Federal preemption under section
521 of the FD&C Act) will continue to
apply, and that FDA will find against
preemption when consistent with the
statutory language and ‘‘in the public
interest.’’
(Response) As discussed in the
proposal, section 709(b)(4) of FDARA
established preemption specific to OTC
hearing aids that is different from the
general rule for preemption under
section 521 of the FD&C Act. See 86 FR
58150 at 58166. Unlike section 521 of
the FD&C Act, section 709(b)(4) of
FDARA does not provide for any
exemptions for State or local
requirements that fall within this
provision. Therefore, FDA is unable to
provide exemptions from preemption
for State or local requirements that fall
within the scope of section 709(b)(4).
Section 521 of the FD&C Act does
provide for exemption from preemption
for State or local requirements that fall
within this provision, and the
procedures for requesting and granting
or denying an exemption are provided
in part 808, subpart B (21 CFR part 808,
subpart B). Section 808.20 will continue
to apply to State or local requirements
that fall within section 521 of the FD&C
Act, such as requirements for
prescription hearing aids. FDA did not
propose any changes to § 808.20.
FDA intends to assess preemption
consistent with the statutory language of
section 709(b)(4) of FDARA for State or
local requirements that fall within this
provision. We believe this approach to
assessing preemption is consistent with
the Supreme Court’s approach to
Federal preemption. See, e.g., Puerto
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Rico v. Franklin Cal. Tax-Free Trust,
579 U.S. 115, 125 (2016) (explaining
that ‘‘because the statute contains an
express preemption clause, we do not
invoke any presumption against
preemption but instead focus on the
plain wording of the clause, which
necessarily contains the best evidence of
Congress’ pre-emptive intent.’’ (citations
and internal quotations omitted)).
Additionally, FDA believes that this
approach will achieve the objectives of
section 709 of FDARA, which include
promoting access to safe and effective
OTC hearing aids for adults with
perceived mild to moderate hearing
impairment, and in so doing, will be in
the public interest. FDA also intends to
assess preemption consistent with
section 521 of the FD&C Act for State or
local requirements that fall within this
provision, and consider exemption from
preemption when requested in
accordance with § 808.20. As indicated
in § 808.20, FDA considers, among other
things, information on how the public
health may be benefitted if an
exemption is granted.
(Comment 118) A comment suggested
that FDA set up an informal process by
which States could request feedback
from the Agency about whether specific
requirements are preempted under
section 709(b)(4) of FDARA. Another
comment requested that FDA specify in
the final rule that the process in
§ 808.5(a) (21 CFR 808.5(a)) apply to
State and local requirements concerning
hearing products because this process
would increase transparency.
(Response) At this time, FDA does not
believe it is necessary to set up a
separate informal process for States or
localities to request feedback from the
Agency about whether specific
requirements are preempted under
section 709(b)(4) of FDARA because
there are existing informal processes
that States or localities can use to make
such requests. For example, State or
localities that have questions about
preemption may contact the Center for
Devices and Radiological Health
(CDRH)’s Ombudsman at
cdrhombudsman@fda.hhs.gov or FDA’s
Intergovernmental Affairs Staff at IGA@
fda.hhs.gov. (CDRH’s Division of
Industry and Consumer Education can
also answer general questions regarding
device regulation.) Additionally, we
note that § 808.5(a) does not set forth a
separate process but rather relies on the
advisory opinion process in § 10.85 (21
CFR 10.85). States or localities may
request an advisory opinion under
§ 10.85 with respect to whether FDA
regards a particular State or local
requirement as preempted under section
709(b)(4) of FDARA.
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(Comment 119) Two comments noted
that part 808 includes a list of the types
of State or local requirements that are
not preempted, and requested that FDA
expand this list with additional
examples pertaining to hearing aids,
such as requirements that relate to
warranties, returns, and the sale of
hearing aids for users under 18 years of
age.
(Response) The list in part 808 of the
types of State or local requirements that
are not preempted pertains to
preemption under section 521 of the
FD&C Act. Specifically, § 808.1(d)
provides examples of the types of State
or local requirements that are not
preempted by section 521 of the FD&C
Act, including examples of State or local
requirements that are not considered
‘‘requirements applicable to a device’’
under section 521 of the FD&C Act.
However, providing general categories
of State or local requirement on hearing
aids that are not preempted under
section 709(b)(4) of FDARA would be
challenging because preemption under
this section depends in part on whether
the requirement would ‘‘restrict or
interfere with’’ commercial activity
involving OTC hearing aids. Whether a
State or local requirement would
‘‘restrict or interfere with’’ commercial
activity involving OTC hearing aids will
depend on the specific facts, including
the specific language of the State or
local requirement and the effects of the
requirement.
We note that in the proposal, we did
provide specific examples of State or
local requirements that we believe
would or would not be preempted
under section 709(b)(4) of FDARA. See
86 FR 58150 at 58167–68. Additionally,
as discussed in the proposal, we do not
interpret section 709(b)(4) of FDARA to
preempt generally applicable
requirements, i.e., requirements that
relate to other products in addition to
hearing products, to services not
specific to hearing products, or to unfair
trade practices in which the
requirements are not limited to hearing
products. See 86 FR 58150 at 58167 for
further discussion. However, we noted
that if a State or local requirement
appears on its face to be generally
applicable, but in practice it was
specifically related to hearing products
and would restrict or interfere with
commercial activity involving OTC
hearing aids, the requirement would be
preempted. See 86 FR 58150 at 58167.
Further, State or local requirements
specifically related to hearing products
would not be preempted under section
709(b)(4) of FDARA if they would not
restrict or interfere with commercial
activity involving OTC hearing aids. For
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50737
example, we believe that reasonable
return or warranty requirements for
OTC hearing aids would likely promote,
rather than restrict or interfere with,
commercial activity involving OTC
hearing aids by reducing the financial
risk to purchasers. For further
discussion of this topic, see the
response to Comment 122.
We also note that section 709(b)(5) of
FDARA specifies, ‘‘[n]othing in this
section shall be construed to modify or
otherwise affect the ability of any
person to exercise a private right of
action under any State or Federal
product liability, tort, warranty,
contract, or consumer protection law.’’
Therefore, laws that fall within the
scope of this savings clause would not
be preempted under section 709(b)(4) of
FDARA provided that they do not
conflict with the OTC Hearing Aid
Controls or frustrate the purposes and
objectives of section 709 of FDARA. See,
e.g., Am. Tel. and Tel. Co. v. Central
Office Tel., Inc., 524 U.S. 214, 226
(1998) (holding that a remedies savings
clause in the Communications Act of
1934 did not save State laws that were
inconsistent with Federal law);
Automobile Importers of America, Inc.
v. Minnesota, 871 F.2d 717, 722 (8th
Cir. 1989) (although the relevant Federal
statute had a broad savings clause, the
court stated ‘‘State legislation is
preempted if compliance with the state
law frustrates the purposes and
objectives of federal law’’).
States or localities that have questions
about preemption may contact CDRH’s
Ombudsman at cdrhombudsman@
fda.hhs.gov or FDA’s Intergovernmental
Affairs Staff at IGA@fda.hhs.gov, or they
may request an advisory opinion under
§ 10.85 with respect to whether FDA
regards a particular State or local
requirement as preempted under section
709(b)(4) of FDARA.
The OTC Hearing Aid Controls in
§ 800.30 do not apply to hearing aids
intended for users under 18 years of age.
Hearing aids intended for users under
18 years of age would be considered
prescription hearing aids as defined in
§§ 800.30(b) and 801.422(b). State or
local requirements governing the sale of
hearing aids for users under 18 years of
age would fall within the scope of
section 521 of the FD&C Act, and
therefore, that section and part 808
would continue to apply. To the extent
that a State or local requirement is
preempted under section 521 of the
FD&C Act, the State or political
subdivision may apply for exemption
from preemption in accordance with
part 808, subpart B.
(Comment 120) A comment from an
association of State Attorneys General
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stated that ‘‘the proposed rule includes
broad language that could be interpreted
to repeal virtually all the state-requested
exemptions from preemption issued by
the FDA since 1980—even those related
exclusively to non-OTC hearing aids’’
and that this could create confusion and
unnecessary litigation.
(Response) While we are removing
most of the regulations codifying the
exemption decisions, we are doing so
because we are repealing or revising the
specific counterpart Federal regulations
that preempted State and local
requirements respecting devices. In
addition, preemption specific to OTC
hearing aids would generally nullify the
exemptions to the extent the State or
local requirements would apply to OTC
hearing aids except in certain specific
circumstances.
With respect to OTC hearing aids, as
discussed in the proposal, section
709(b)(4) of FDARA established
preemption specific to OTC hearing aids
that is different from the general rule for
preemption under section 521 of the
FD&C Act. See 86 FR 58150 at 58166.
The FDARA preemption provision
preempts State and local requirements
specifically related to hearing products
that would restrict or interfere with
commercial activity involving OTC
hearing aids, and that are different from,
in addition to, or otherwise not identical
to regulations issued under FDARA
section 709(b). Unlike section 521 of the
FD&C Act, section 709(b)(4) of FDARA
does not provide for any exemptions for
State or local requirements that fall
within this provision. Therefore, FDA is
unable to continue in effect any
previously granted exemptions from
preemption for State or local
requirements that fall within the scope
of section 709(b)(4) of FDARA.
With respect to prescription hearing
aids and other State and local
requirements for hearing aids not
otherwise preempted by FDARA section
709(b)(4), FDA is removing all of the
regulations in part 808 related to
hearing aids; that is, almost all
regulations codifying the previous
decisions in §§ 808.53 through 808.101,
except for the portions of § 808.55
(California) that do not relate solely to
hearing aids. As discussed in the
proposal, those exemptions are no
longer applicable because this final rule
repeals or revises the underlying
Federal requirements from which those
exemptions were granted. See 86 FR
58150 at 58170. In addition, FDA is
aware that several States have modified
their requirements that were the subject
of the exemption decisions since they
applied for exemptions, in which case
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the exemption decision may no longer
be applicable.
We note that removal of these
exemptions does not itself mean that
those State or local laws are now
preempted given that we are repealing
or revising the specific counterpart
regulations. For example, the repeal of
the conditions for sale in § 801.421
means that State or local requirements
that differed from, or were in addition
to, the repealed counterpart Federal
requirements will no longer be
preempted under section 521(a) of the
FD&C Act (see § 808.1(d)). However,
some of the new requirements we are
establishing in this rule would implicate
preemption under section 521(a) of the
FD&C Act. For example, the
prescription hearing aid labeling
requirements set forth in § 801.422 will
preempt certain State or local
requirements that are different from, or
in addition to, those Federal
requirements. These new requirements
are similar but not identical to those in
§ 801.420 and include substantive
changes. To the extent that any
previously granted petitions for
exemptions related to labeling
requirements, any such exemptions
would be rendered inapplicable due to
changes in the underlying Federal
requirements from which the
exemptions were granted.
States or localities that have questions
about preemption may contact CDRH’s
Ombudsman at cdrhombudsman@
fda.hhs.gov or FDA’s Intergovernmental
Affairs Staff at IGA@fda.hhs.gov, or they
may request an advisory opinion under
§ 10.85 with respect to whether FDA
regards a particular State or local
requirement as preempted.
(Comment 121) A comment from the
Rhode Island Department of Health
noted that Rhode Island General Laws
sections 5–49–2.1 and 2.2 contain
provisions that would require
consumers or purchasers to obtain a
certificate of need from a physician who
attests that the individual is in need of
a hearing aid, and therefore requested
that FDA retain § 808.89, which denied
Rhode Island’s request for exemption
from preemption. Doing so, the
comment said, would align with FDA’s
approach of authorizing non-physician
licensed hearing professionals to make
determinations of need and would also
benefit consumers by reducing
unnecessary costs and added time to the
process of obtaining a hearing aid.
(Response) FDA has decided not to
retain § 808.89, because the repeal of the
conditions for sale in § 801.421
substantively changes the underlying
Federal requirements against which the
previous denial of exemption from
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preemption was made. The repeal of
§ 801.421 means Rhode Island General
Laws sections 5–49–2.1 and 2.2 are no
longer preempted under section 521(a)
of the FD&C Act, because no counterpart
Federal requirement exists (see
§ 808.1(d)). Without that preemption,
the previous denial would have no
effect even were we to retain the
regulation.
However, section 709(b)(4) of FDARA
would separately preempt the Rhode
Island provisions to a certain extent,
regardless of our previous exemption
decisions and whether or not § 808.89
were retained. For example, to the
extent the Rhode Island laws require a
certificate of need from a physician for
the sale of OTC hearing aids, they are
now preempted by FDARA section
709(b)(4), because they are specifically
related to hearing products, would
restrict or interfere with commercial
activity involving OTC hearing aids, and
are different from, in addition to, or
otherwise not identical to, FDA’s
regulations issued under FDARA
section 709(b).
(Comment 122) Some comments
expressed concern that State consumer
protections would be preempted. For
example, one comment stated that many
States tie consumer protections, such as
return requirements, for purchasers of
hearing aids to licensing requirements,
and stated that these protections would
be preempted under the proposed rule.
To address the concern, comments
recommended that Federal consumer
protections, such as requiring that
hearing aid sales be accompanied by a
receipt, information relating to
warranty, and mandatory return or trial
period, be established, for example as
conditions for sale under § 800.30(g).
(Response) FDA declines to include
the requirements suggested by
comments because at this time, the
Agency believes requiring that OTC
hearing aid sales be accompanied by a
receipt, information relating to
warranty, and mandatory return or trial
period is not necessary to provide
reasonable assurance of the safety and
effectiveness of OTC hearing aids.
FDA notes that the preemption
provision in § 800.30(h)(1) is intended
to incorporate the preemption provision
in section 709(b)(4) of FDARA. In other
words, the preemption provision in
§ 800.30(h)(1) simply reflects the statute,
which expresses clear Congressional
intent to preempt certain State and local
requirements. As explained in the
proposal, FDA decided to codify the
FDARA preemption provision in the
regulations to assist stakeholders in
understanding the legal framework for
OTC hearing aids given that the FDARA
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preemption provision was not
incorporated into the FD&C Act (a
process known as U.S. Code
classification). 86 FR 58150 at 58166. In
this response, FDA focuses on the
express preemption provision in section
709(b)(4) of FDARA but notes that there
are other types of preemption that may
apply such as conflict preemption. See,
e.g., Nat’l Fedn. of the Blind v. United
Airlines, Inc., 813 F.3d 718, 724 (9th
Cir. 2016) (describing conflict
preemption in addition to express
preemption).
Whether a State or local requirement
is preempted under section 709(b)(4) of
FDARA would depend on the specific
facts, including the language of the
requirement and the effects of the
requirement on commercial activity
involving OTC hearing aids. However,
FDA believes that many State or local
consumer protection requirements
would not be preempted under section
709(b)(4) of FDARA because they are
not ‘‘specifically related to hearing
products’’ or would not ‘‘restrict or
interfere with’’ commercial activity
involving OTC hearing aids. As
discussed in the proposal, we do not
interpret FDARA to preempt generally
applicable requirements, i.e.,
requirements that relate to other
products in addition to hearing
products, to services not specific to
hearing products, or to unfair trade
practices in which the requirements are
not limited to hearing products. See 86
FR 58150 at 58167. For example,
generally, we would not consider a State
or local warranty requirement for
assistive devices to be ‘‘specifically
related to hearing products’’ under
section 709(b)(4) of FDARA because the
requirement relates to other products
(e.g., wheelchairs) in addition to hearing
products.
Whether a State or local consumer
protection requirement that specifically
related to hearing products would
‘‘restrict or interfere with’’ commercial
activity involving OTC hearing aids
would depend on the specific facts.
However, generally, FDA believes that
State or local requirements that provide
for a reasonable warranty or return
period for hearing aids (e.g., 60-day
period) would likely promote, rather
than restrict or interfere with,
commercial activity involving OTC
hearing aids. Such requirements may
help to encourage people who could
benefit from an OTC hearing aid to
purchase the device by reducing their
financial risk. As discussed in the
proposal, despite the high prevalence
and public health impact of hearing
loss, only about one-fifth of people who
could benefit from a hearing aid seek
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intervention, likely due to barriers such
as high cost. 86 FR 58150 at 58151. An
important objective of section 709 is to
lower some of the barriers and improve
access to these devices for people who
could benefit from them. See id.; see
also ‘‘FDA User Fee Agreements:
Improving Medical Product Regulation
and Innovation for Patients, Part I,’’
Hearing before the Comm. on Health,
Education, Labor, and Pensions, 115th
Cong. 115–255 (2017), at 74 (Remarks by
Sen. Elizabeth Warren regarding S. 670,
the Over-the-Counter Hearing Aid Act of
2017, which was largely incorporated
into section 709 of FDARA, indicating
that this legislation was intended to
improve access and affordability to safe
and effective OTC hearing aids for
millions of consumers who could
benefit from these devices); ‘‘Examining
Improvements to the Regulation of
Medical Technologies,’’ Hearing before
the Subcomm. on Health of the H.
Comm. on Energy and Commerce, 115th
Cong. 115–28 (2017), at 3 (Statement of
Rep. Michael C. Burgess regarding H.R.
1652, the Over-the-Counter Hearing Aid
Act of 2017, which was largely
incorporated into section 709 of
FDARA, stating that this bill was
introduced ‘‘to safely increase access
and affordability in the hearing aid
market for millions of Americans from
whom it would benefit.’’).
Additionally, State or local
requirements that provide for reasonable
disclosure of the terms of sale in a
receipt or similar document would
likely promote, rather than restrict or
interfere with, commercial activity
involving OTC hearing aids by
providing important information in
writing, such as return or warranty
information, to help people with mild to
moderate hearing impairment make
fully informed purchasing decisions.
Congress also recognized the
importance of maintaining certain State
consumer protection laws as reflected in
section 709(b)(5) of FDARA.
Specifically, section 709(b)(5) states,
‘‘Nothing in this section shall be
construed to modify or otherwise affect
the ability of any person to exercise a
private right of action under any State
or Federal product liability, tort,
warranty, contract, or consumer
protection law.’’ Therefore, laws that
fall within this savings clause would not
be preempted unless they conflict with
the OTC Hearing Aid Controls or
frustrate the purposes and objectives of
section 709 of FDARA. See, e.g., Am.
Tel. and Tel. Co. v. Central Office Tel.,
Inc., 524 U.S. 214, 226 (1998) (holding
that a remedies savings clause in the
Communications Act of 1934 did not
save state laws that were inconsistent
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50739
with federal law); Automobile Importers
of America, Inc. v. Minnesota, 871 F.2d
717, 722 (8th Cir. 1989) (although the
relevant Federal statute had a broad
savings clause, the court stated ‘‘State
legislation is preempted if compliance
with the state law frustrates the
purposes and objectives of federal
law’’).
With regard to State or local
requirements that tie consumer
protections to licensing requirements,
the consumer protections are not
necessarily preempted. As we explained
in the proposal, under section 709(b)(4)
of FDARA, a State or local government
cannot require persons engaged in
commercial activity involving OTC
hearing aids to undertake special
licensing or equivalent activities solely
on that basis (see 86 FR 58150 at 58158).
However, such persons who voluntarily
identify as a licensed person would be
subject to corresponding State or local
requirements for such licensed persons,
including consumer protection
requirements, to the extent that the State
or local requirements do not restrict or
interfere with commercial activity
involving OTC hearing aids (see section
709(b)(4) of FDARA; see also the
discussion in 86 FR 58150 at 58158).
Therefore, the issue is not necessarily
that the consumer protections are
preempted, but rather the issue is that
the consumer protections are tied to the
licensing requirements. Thus, to the
extent that consumers purchase OTC
hearing aids from non-licensed persons,
they may not get the additional
consumer protections they would get if
they purchased the OTC hearing aid
from a licensed person. However,
Congress made clear that any State or
local requirement for the involvement or
intervention of a licensed person for
consumers to access OTC hearing aids is
preempted under section 709(b)(4) of
FDARA. Even if certain consumer
protections are not required as part of
the sale of OTC hearing aids by nonlicensed persons, we do not believe that
consumers who purchase OTC hearing
aids from non-licensed persons will be
left without consumer protections. In
addition to consumer protection laws
administered by the Federal Trade
Commission, many States have
generally applicable consumer
protection requirements that would not
be preempted under section 709(b)(4) of
FDARA, such as those that address
unfair and deceptive business practices,
false or misleading advertising,
warranties, etc.
(Comment 123) A comment suggested
that FDA preempt State requirements
for hearing aids as they apply to OTC
hearing aids but that such requirements
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should continue to apply to prescription
hearing aids. Another comment
expressed concern that State hearing aid
laws that are not severable could be
preempted as applied to all hearing
aids.
(Response) If a State requirement does
not fall within section 709(b)(5) of
FDARA and is preempted under section
709(b)(4) of FDARA, FDA would
consider it to be preempted to the extent
that it applies to OTC hearing aids. Such
State requirement may continue to
apply to prescription hearing aids
unless the requirement is preempted
under section 521 of the FD&C Act.
(Comment 124) A comment noted that
there are State statutes and rules that
refer to §§ 801.420 and 801.421 or
incorporate the same or similar language
contained in those provisions, and
requested input on whether such State
laws would continue to apply or
whether they would be preempted by
the new Federal rules. The comment
also encouraged FDA to consider using
the existing sections to capture the new
labeling requirements or special
controls because using the existing
sections may be beneficial for State laws
that refer to those sections.
(Response) State laws or rules that
incorporate language that is the same as,
or substantially identical to, the
language contained in former § 801.421
may continue in effect as applied to
prescription hearing aids. However, one
exception is the statement that was
required under § 801.421(a)(2)(iii).
Specifically, § 801.421(a)(2)(iii) required
that the hearing aid dispenser affords
the prospective user the opportunity to
sign the following statement: ‘‘I have
been advised by (Hearing aid
dispenser’s name) that the Food and
Drug Administration has determined
that my best health interest would be
served if I had a medical evaluation by
a licensed physician (preferably a
physician who specializes in diseases of
the ear) before purchasing a hearing aid.
I do not wish a medical evaluation
before purchasing a hearing aid.’’ State
or local laws or rules that require this
statement would no longer be in effect
because this statement was based on the
waiver of the medical evaluation that
was required under § 801.421, which
FDA is repealing.
Because § 801.420 was issued under
section 520(e) of the FD&C Act (among
other authorities), and FDA is not
relying on this authority for the revised
labeling requirements for prescription
hearing aids, FDA has decided to
establish the revised labeling
requirements in new § 801.422. In the
labeling requirements for prescription
hearing aids in § 801.422, FDA has
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retained in substance most of the
labeling requirements that were in
§ 801.420 but also made some revisions.
Whether State hearing aid labeling
requirements that incorporate language
from § 801.420 are preempted as applied
to prescription hearing aids due to the
new labeling requirements in § 801.422
depends on whether they are different
from, or are in addition to, the new
requirements. If they are equal to, or
substantially identical to, the
requirements in § 801.422, they would
not be preempted as applied to
prescription hearing aids. See
§ 808.1(d)(2). State hearing aid labeling
requirements incorporating language
from § 801.420 would be preempted as
applied to OTC hearing aids if they are
different from, in addition to, or
otherwise not identical to, the OTC
hearing aid labeling requirements in
§ 800.30. See section 709(b)(4) of
FDARA.
We note that the requirements in
§§ 801.420 and 801.421 were considered
general controls that applied to all
hearing aids regardless of the device’s
classification. In other words, these
requirements were not special controls
under section 513(a)(1)(B) of the FD&C
Act. Similarly, the labeling
requirements for prescription hearing
aids in § 801.422 are considered general
controls that apply to all prescription
hearing aids regardless of the device’s
classification. Special controls apply to
class II devices and the special controls
for a class II hearing aid are specified in
the particular classification for the
hearing aid (e.g., § 874.3305).
(Comment 125) Comments requested
that FDA clarify the types of State or
local requirements for an audiological or
medical evaluation, prior to purchasing
a prescription hearing aid, that this rule
would not preempt. Many of these
comments conveyed uncertainty about
the effects on existing State and local
requirements with the withdrawal of
previous exemption decisions that
allowed States and localities to establish
and continue in effect requirements
respecting hearing aids.
(Response) State or local requirements
that were preempted solely because they
differed from or were in addition to the
conditions for sale requirements in
§ 801.421 and for which FDA previously
granted exemptions from Federal
preemption may continue in effect with
respect to prescription hearing aids after
the withdrawal of the previous
exemption decisions. This is because
State or local requirements are
preempted under section 521(a) of the
FD&C Act only when FDA has
established specific counterpart
regulations or there are other specific
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requirements applicable to a particular
device that make State or local
requirements applicable to the device
different from, or in addition to, the
specific Federal requirements (see
§ 808.1(d)). The repeal of § 801.421 will
remove this specific counterpart
regulation that currently makes State or
local requirements different from, or in
addition to, the specific Federal
requirements therein. As such, the State
requirements that were preempted
solely because they differed from or
were in addition to the requirements in
§ 801.421 and for which FDA previously
granted exemptions will no longer be
preempted under section 521(a) of the
FD&C Act. They may therefore continue
in effect for prescription hearing aids,
without an exemption, so FDA is
removing the exemption decisions that
will become unnecessary.
As a result, if a State establishes or
continues in effect a requirement that,
for example, people younger than 18
must have a medical evaluation by an
ear-nose-throat doctor to obtain a
prescription hearing aid, then that
requirement would, as a general matter,
no longer be ‘‘different from, or in
addition to,’’ the examination and
waiver requirements in § 801.421 that
we are repealing. Similarly, a State
could establish or continue in effect a
requirement, for example, that a
licensed hearing instrument specialist
refer an adult prescription hearing aid
candidate for a medical examination if
the specialist observes a Red Flag
condition. However, a State could not
establish or continue in effect such a
referral requirement for OTC hearing
aids, as explained elsewhere in this
document.
Additionally, as explained elsewhere
in this document, FDA is revising the
labeling requirements in § 801.420 by,
among other things, moving them to
new § 801.422 and applying them to
prescription hearing aids. State or local
requirements with respect to
prescription hearing aids that differ
from, or are in addition to, the
requirements in § 801.422 would be
preempted under section 521(a) of the
FD&C Act.
I. Repeal of Restrictions and
Modifications for Prescription Labeling
(§§ 801.420, 801.421, 801.422)
Many comments related to repealing
the conditions for sale for hearing aids
expressed concerns for maintaining the
involvement of a licensed person in the
adoption and use of hearing aids. One
result of this rulemaking is that nonOTC air-conduction hearing aids will be
prescription hearing aids, which will
require the order (prescription) of a
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practitioner licensed by State law, as we
explain elsewhere in this document.
Thus, the repeal of § 801.421 does not
imply the removal of a licensed person
from hearing health care with respect to
prescription hearing aids.
Other comments communicated a
desire for regulatory consistency and/or
continuity. While FDA would agree
these are legitimate interests, we
generally declined to maintain the
restrictions on those bases. However, we
note that final § 801.422 retains many of
the labeling requirements under
§ 801.420, and we have made the
labeling requirements for prescription
hearing aids consistent with that for
OTC hearing aids to the extent
appropriate.
(Comment 126) One comment
expressed concern that with the repeal
of the hearing aid restrictions, the
previous preemption decisions would
no longer apply. The comment stated
that while many State laws that had
been denied an exemption have since
been repealed, some unrepealed laws
that have been unenforceable would
now be enforceable, including those that
would restrict and/or impede the sale of
hearing aids.
(Response) FDA is repealing § 801.421
which sets forth the conditions for sale
of hearing aids, and revising the labeling
requirements under § 801.420 by, among
other things, applying them to
prescription hearing aids only and
moving them to new § 801.422. We
assume that the comment is referring to
the repeal of § 801.421 given that the
labeling requirements, although revised
and moved to new § 801.422, would
continue to exist and apply to
prescription hearing aids. FDA is
repealing § 801.421 because the Agency
believes these requirements are no
longer necessary to provide reasonable
assurance of safety and effectiveness of
prescription hearing aids. FDA had been
exercising enforcement discretion by
generally not enforcing most of the
requirements in § 801.421 since late
2016. Additionally, we note that
prescription hearing aids will require a
written or oral authorization from a
practitioner licensed by law to
administer the device (see § 801.109).
This requirement, along with the
revised labeling requirements for
prescription hearing aids, will help
provide reasonable assurance of safety
and effectiveness of these devices. State
or local requirements that were
previously preempted under section 521
of the FD&C Act solely on the basis that
they were different from, or were in
addition to, the requirements in
§ 801.421 would no longer be
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preempted as applied to prescription
hearing aids.
We note that State or local
requirements would be preempted
under section 709(b)(4) of FDARA if
they: specifically related to hearing
products; would restrict or interfere
with the sale of, or other commercial
activity involving, OTC hearing aids; are
different from, in addition to, or
otherwise not identical to, the OTC
Hearing Aid Controls; and do not fall
within section 709(b)(5) of FDARA.
(Comment 127) Several comments
proposed that prescription hearing aids
remain restricted devices. Many of these
comments expressed concerns about the
role of licensed persons in fitting and
dispensing hearing aids, and a desire to
ensure that prescription hearing aids
would only be sold pursuant to the
written authorization of a qualified
hearing aid professional or, in some
cases, a physician specifically. Such
comments, sometimes referring to
‘‘special controls,’’ also sought to retain
oversight of licensed persons.
(Response) Although FDA agrees that
the selection and use of prescription
hearing aids should involve a licensed
person, we are not maintaining the
device restrictions because the
restrictions are unnecessary to ensure
the involvement of a licensed person in
the use of prescription hearing aids.
Under final § 800.30(b), a prescription
hearing aid is one that does not meet the
definition of ‘‘over-the-counter hearing
aid’’ or does not meet the requirements
of the OTC Hearing Aid Controls. Any
hearing aid that is not OTC is a
prescription device. A prescription
hearing aid is subject to § 801.109
regarding prescription devices
(explained in the proposal, 86 FR 58150
at 58168). Among other requirements,
§ 801.109 specifies that prescription
devices are those to be sold only to or
on the prescription or other order of a
practitioner licensed by law to use or
order the use of the devices in the
course of professional practice (see
§ 801.109(a)(2)). Further, § 801.109
requires labeling indicating that the
device is only for prescription use (see
§ 801.109(b)(1)). A prescription hearing
aid that lacks this labeling would be
misbranded (see final § 801.422(c)(6)).
Marketing a misbranded device, for
example, by introducing it into
interstate commerce, and other activities
with respect to misbranded devices are
prohibited acts (see, e.g., 21 U.S.C.
331(a)–(c), 331(k)).
FDA notes that, in some
circumstances, requirements on
prescription hearing aids once this rule
is in effect may be more stringent than
under former § 801.421 which allowed a
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50741
prospective hearing aid user 18 or older
to waive the requirement for a medical
evaluation (former § 801.421(a)(2)).
Further, as we explained in the
proposal, FDA had expressed that we do
not intend to enforce the medical
evaluation, waiver, or recordkeeping
requirements with respect to
prospective purchasers who are 18 or
older (see 86 FR 58150 at 58154).
However, once this rule repeals those
restrictions, any hearing aid that meets
the definition of a prescription hearing
aid will be subject to requirements for
prescription devices, such as those in
§ 801.109(a)(2). That is, such devices
may be sold only to or on the
prescription or other order of a licensed
practitioner. We also note that States,
not FDA, generally determine the
licensing requirements for practitioners
to use or order the use of a prescription
device. Thus, States may, for example,
require that prescription hearing aids be
ordered by physicians (medical doctors)
or audiologists, which may involve a
medical or audiological evaluation of
the prospective user, including someone
who is 18 or older. (See also the
response to Comment 128.)
(Comment 128) A few comments
suggested that FDA apply device
restrictions to OTC hearing aids. A
comment suggested that FDA make both
OTC and prescription hearing aids
restricted devices. The comment argued
this would ensure regulatory
consistency between categories as well
as supporting complementary State and
local consumer protections.
(Response) FDA is declining to take
these suggestions. We are not making
OTC hearing aids restricted devices
under section 520(e) of the FD&C Act,
and we are repealing the existing
restrictions on hearing aids. For OTC
and prescription hearing aids, at this
time we believe the authorities that we
are relying on, including those
described in section IV of this
document, are adequate. Because we are
not relying on our restricted device
authority at this time, neither OTC
hearing aids nor prescription hearing
aids would be restricted devices under
section 520(e) of the FD&C Act.
Therefore, there would be regulatory
consistency between these categories in
this respect.
Further, to the extent the comment is
requesting that FDA maintain the
restrictions in § 801.421, the restrictions
that we are repealing do not in
themselves enable or support
complementary State and local
consumer protections. Indeed, many of
the State requirements for hearing aids
for which FDA had granted exemptions
from Federal preemption were
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preempted because of the restrictions
(they were different from, or were in
addition to, the restrictions), and the
State requirements continued in effect
because the States applied for, and FDA
granted, exemptions. Absent the
restrictions, those State requirements,
many of which related to patient or
consumer protection, likely would not
have been preempted (all else being
equal) and could have continued in
effect without FDA acting to exempt
them.
Moreover, section 709(b)(4) of FDARA
would continue to apply to OTC hearing
aids and, as described elsewhere, would
still preempt certain State and local
requirements pertaining to a wide range
of commercial activity involving OTC
hearing aids, regardless of whether or
not OTC hearing aids are restricted
devices. Additionally, FDA would not
expect that making OTC hearing aids
restricted devices would augment State
and local consumer protections that
would continue in effect. (See also the
response to Comment 127.)
(Comment 129) Some comments
proposed that prescription hearing aids
remain restricted devices to ensure that
FDA retain the added regulatory
authority over advertising material for
restricted devices. These comments
asserted that advertising has falsely or
misleadingly suggested that products
were hearing aids, inducing people to
use products that were not safe or
effective options to address or
compensate for hearing loss. The use of
unsafe or ineffective products, instead
of hearing aids, has an increased risk of
impairing the user’s remaining hearing
or convincing users not to seek safer,
more effective options.
(Response) FDA is not accepting this
proposal because as explained in the
response above, at this time we believe
the authorities that we are relying on,
including those described in section IV
of this document, are adequate.
Additionally, restricted device
authority is not necessary for FDA
regulation of products that are marketed
as hearing aids but do not comply with
applicable requirements. The intended
use of an article (not just restricted
devices) may be shown by, among other
indicia, the circumstances surrounding
distribution as well as advertising
matter (see § 801.4). Should such
circumstances or advertising show that
the article is intended to compensate for
hearing loss, then it would be subject to
labeling and other requirements for
hearing aids. Failure to meet these
requirements would render the article
adulterated and/or misbranded (see 21
U.S.C. 351 and 352). Marketing (for
example, by introducing such articles
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into interstate commerce) and other
activities with respect to such articles
would constitute prohibited acts even
though prescription hearing aids would
not be restricted devices (see, e.g., 21
U.S.C. 331(a)–(c), 331(k)).
(Additional Revision 5) FDA has
identified additional revisions that
would provide for clarity and
consistency upon the removal of
§ 801.420 and the repeal of § 801.421.
We proposed to amend § 874.3950 (21
CFR 874.3950), the classification
regulation for transcutaneous airconduction hearing aid systems, by
specifying that the devices would be
subject to new § 801.422. This would
clarify that the devices are prescription
hearing aids and subject to
corresponding labeling requirements.
However, the regulation currently
specifies that transcutaneous airconduction hearing aid systems are
subject to special controls described by
the document, ‘‘Class II Special Controls
Guidance Document: Transcutaneous
Air Conduction Hearing Aid System
(TACHAS); Guidance for Industry and
FDA,’’ issued on November 7, 2002 (see
§ 874.3950(b)).16 That document in turn
currently refers to §§ 801.420 and
801.421. Further, in reviewing the
document for consistency with this
rulemaking, we observed that its Scope
section refers incorrectly to § 874.3340,
which is not the correct citation for the
classification regulation for
transcutaneous air-conduction hearing
aid systems.
For clarity and consistency, in
addition to the amendment that we
proposed to § 874.3950(a), we are
revising the special controls document
by replacing references to §§ 801.420
and 801.421 with § 801.422 for both. We
also are correcting the reference to the
incorrect classification regulation to the
correct one, which is § 874.3950. To
indicate these revisions, we are adding
a statement to the special controls
document that we revised the
document. We will publish the special
controls document with the revisions on
or around the effective date of this final
rule. However, we are not revising the
substance of the special controls
document, and as such, we are not
updating the date on which the
document was issued. The revisions to
the special controls document will
appear on FDA’s website.
16 The document is available online at: https://
www.fda.gov/medical-devices/guidancedocuments-medical-devices-and-radiation-emittingproducts/transcutaneous-air-conduction-hearingaid-system-tachas-class-ii-special-controlsguidance-document.
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J. Other Amendments
(Comment 130) One comment
suggested that FDA include a
misbranding provision for OTC hearing
aids with respect to labeling, similar to
the provision included for prescription
hearing aids (final § 801.422(c)(6)).
(Response) FDA declines to include a
similar misbranding provision for OTC
hearing aids under § 800.30. As
provided in §§ 800.30(a) and (b) and
801.422(a) and (b), any hearing aid that
does not satisfy the requirements of
§ 800.30, including the labeling
requirements of that section, is a
prescription hearing aid, and as such,
must meet the requirements of
§§ 801.422 and 801.109. In other words,
a hearing aid that fails to meet the
labeling requirements of § 800.30 would
be subject to §§ 801.422 and 801.109. In
turn, failure to meet the labeling
requirements of §§ 801.422(c) and
801.109 would render the product
misbranded, as stated in final
§ 801.422(c)(6). In other words, hearing
aids that fail to comply with the
requirements in § 800.30 would be
prescription hearing aids and would be
misbranded if they fail to comply with
§§ 801.422 and 801.109. For example,
such a hearing aid would be misbranded
under section 502(f)(1) of the FD&C Act
in that its labeling would fail to bear
adequate directions for use and it would
not be exempt from this requirement.
(Comment 131) A comment proposed
that FDA develop a national standard to
sell prescription hearing aids via
telemedicine visits with licensed
persons to people who are 18 years of
age or older. The comment suggested
that the standard could include
calibrated in-home tests for both airconduction and bone-conduction
devices.
(Response) Although FDA establishes
performance standards for devices,
among other general and special
controls, in appropriate circumstances,
FDA does not generally establish
standards for medical practice,
including telemedicine. However, we
note that in-home hearing tests may
meet the definition of ‘‘device’’ and be
subject to the provisions of, and
regulatory controls under, the FD&C
Act, including those described in
section IV of this document.
Classification of a hearing test would
establish the controls necessary to
provide reasonable assurance of safety
and effectiveness of the device for its
intended use(s), and these would apply
to the devices nationally. (See also
section X describing the implications of
federalism.)
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(Additional Revision 6) FDA has
decided not to realign the classification
regulations by sound conduction mode
as proposed. Combining the existing
regulations may have suggested to
stakeholders that only a single device
type was appropriate for OTC
availability or vice versa. However, as
explained elsewhere, for example, in the
response to Comment 2, that is not the
case. To reduce the potential for this
kind of confusion, we are keeping the
various air-conduction generic types in
their existing regulations. However, we
are proceeding to separate boneconduction hearing aids into their own
classification regulation, new
§ 874.3302, including the reassignment
of product codes. We are also
proceeding with the other proposed
minor revisions to the air-conduction
classification regulations, including the
revisions to the special controls as
provided in proposed § 874.3305(b) and
clarifying the applicability of
requirements under either final § 800.30
or § 801.422 for the various generic
types.
VI. Effective and Compliance Dates
(Comment 132) FDA received several
comments proposing that the
compliance date be the same for hearing
aids that have and have not been offered
for sale prior to the effective date of this
final rule. These comments provided
various reasons, including that: new
entrants into the hearing aid market
need time to make pre-launch
adjustments to their marketing and
devices they plan to introduce and need
more than the 60 days proposed; that
FDA takes longer than 60 days to review
510(k)s; and that different compliance
dates for different manufacturers would
be unfair. Most such comments
proposed a compliance date of 240 days
after the publication of this final rule.
(Response) FDA is not establishing
the same compliance dates because
hearing aids that are not offered for sale,
that is, not on the market, are not
similarly situated as hearing aids offered
for sale, that is, on the market, prior to
the effective date. The compliance date
is not the date by which new entrants
must start marketing, and if new
entrants find they need additional time
prior to marketing their devices, they
may take it. Moreover, should a new
entrant need to obtain 510(k) clearance,
it could not market the device until it
obtains clearance, regardless of the
compliance date.
We acknowledge that hearing aids on
the market will have a different
timeframe for compliance. However, the
consequences of noncompliance with
the new requirements are different for
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hearing aids that are on the market from
those not on the market when this rule
takes effect. For hearing aids that are on
the market, they are subject to
enforcement actions if they do not
comply with the new requirements as
well as other applicable requirements.
Given this, they need sufficient time to
come into compliance. Hearing aids that
are not on the market do not face these
consequences—as discussed above, if
such hearing aids do not comply with
the new requirements and other
applicable requirements, manufacturers
may take whatever time they need to
bring the devices into compliance. As
such, the same compliance timeframe is
not appropriate in this case. See the
response to Comment 133 about
considerations for 510(k)s for marketed
devices.
(Comment 133) Some comments
regarding marketed devices also raised
concerns that FDA may take too long to
review 510(k)s, and devices could be
out of compliance even if a
manufacturer submitted a 510(k) soon
after the publication of this final rule.
They sought clarification and/or a
change in the compliance date.
(Response) In consideration of the
comments, for hearing aids legally
offered for sale prior to the effective
date, FDA intends not to enforce the
requirement for a 510(k) in certain
situations, as discussed in the
compliance date section below.
(Comment 134) Some comments
questioned how soon hearing aids could
be made available OTC, including
whether manufacturers would need to
wait 60 days (until the effective date).
(Response) Generally, hearing aids
could not be available OTC within the
meaning of section 520(q)(1)(A)(v) of the
FD&C Act until the effective date of this
final rule.
A. Effective Date
This final rule will be effective 60
days after the publication in the Federal
Register. We are finalizing the following
compliance dates:
B. Compliance Date for Hearing Aids
Not Legally Offered for Sale Prior to the
Effective Date
For hearing aids that have not been
offered for sale prior to the effective date
of the final rule, or have been offered for
sale but are required to submit a new
510(k) under § 807.81(a)(3) due to
changes unrelated to this rule (an
example of such is the addition of selffitting technology to a wireless airconduction hearing aid), compliance
with the new or revised requirements
applicable to the hearing aid, and
obtaining 510(k) clearance if applicable,
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50743
must be achieved before marketing the
device on or after the effective date of
this final rule. If a person (e.g.,
manufacturer) markets such a device
without complying with the new or
revised requirements or if applicable,
obtaining 510(k) clearance, then FDA
would consider taking action against
such person under our usual
enforcement policies.
C. Compliance Date for Hearing Aids
Legally Offered for Sale Prior to the
Effective Date
For hearing aids that have been
legally offered for sale prior to the
effective date of the final rule, including
those that already have a 510(k)
clearance, compliance with the new or
revised requirements that apply to the
hearing aid must be achieved 180 days
after the effective date of the final rule
(i.e., 240 days after the publication of
the final rule). After that date, if a
person (e.g., manufacturer) continues to
market such a device but does not
comply with the new or revised
requirements that apply to the device,
then FDA would consider taking action
against such person under our usual
enforcement policies.
However, FDA does not intend to
enforce the requirement to submit a
510(k) and obtain 510(k) clearance
where a hearing aid is legally offered for
sale prior to the effective date; the
changes that require a new 510(k) are
made on or before the compliance date
and are made solely to satisfy the OTC
Hearing Aid Controls; the changes do
not adversely affect device safety or
effectiveness; the device is otherwise in
compliance with applicable
requirements; and on or before the
compliance date, the manufacturer
documents the changes and its
determination that the changes do not
adversely affect device safety or
effectiveness.
At present, legacy and wireless airconduction hearing aids are exempt
from section 510(k) (21 U.S.C. 360(k)) of
the FD&C Act, subject to the limitations
of exemption described in § 874.9.
(Legacy hearing aids are class I devices
and are 510(k) exempt under section
510(l)(1) of the FD&C Act.) See the
response to Comment 5 for more about
considerations for when to submit a
510(k).
VII. Economic Analysis of Impacts
We have examined the impacts of this
final rule under Executive Order 12866,
Executive Order 13563, the Regulatory
Flexibility Act (5 U.S.C. 601–612), and
the Unfunded Mandates Reform Act of
1995 (Pub. L. 104–4). Executive Orders
12866 and 13563 direct us to assess all
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costs and benefits of available regulatory
alternatives and, when regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety,
and other advantages; distributive
impacts; and equity). This rule is an
economically significant regulatory
action as defined by Executive Order
12866.
The Regulatory Flexibility Act
requires us to analyze regulatory options
that would minimize any significant
impact of a rule on small entities.
Because the estimated annualized cost
over 10 years is $0.009 million per firm,
which is unlikely to represent more
than three percent to five percent of the
revenue of an affected manufacturer, we
certify that this final rule will not have
a significant economic impact on a
substantial number of small entities.
The Unfunded Mandates Reform Act
of 1995 (section 202(a)) requires us to
prepare a written statement, which
includes an assessment of anticipated
costs and benefits, before proposing
‘‘any rule that includes any Federal
mandate that may result in the
expenditure by State, local, and tribal
governments, in the aggregate, or by the
private sector, of $100,000,000 or more
(adjusted annually for inflation) in any
one year.’’ The current threshold after
adjustment for inflation is $165 million,
using the most current (2021) Implicit
Price Deflator for the Gross Domestic
Product. This final rule will result in an
expenditure in at least one year that
meets or exceeds this amount.
This rule defines a new regulatory
category for OTC hearing aids and
makes corresponding changes to the
existing regulatory framework,
including defining hearing aids not
meeting the OTC requirements as
prescription medical devices, as well as
providing new labeling requirements for
both OTC and prescription hearing aids.
This rule would generate potential cost
savings for consumers with perceived
mild to moderate hearing impairment
who wish to buy lower cost hearing aids
not bundled with professional services
and not requiring professional advice,
fitting, adjustment, or maintenance but
who are currently unable to buy such
products online because of State
regulations or because they do not shop
online. This rules also generates costs
for hearing aid manufacturers for
changing labeling of existing hearing
aids as well as for reading the rule and
revising internal standard operating
procedures in response to the rule.
Table 1 summarizes our estimate of the
annualized costs and the annualized
benefits of this final rule.
TABLE 1—SUMMARY OF BENEFITS, COSTS AND DISTRIBUTIONAL EFFECTS OF FINAL RULE
Units
Category
Benefits:
Annualized Monetized $millions/year .....................
Annualized Quantified ............................................
Qualitative ..............................................................
Costs:
Annualized Monetized $millions/year .....................
Annualized Quantified ............................................
Qualitative ..............................................................
JSPEARS on DSK121TN23PROD with RULES2
Transfers:
Federal Annualized Monetized $millions/year .......
Primary
estimate
Low
estimate
High
estimate
$63
63
..................
$6
6
..................
$147
147
..................
2020
2020
..................
7
3
7
3
10
10
..................
Potential increase in hearing aid and
hearing technology use, leading to
associated health benefits, potential
fostering of innovation in hearing aid
technology. Potential increase in
consumer utility, derived from reduced
health risks, from inability to buy some
existing hearing aids under existing
conditions.
..................
..................
..................
1
1
..................
2
2
..................
2020
2020
..................
7
3
7
3
10
10
..................
Potential loss of consumer utility from
inability to buy existing hearing aids
under existing conditions, including
consumers of online hearing aids that
do not meet OTC requirements. Costs
to manufacturers of hearing aids sold
online that do not meet OTC
requirements to render their products
and sales methods consistent with the
requirements of either OTC or
prescription hearing aids.
..................
..................
..................
..................
..................
7
3
..................
7
3
..................
From/To ..................................................................
From:
Other Annualized Monetized $millions/year ...........
..................
From/To ..................................................................
From:
1
1
..................
..................
..................
Year
dollars
Discount
rate
(%)
Period
covered
(years)
To:
..................
..................
..................
To:
Effects:
State, Local or Tribal Government:
Small Business:
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Notes
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TABLE 1—SUMMARY OF BENEFITS, COSTS AND DISTRIBUTIONAL EFFECTS OF FINAL RULE—Continued
Units
Primary
estimate
Category
Low
estimate
High
estimate
Discount
rate
(%)
Year
dollars
Period
covered
(years)
Notes
Wages:
Growth:
Distributional effects are also possible that would favor general retailers and new manufacturers entering into the hearing aid market who do not have relations
with current specialty retail suppliers and disfavor specialty retail suppliers and associated workers including hearing healthcare professionals, and established
manufacturers with relations with those suppliers.
We have developed a comprehensive
Economic Analysis of Impacts that
assesses the impacts of this rule. The
full analysis of economic impacts is
available in the docket for this rule (Ref.
16) and at https://www.fda.gov/aboutfda/reports/economic-impact-analysesfda-regulations.
VIII. Analysis of Environmental Impact
FDA has carefully considered the
potential environmental impact of this
final rule and of possible alternative
actions. In doing so, the Agency focused
on the environmental impacts of its
action as a result of increased use and
eventual disposal of OTC hearing aids
that will need to be handled after the
effective date of this final rule.
The environmental assessment (EA)
considers environmental impacts
related to additional waste to landfills at
municipal solid waste (MSW) facilities.
The selected action will likely increase
the availability and use of hearing aid
devices, which would result in
additional waste from increased
disposal of these devices and their
associated batteries, as well as an
increase in industrial waste associated
with any domestic production to meet
market demand for the new devices.
Overall, given the current limited use of
these devices, projected slow growth
with increase in availability, and the
small mass of waste material to be
disposed or recycled, the selected action
is not expected to have a significant
impact on MSW, landfill facilities, and
the environment.
The Agency has concluded that the
final rule will not have a significant
impact on the human environment, and
that an environmental impact statement
is not required. FDA’s FONSI and the
evidence supporting that finding,
contained in an EA prepared under 21
CFR 25.40, are on display with the
Dockets Management Staff (see
ADDRESSES) and are available for
viewing by interested persons between
9 a.m. and 4 p.m., Monday through
Friday; they are also available
electronically at https://
www.regulations.gov.
IX. Paperwork Reduction Act of 1995
This final rule contains information
collection provisions that are subject to
review by OMB under the PRA (44
U.S.C. 3501–3521). The title,
description, and respondent description
of the information collection provisions
are shown in the following paragraphs
with an estimate of the annual
reporting, recordkeeping, and third-
party disclosure burden. Included in the
estimate is the time for reviewing
instructions, searching existing data
sources, gathering and maintaining the
data needed, and completing and
reviewing each collection of
information.
Title: Medical Device Labeling
Regulations; OMB Control Number
0910–0485—Revision.
Description: FDA is establishing a
regulatory category for OTC hearing aids
and making related amendments to
update the regulatory framework for
hearing aids. Among other amendments
described in this rulemaking, we amend
the existing labeling requirements for
hearing aids. In creating a regulatory
category for OTC hearing aids and
amending existing rules, we intend to
provide reasonable assurance of safety
and effectiveness for hearing aids as
well as foster access to, and innovation
in, hearing aid technology, thereby
protecting and promoting the public
health.
Description of Respondents:
Respondents to the information
collection are manufacturers of hearing
aids.
We estimate the burden of the
collection of information as follows:
TABLE 2—ESTIMATED ONE-TIME BURDEN 1 2
Number of
recordkeepers
Activity
Understanding and implementing new regulatory requirements from hearing aids rule ................................................
Hearing aids relabeling .............................................................
1 There
Number of
records per
recordkeeper
105
105
Total annual
records
1
8
Average
burden per
recordkeeping
105
840
290
68
Total hours
30,450
57,120
Total capital
costs
$4,100,000
6,000,000
are no operating and maintenance costs associated with this collection of information.
have been rounded to the nearest whole number.
2 Numbers
TABLE 3—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2
Number of
recordkeepers
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Activity; 21 CFR section
Labeling
disclosures
under
800.30(c)(2)
and
801.422(c)(2); Hearing aids; electronic version of user
instructional brochure .......................................................
1 There
Number of
records per
recordkeeper
105
Total annual
records
8
840
are no operating and maintenance costs associated with this collection of information.
have been rounded to the nearest whole number.
2 Numbers
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Average
burden per
recordkeeping
1
Total hours
840
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TABLE 4—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 2
Number of
respondents
Activity; 21 CFR section
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
OTC Hearing Aid Controls—800.30 ....................................
Prescription Hearing Aid Labeling—801.422 .......................
105
105
7
1
735
105
19
19
13,965
1,995
Total ..............................................................................
........................
........................
........................
........................
15,960
1 There
are no operating and maintenance costs associated with this collection of information.
have been rounded to the nearest whole number.
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2 Numbers
Our burden estimate is based on FDA
Uniform Registration and Listing
System data; FDA’s Operational and
Administrative System for Import
Support data; informal communications
with industry; and our knowledge of
and experience with information
collection pertaining to medical device
labeling. We intend the burden
estimates to be consistent with our Final
Regulatory Impact Analysis (FRIA) for
this rulemaking (Ref. 16).
Estimated One-Time Burden:
Understanding and implementing new
regulatory requirements from hearing
aids rule—one-time burden
(Recordkeeping): As noted in the FRIA
for this rulemaking, we estimate it will
take 5 hours each for an executive, a
lawyer, and a marketing manager to read
and understand the rule. Also included
in our estimate is time for revising
guidelines or standard operating
procedures. We assume this may take
up to 25 hours for one executive, up to
100 hours for one marketing manager,
and up to 150 hours for one technical
writer. Therefore, we estimate a onetime recordkeeping burden of 290 hours
for each manufacturer.
Hearing aids relabeling—one-time
burden (Third-Party Disclosure): The
rulemaking necessitates the relabeling of
all current hearing aids (approximately
840). The labeling cost model used in
the FRIA suggests, based on a
compliance date 240 days after
publication of the final rule, a one-time
estimated third-party disclosure burden
for relabeling of about 68 hours per
product.
Estimated Annual Burden: Over-theCounter Hearing Aid Controls—§ 800.30
(Recordkeeping and Third-Party
Disclosure): Section 800.30 sets forth
labeling requirements for OTC hearing
aids. Section 800.30(c)(1) describes the
warnings and other important
information that the outside package
must bear. Manufacturers must include
on the outside package label: certain
specified warnings and statements; a
weblink to all labeling and any
additional resources; contact
information to request a paper copy of
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the labeling; their return policy or
absence thereof; if the OTC hearing aid
is used or rebuilt, they must declare that
fact; the principal display panel must
bear the marks ‘‘OTC’’ and ‘‘hearing
aid’’; battery information; and control
platform information if applicable.
Section 800.30(c)(2) describes devicespecific requirements for labeling,
inside the package. Among the labeling
requirements listed are a user
instructional brochure, an electronic
version of which is to be made available
for download; additional warnings;
caution and notices for users; other
specified information; and any other
information necessary for adequate
directions for use as defined in § 801.5.
Also required under proposed
§ 800.30(c)(2) is the identification of any
known physiological side effects
associated with the use of the OTC
hearing aid that may warrant
consultation with a physician; the
technical specifications required by
§ 800.30(c)(4); a description of
commonly occurring, avoidable events
that could adversely affect or damage
the OTC hearing aid; if applicable,
information relating to electromagnetic
compatibility and wireless technology
and human exposure to non-ionizing
radiation; information regarding repair
service or replacements; and, if
applicable, a summary of all clinical or
non-clinical studies conducted to
support the performance of the OTC
hearing aid.
Section 800.30(c)(3) provides
requirements for the labeling on an OTC
hearing aid itself, specifically, serial
number, information regarding the
battery and, if the OTC hearing aid is
used or rebuilt, the manufacturer must
physically attach a removable tag to the
hearing aid declaring that fact.
Section 800.30(c)(5) provides
requirements related to software device
labeling.
We include no estimate for provisions
under proposed § 800.30(c)(1)(i)(A)
through (D), (c)(2)(i)(A) through (C), and
(c)(2)(iii)(A) through (F) because we
consider the labeling to be ‘‘public
disclosure of information originally
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supplied by the Federal government to
the recipient for the purpose of
disclosure to the public,’’ consistent
with 5 CFR 1320.3(c)(2). Thus, those
labeling provisions are not within the
definition of collection of information.
The FRIA for this rulemaking
estimates that 105 firms manufacture
air-conduction hearing aids sold in the
United States, based on FDA Medical
Device Registration data. We estimate
that each manufacturer has an average
of eight products that would need
relabeling.
For each hearing aid product, we
assume a 1-hour annual recordkeeping
burden for maintaining the electronic
version of the user instructional
brochure (under §§ 800.30(c)(2) and
801.422(c)(2)).
The rulemaking would necessitate the
relabeling of all current hearing aids
(approximately 840) according to either
the OTC or prescription hearing aid
labeling requirements. While we lack
specific data regarding what portion of
hearing aids will be relabeled as
prescription devices and what portion
will be relabeled as OTC hearing aids,
for this analysis, we assume that 10
percent will be relabeled as prescription
medical devices (about 1 product per
manufacturer) and 90 percent as OTC
hearing aids (about 7 products per
manufacturer). The labeling cost model
used in the FRIA suggests an annual
estimated third-party disclosure burden
of about 19 hours per product.
Prescription Hearing Aid Labeling—
§ 801.422 (Third-Party Disclosure):
Section 801.422(c) sets forth labeling
requirements for prescription hearing
aids. However, as with some of the
provisions under proposed § 800.30(c),
we include no estimate for provisions
under § 801.422(c)(1)(i)(A) through (C),
(c)(2)(i)(A) through (C), and (c)(2)(ii)(A)
through (F) because we consider the
labeling to be ‘‘public disclosure of
information originally supplied by the
Federal government to the recipient for
the purpose of disclosure to the public,’’
consistent with 5 CFR 1320.3(c)(2).
Section 801.422(c)(1) provides the
warnings and notice that must be on the
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outside package labeling; if applicable,
that the prescription hearing aid is used
or rebuilt; battery information; and if
applicable, control platform
information.
Section 801.422(c)(2) describes
requirements for prescription hearing
aid labeling, inside the package. Among
the labeling requirements listed are a
user instructional brochure, an
electronic version of which is to be
made available for download; warnings;
caution and notices for users; and
additional information that must be
included in the user instructional
brochure.
Section 801.422(c)(3) provides the
requirements for the labeling on a
prescription hearing aid itself,
specifically, serial number; information
regarding the battery if applicable; and
if the prescription hearing aid is used or
rebuilt, the manufacturer must
physically attach a removable tag to the
hearing aid declaring that fact.
Section 801.422(c)(4) provides the
technical specification elements that
must appear in the user instructional
brochure or in separate labeling that
accompanies the device.
Section 801.422(c)(5) provides
requirements related to software device
labeling.
The FRIA estimates that 105 firms
manufacture air-conduction hearing
aids sold in the United States, based on
FDA Medical Device Registration data.
We estimate that each manufacturer has
an average of eight products that would
need relabeling.
For each hearing aid product, we
assume a 1-hour annual recordkeeping
burden for maintaining the electronic
version of the user instructional
brochure (under §§ 800.30(c)(2) and
801.422(c)(2)).
The rulemaking would necessitate the
relabeling of all current hearing aids
(approximately 840) according to either
the OTC or prescription hearing aid
labeling requirements. While we lack
specific data regarding what portion of
hearing aids will be relabeled as
prescription devices and what portion
will be relabeled as OTC hearing aids,
for this analysis, we assume that 10
percent will be relabeled as prescription
medical devices (about 1 product per
manufacturer) and 90 percent as OTC
hearing aids (about 7 products per
manufacturer). The labeling cost model
used in the FRIA suggests an annual
estimated third-party disclosure burden
of about 19 hours per product.
As required by section 3506(c)(2)(B)
of the PRA, FDA provided an
opportunity for public comment on the
information collection requirements of
the proposed rule.
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We received more than 1,000
comments on the proposed rule. We
describe and respond to the comments
in section V of this document,
‘‘Comments on the Proposed Rule and
FDA’s Responses.’’ Comments and
responses related to the provisions that
underlie the information collection are
described in the following sections:
III.B, regarding scope; III.D, regarding
labeling; and III.F, regarding other
device requirements. We have not made
changes to the estimated burden as a
result of those comments.
We also received a comment relating
to the information collection burden
estimate. The comment expressed
concern that, for a small business, the
‘‘cost for building a system from
scratch’’ and for reading and
understanding the rule, without a
lawyer or a marketing manager, is overly
burdensome.
Included in our estimate of 290 hours
for ‘‘Understanding and implementing
new regulatory requirements from
hearing aids rule,’’ is an average of 5
hours each for an executive, a lawyer,
and a marketing manager to read and
understand the rule. Therefore, we
estimate 15 hours for reading and
understanding the rule. We assume that
a manufacturer who does not employ a
lawyer or marketing manager, would
take approximately the same amount of
time to read and understand the rule.
This is consistent with the comment’s
statement that it took ‘‘at least 8 hours
to read through and understand this
rule.’’
While it is not clear what is meant by
‘‘building a system from scratch’’ in this
context, included in our estimate is time
for revising guidelines or standard
operating procedures. We assume this
may take up to 25 hours for one
executive, up to 100 hours for one
marketing manager, and up to 150 hours
for one technical writer; a total of 275
hours for revising guidelines or standard
operating procedures. Our estimate
assumes that, as a standard business
practice and in compliance with the
existing requirements, a company has
guidelines or standard operating
procedures in place and that the burden
estimate represents only the time to
revise existing documentation to be
consistent with the rulemaking. We
believe this estimate reflects an
appropriate amount of time for
understanding and implementing the
new regulatory requirements.
Additionally, the comment expressed
concern about the time to write ‘‘the
user instructional brochure from
scratch.’’
We have included a 68-hour, one-time
burden estimate for the relabeling
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necessitated by the rulemaking. This
estimate includes, among other things,
time for updating the user instructional
brochure and providing the required
content online. Our recordkeeping
burden estimate of 1 hour for ‘‘Labeling
disclosures under §§ 800.30(c)(2) and
801.422(c)(2); Hearing aids; electronic
version of user instructional brochure’’
is an annual estimate, intended to
reflect the maintenance of records
associated with the requirement in
§§ 800.30(c)(2) and 801.422(c)(2) to
make an electronic version of a user
instructional brochure available for
download.
We have not revised our burden
estimate based on this comment.
The information collection provisions
in this final rule have been submitted to
OMB for review as required by section
3507(d) of the Paperwork Reduction Act
of 1995.
Before the effective date of this final
rule, FDA will publish a notice in the
Federal Register announcing OMB’s
decision to approve, modify, or
disapprove the information collection
provisions in this final rule. An Agency
may not conduct or sponsor, and a
person is not required to respond to, a
collection of information unless it
displays a currently valid OMB control
number.
X. Federalism
FDA has analyzed this final rule in
accordance with the principles set forth
in Executive Order 13132. Section 4(a)
of the Executive order requires Agencies
to ‘‘construe . . . a Federal statute to
preempt State law only where the
statute contains an express preemption
provision or where there is some other
clear evidence that the Congress
intended preemption of State law, or
where the exercise of State authority
conflicts with the exercise of Federal
authority under the Federal statute.’’
Federal law includes an express
preemption provision that preempts
certain State requirements ‘‘different
from, or in addition to, any requirement
applicable under’’ the FD&C Act that is
applicable to devices. (See section 521
of the FD&C Act; Medtronic v. Lohr, 518
U.S. 470 (1996); and Riegel v.
Medtronic, 552 U.S. 312 (2008).) Federal
law also preempts State or local laws
‘‘specifically related to hearing products
that would restrict or interfere with the
servicing, marketing, sale, dispensing,
use, customer support, or distribution of
[OTC hearing aids] through in-person
transactions, by mail, or online, that
[are] different from, in addition to, or
otherwise not identical to, the
regulations promulgated under’’ section
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709(b) of FDARA (see section 709(b)(4)
of FDARA).
Section 521(b) of the FD&C Act
provides that the Commissioner of Food
and Drugs may, upon application of a
State or local government, exempt a
requirement from preemption, if the
State or local requirement for the device
is more stringent than the requirement
under the FD&C Act, or if the
requirement is necessitated by
compelling local conditions and
compliance with it would not cause the
device to be in violation of a
requirement under the FD&C Act.
Following this process, a State or local
government may request an exemption
from preemption for those State or local
requirements pertaining to hearing aid
products that are preempted by the
Agency’s final rule under section 521 of
the FD&C Act. However, because
FDARA does not provide a parallel
mechanism to exempt State or local
requirements from its express
preemption provision, FDA is not
considering exemptions under section
709(b)(4) of FDARA for OTC hearing
aids.
Thus, this final rule will create
requirements that fall within the scope
of section 521 of the FD&C Act and/or
section 709(b)(4) of FDARA. It also
amends § 801.420 and repeals § 801.421,
and such changes affect many of the
decisions on applications for exemption
from preemption that were issued in
relation to these two regulations under
section 521(b) of the FD&C Act,
resulting in the removal of the
regulations codifying such decisions, as
discussed further in section V.I. above.
The scope of preemption of this final
rule is discussed in more detail in
sections III.G through I, above.
XI. Consultation and Coordination With
Indian Tribal Governments
We have analyzed this rule in
accordance with the principles set forth
in Executive Order 13175. We have
determined that the rule does not
contain policies that would have a
substantial direct effect on one or more
Indian Tribes, on the relationship
between the Federal Government and
Indian Tribes, or on the distribution of
power and responsibilities between the
Federal Government and Indian Tribes.
Accordingly, we conclude that the rule
does not contain policies that have
tribal implications as defined in the
Executive order and, consequently, a
tribal summary impact statement is not
required.
XII. References
The following references marked with
an asterisk (*) are on display at the
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Dockets Management Staff (see
and are available for
viewing by interested persons between
9 a.m. and 4 p.m., Monday through
Friday; they are also available
electronically at https://
www.regulations.gov. References
without asterisks are not on public
display at https://www.regulations.gov
because they have copyright restriction.
Some may be available at the website
address, if listed. References without
asterisks are available for viewing only
with the Dockets Management Staff.
FDA has verified the website addresses,
as of the date this document publishes
in the Federal Register, but websites are
subject to change over time.
ADDRESSES)
1. Lin, F., J. Niparko, and L. Ferruci,
‘‘Hearing Loss Prevalence in the United
States.’’ Archive of Internal Medicine,
171:1851–1853, 2011.
2. Dalton, D.S., ‘‘The Impact of Hearing Loss
on Quality of Life in Older Adults.’’ The
Gerontologist, 43(5):661–668, 2005.
*3. National Institutes of Health (NIH).
Hearing Aids Fact Sheet. National
Institute on Deafness and
Communication Disorders. 2010.
Available at: https://www.nidcd.nih.gov/
health/statistics/quick-statistics-hearing.
4. Maharani, A., P. Dawes, et al.,
‘‘Longitudinal Relationship Between
Hearing Aid Use and Cognitive Function
in Older Americans.’’ Journal of the
American Geriatrics Society, 66(6):1130–
1136, 2018.
5. Mahmoudi, E., T. Basu, et al., ‘‘Can
Hearing Aids Delay Time to Diagnosis of
Dementia, Depression, or Falls in Older
Americans?’’ Journal of the American
Geriatrics Society, 67(11):2362–2369,
2019.
6. McCormack, A. and H. Fortnum, ‘‘Why Do
People Fitted With Hearing Aids Not
Wear Them?’’ International Journal of
Audiology, 52(5):360–368, 2013.
7. NASEM, ‘‘Hearing Health Care for Adults:
Priorities for Improving Access and
Affordability.’’ Board on Health Sciences
Policy, Committee on Accessible and
Affordable Hearing Health Care for
Adults; Blazer, D.G., S. Domnitz, and
C.T. Liverman, Eds., 2016. DOI:
10.17226/23446. Available at: https://
www.nap.edu/catalog/23446/hearinghealth-care-for-adults-priorities-forimproving-access-and.
8. ANSI/CTA 2051: Personal Sound
Amplification Performance Criteria
(voluntary consensus standard). January
2017. Available at: https://
webstore.ansi.org/standards/ansi/
cta20512017ansi.
*9. NIOSH, Occupational Noise Exposure,
publication number 98–126. June 1998.
Available at: https://www.cdc.gov/niosh/
docs/98-126/pdfs/98-126.pdf.
10. Johnson, E.E., ‘‘Safety Limit Warning
Levels for the Avoidance of Excessive
Sound Amplification to Protect Against
Further Hearing Loss.’’ International
Journal of Audiology, 56(11):829–836,
2017.
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11. Tedeschi, T., C. Jones, and E. Stewart.
‘‘Real World Evidence on Gain and
Output Settings for Individuals with
Mild-to-Moderate Hearing Loss.’’
Hearing Review, 27(7):9–11, 2020.
12. Ahmad, I., W.C. Lee, and J.D. Binnington.
‘‘External Auditory Canal Measurements:
Localization of the Isthmus.’’
Otorhinolaryngologia Nova, 10:183–186,
2000.
13. Grewe, J., C. Thiele, et al. ‘‘New HRCTBased Measurement of the Human Outer
Ear Canal as a Basis for Acoustical
Methods.’’ American Journal of
Audiology, 22:65–73, 2013.
14. NASEM, ‘‘Over-The-Counter Hearing
Devices Discussion: Safety and Quality
Requirements and Considerations
Session.’’ MP3, 1:15:39 (English).
National Academies’ Hearing Health
Care Report: June 2017 Dissemination
Meeting; Washington, DC, 2017.
*15. FDA, ‘‘Streamlining Good
Manufacturing Practices (GMPs) for
Hearing Aids,’’ public workshop. Silver
Spring, MD; April 21, 2016. Available at:
https://wayback.archive-it.org/7993/
20171114234227/https://www.fda.gov/
MedicalDevices/NewsEvents/
WorkshopsConferences/ucm480336.htm.
*16. FDA, ‘‘Regulatory Impact Analysis;
Regulatory Flexbility Analysis;
Unfunded Mandates Reform Act
Analysis.’’ 2022. Available at: https://
www.fda.gov/AboutFDA/
ReportsManualsForms/Reports/
EconomicAnalyses/default.htm.
List of Subjects
21 CFR Part 800
Administrative practice and
procedure, Medical devices,
Ophthalmic goods and services,
Packaging and containers, Reporting
and recordkeeping requirements.
21 CFR Part 801
Labeling, Medical devices, Reporting
and recordkeeping requirements.
21 CFR Part 808
Intergovernmental relations, Medical
devices.
21 CFR Part 874
Medical devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act, and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 800,
801, 808, and 874 are amended as
follows:
PART 800—GENERAL
1. The authority citation for part 800
is revised to read as follows:
■
Authority: 21 U.S.C. 321, 334, 351, 352,
355, 360e, 360i, 360j, 360k, 361, 362, 371.
Section 800.30 also issued under Sec. 709,
Pub. L. 115–52, 131 Stat. 1065–67.
2. Add § 800.30 to subpart B to read
as follows:
■
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§ 800.30 Over-the-counter hearing aid
controls.
(a) Scope. This section specifies the
requirements for over-the-counter (OTC)
air-conduction hearing aids. Airconduction hearing aids that satisfy the
requirements in paragraphs (c) through
(f) of this section are considered
‘‘available’’ over the counter as section
520(q)(1)(A)(v) of the Federal Food,
Drug, and Cosmetic Act uses the term.
Air-conduction hearing aids that do not
meet the definition in section 520(q) of
the Federal Food, Drug, and Cosmetic
Act or do not satisfy the following
requirements are prescription hearing
aids. Unless otherwise specified, the
requirements in this section are in
addition to other applicable
requirements, including but not limited
to special controls found in the
applicable classification regulation in
part 874 of this chapter.
(b) Definitions for the purposes of this
section. This section uses the following
definitions:
Air-conduction hearing aid. An airconduction hearing aid is a hearing aid
that conducts sound to the ear through
the air.
Hearing aid. A hearing aid is any
wearable device designed for, offered for
the purpose of, or represented as aiding
persons with or compensating for,
impaired hearing.
Licensed person. A licensed person is
a person as defined in section 201(e) of
the Federal Food, Drug, and Cosmetic
Act that holds a license or degree for the
diagnosis, assessment, or treatment of
hearing loss; or that holds a license to
sell or distribute hearing aids. A person
that must meet generally applicable
licensing or operating requirements
such as annual health and safety
inspections, provided the generally
applicable licensing or operating
requirement is consistent with this
section and other applicable
requirements under the Federal Food,
Drug, and Cosmetic Act, is not a
‘‘licensed person’’ solely for that reason.
A person that represents as a marketer,
seller, dispenser, distributor, or
customer support representative (or an
equivalent description) is not a
‘‘licensed person’’ solely by making
such representations.
Over-the-counter hearing aid. An
over-the-counter (OTC) hearing aid is an
air-conduction hearing aid that does not
require implantation or other surgical
intervention, and is intended for use by
a person age 18 or older to compensate
for perceived mild to moderate hearing
impairment. The device, through tools,
tests, or software, allows the user to
control the hearing aid and customize it
to the user’s hearing needs. The device
may use wireless technology or may
include tests for self-assessment of
hearing loss. The device is available
over-the-counter, without the
supervision, prescription, or other
order, involvement, or intervention of a
licensed person, to consumers through
in-person transactions, by mail, or
online, provided that the device satisfies
the requirements in this section.
Prescription hearing aid. A
prescription hearing aid is a hearing aid
that is not an OTC hearing aid as
defined in this section or a hearing aid
that does not satisfy the requirements in
this section.
Rebuilt hearing aid. An OTC hearing
aid is ‘‘rebuilt’’ if the manufacturer has
inspected and tested the device, made
50749
any necessary modifications to ensure it
meets applicable regulatory
requirements, including the
requirements in this section to be
available OTC, and adequately
reprocessed the device for the next user.
Sale. Sale includes a lease, rental, or
any other purchase or exchange for
value.
Tools, tests, or software. Tools, tests,
or software are components of the
device that, individually or in
combination, allow a lay user to control
the device and customize it sufficiently,
such as the device’s output, to meet the
user’s hearing needs.
Used hearing aid. A hearing aid is
‘‘used’’ if a user has worn it for any
period of time. However, a hearing aid
shall not be ‘‘used’’ merely because a
prospective user wore it as part of a
bona fide hearing aid evaluation to
determine whether to select that
particular hearing aid for that
prospective user. A hearing aid
evaluation is ‘‘bona fide’’ if it was
conducted in the presence of the
dispenser or a hearing health
professional selected by the dispenser to
assist the prospective user in making a
determination.
(c) Labeling. An OTC hearing aid shall
bear all of the following in the labeling:
(1) Outside package labeling. The
outside package of an OTC hearing aid
shall bear all of the following:
(i) Warnings and other important
information. All of the following shall
appear on the outside package:
(A) (A) Warning against use in people
younger than 18.
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(B) Symptoms suggesting perceived
mild to moderate hearing loss.
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(C) Advice of availability of
professional services.
(D) ‘‘Red flag’’ conditions.
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(F) Notice of manufacturer’s return
policy.
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(ii) Statement of build condition. If
the OTC hearing aid is used or rebuilt,
the outside package shall declare that
fact. A sticker under and visible through
the outer wrapper will suffice to declare
such fact.
(iii) Statement of OTC availability.
The principal display panel shall bear
the marks ‘‘OTC’’ and ‘‘hearing aid’’
with the same prominence required
under § 801.61(c) of this chapter for the
device’s statement of identity. The
device’s common name on the principal
display panel may satisfy all or part of
this requirement to the extent the
common name includes the marks.
(iv) Indication of battery information.
The outside package shall indicate the
type and number of batteries and
whether batteries are included in the
package.
(v) Indication of control platform. The
outside package shall indicate whether
a mobile device or other non-included
control platform is required. The
indication must include the type of
platform and how the platform connects
to the device.
(2) Labeling, inside the package. The
manufacturer or distributor of an OTC
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hearing aid shall include a user
instructional brochure inside the
package and shall make an electronic
version available for download without
site or customer registration and
without requiring purchase of any
product or service. The user
instructional brochure shall include all
of the following:
(i) The following warnings, which
shall appear in the following order and
prior to any content except the cover
page:
(A) Warning against use in people
younger than 18.
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(B) ‘‘Red flag’’ conditions.
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(C) Warning about pain from device
placement.
(ii) Any additional warnings the
manufacturer may include prior to the
cautions and notices to users in
paragraph (c)(2)(iii) of this section.
(iii) The following cautions and
notices for users, which shall appear
prior to any content except the cover
page and the warnings under paragraphs
(c)(2)(i) and (ii) of this section:
(A) Caution about hearing protection.
(B) Caution about excessive sound
output.
ER17AU22.011
ER17AU22.012
(C) Caution about components
lodging in ear.
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(E) Note about user expectations.
(iv) An illustration(s) of the OTC
hearing aid that indicates operating
controls, user adjustments, and the
battery compartment.
(v) Information on the function of all
controls intended for user adjustment.
(vi) A description of any accessory
that accompanies the OTC hearing aid,
including but not limited to wax guards
and accessories for use with a computer,
television, or telephone.
(vii) Specific instructions for all of the
following:
(A) Instructions for sizing or inserting
the eartip of the OTC hearing aid to
prevent insertion past the depth limit
and damage to the tympanic membrane.
(B) The tools, tests, or software that
allow the user to control the OTC
hearing aid, including self-selection and
self-checking the performance of the
OTC hearing aid, and customize it to the
user’s hearing needs, including
information about properly fitting
eartips.
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(C) Use of the OTC hearing aid with
any accompanying accessories.
(D) Maintenance and care of the OTC
hearing aid, including how a lay user
can clean, disinfect, and replace parts or
how to seek replacements, as well as
how to store the hearing aid when it
will not be used for an extended period
of time.
(E) If the battery is replaceable or
rechargeable, how to replace or recharge
the battery, including a generic
designation of replacement batteries.
(F) Expected battery life.
(G) Any other information necessary
for adequate directions for use as
defined in § 801.5 of this chapter.
(viii) Identification of any known
physiological side effects associated
with the use of the OTC hearing aid that
may warrant consultation with a
physician, referring to an ear-nosethroat doctor when preferable, including
if applicable, skin irritation and
accelerated accumulation of cerumen
(ear wax).
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(ix) The technical specifications
required by paragraph (c)(4) of this
section.
(x) A description of commonly
occurring, avoidable events that could
adversely affect or damage the OTC
hearing aid, including but not limited
to, as applicable, ear wax buildup,
drops, immersion in water, or exposure
to excessive heat.
(xi) If the hearing aid incorporates
wireless technology in its programming
or use, appropriate warnings,
instructions, and information relating to
electromagnetic compatibility and
wireless technology and human
exposure to non-ionizing radiation.
(xii) Information on how and where to
obtain repair service or replacements,
including at least one specific address
where the user can go or send the OTC
hearing aid to obtain such repair service
or replacements.
(xiii) If clinical or non-clinical studies
were conducted by or for the
manufacturer to support the
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performance of the OTC hearing aid, a
summary of all such studies.
(3) Labeling on the device. The
labeling on an OTC hearing aid itself
shall bear all of the following clearly
and permanently, except as provided in
paragraph (c)(3)(iii) of this section:
(i) The serial number.
(ii) If the battery is removable, a ‘‘+’’
symbol to indicate the positive terminal
for battery insertion unless the battery’s
physical design prevents inserting the
battery in the reversed position.
(iii) If the OTC hearing aid is used or
rebuilt, the manufacturer shall
physically attach a removable tag to the
hearing aid declaring that fact.
(4) Technical specifications. All of the
following technical specifications shall
appear in the user instructional
brochure that accompanies the device.
You may additionally include it on the
outside package:
(i) The maximum output limit value
(Output Sound Pressure Level 90
(OSPL90)).
(ii) The full-on gain value, which is
the gain with a 50 decibel (dB) Sound
Pressure Level (SPL) pure-tone input
and volume set to full on.
(iii) The total harmonic distortion
value.
(iv) The self-generated noise value.
(v) The latency value.
(vi) The upper and lower cutoff
frequencies for bandwidth.
(5) Software device labeling. OTC
hearing aid software that is not
distributed with the hearing aid or
amplification platform shall meet all of
the following labeling requirements.
With respect to the information required
under paragraphs (c)(1) through (4) of
this section, the information must be
provided in the software device
labeling, as specified in paragraphs
(c)(5)(i) through (v) of this section,
rather than the locations (e.g., outside
package labeling) specified in
paragraphs (c)(1) through (4):
(i) Prior to first use of the software or
obtaining payment information for the
software, whichever occurs first, the
labeling must clearly and prominently
present all of the following to the
prospective user. For each, the labeling
must remain visible until the user
dismisses it or proceeds to the next step:
(A) Compatibility and minimum
operating requirements for the software
device.
(B) Disclosures of any fees or
payments after first use or initial
payment, including but not limited to
any fees or payments relating to
subscriptions, add-on features, or
continued access to features or services.
The disclosures must name and briefly
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describe what each fee or payment
covers.
(C) The information required under
paragraphs (c)(1)(i), (iii), and (v) of this
section.
(ii) Prior to first use of the software,
the labeling must clearly and
prominently present all of the following
to the prospective user:
(A) The information required under
paragraph (c)(2)(i)(A) of this section,
and it must remain visible until the user
acknowledges it.
(B) The information required under
paragraphs (c)(2)(i)(B) and (C), (c)(2)(ii),
(iii), and (v), (c)(2)(vii)(B) and (G), and
(c)(2)(viii) and (ix) of this section, and
the information must remain visible
until the user dismisses it or proceeds
to the next step.
(C) All other information required
under paragraph (c)(2) of this section, to
the extent applicable, and the
information must remain visible until
the user dismisses it or proceeds to the
next step.
(iii) The software device labeling must
include the information required under
paragraphs (c)(3)(i) and (c)(4) of this
section.
(iv) All of the software device labeling
must be accessible for review after
acknowledgment, dismissal, or
proceeding to the next step.
(v) If there are changes to any of the
labeling required under paragraph (c)(5)
of this section, the labeling with the
changed information must be presented
to the user until the user dismisses it.
(d) Output limits. The output limit for
an OTC hearing aid shall be the device
maximum acoustic output sound
pressure level (SPL) with an acoustic
coupler as described in paragraph (e)(6)
of this section when the device input is
a 90 dB SPL pure-tone, and the gain/
volume control is full on. An OTC
hearing aid shall not exceed the
following limits at any of the
frequencies at which the device is
intended to operate:
(1) General output limit. An OTC
hearing aid shall not exceed an output
limit of 111 dB SPL at any frequency
except as provided in paragraph (d)(2)
of this section.
(2) Output limit for a device with
activated input-controlled compression.
An OTC hearing aid that has inputcontrolled compression activated shall
not exceed an output limit of 117 dB
SPL at any frequency.
(e) Electroacoustic performance
limits. An OTC hearing aid shall
perform within all of the following
electroacoustic limits. Measure each
electroacoustic performance
characteristic using an acoustic coupler
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as described in paragraph (e)(6) of this
section, where applicable:
(1) Output distortion control limits.
Test the output distortion of the OTC
hearing aid as follows to ensure that it
does not exceed the limit specified in
paragraphs (e)(1)(i) through (iii) of this
section.
(i) The total harmonic distortion plus
noise shall not exceed 5 percent for
output levels within one of the
following sets of levels, depending on
the test method:
(A) Using sine wave-based testing,
measure at 70 dB SPL and 100 dB SPL;
or
(B) Using a 500-hertz (Hz) one-thirdoctave pulsed-noise signal, measure at
67 dB SPL and 97 dB SPL.
(ii) You must measure the total
harmonic distortion using a 500-Hz
input tone with an analyzer that has a
bandwidth at least as wide as the
frequency limits of the OTC hearing aid.
(iii) You must measure the output
distortion at the OTC hearing aid’s
maximum volume and the input sound
level to the OTC hearing aid adjusted to
produce the required outputs.
(2) Self-generated noise level limits.
Self-generated noise shall not exceed 32
dBA. You must disable any methods
that artificially lower the apparent noise
floor for the measurement. Such
methods would include but are not
limited to auto-muting and downward
expansion.
(3) Latency. Latency shall not exceed
15 ms. You must measure the latency
with a method that is accurate and
repeatable to within 1.5 ms.
(4) Frequency response bandwidth.
The lower cutoff frequency shall extend
to 250 Hz or below, and the upper cutoff
frequency shall extend to 5 kHz or
greater. You must measure the
frequency response bandwidth as
specified in the Method for clause 4.1 in
ANSI/CTA–2051:2017.
(5) Frequency response smoothness.
No single peak in the one-third-octave
frequency response shall exceed 12 dB
relative to the average levels of the onethird-octave bands, two-thirds octave
above and below the peak. You must
measure the frequency response
smoothness using values for a diffuse
field and the corrected one-third-octave
frequency insertion response as
specified in the Method for clause 4.1 in
ANSI/CTA–2051:2017.
(6) Acoustic coupler choice. Where
applicable, use one of the following
acoustic couplers to measure
electroacoustic performance:
(i) When compatible with the device
design, a 2-cubic centimeter (cm3)
acoustic coupler; or
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(ii) When a 2-cm3 acoustic coupler is
not compatible with the device design,
an acoustic coupler that is a
scientifically valid and technically
equivalent alternative. You must
document the rationale for using an
alternative acoustic coupler.
(f) Design requirements. An OTC
hearing aid must conform to all of the
following design requirements:
(1) Insertion depth. The design of an
OTC hearing aid shall limit the insertion
of the most medial component so that,
when inserted, the component is
reasonably expected to remain at least
10 millimeters (mm) from the tympanic
membrane.
(2) Use of atraumatic materials. The
material for the eartip of an OTC hearing
aid shall be atraumatic.
(3) Proper physical fit. The design of
an OTC hearing aid shall enable
consumers to readily achieve a safe,
customized, acoustically favorable, and
comfortable physical fit in the ear canal
and/or external ear.
(4) Tools, tests, or software. The OTC
hearing aid shall, through tools, tests, or
software, permit a lay user to control the
device and customize it to the user’s
hearing needs.
(5) User-adjustable volume control.
The OTC hearing aid shall have a useradjustable volume control.
(6) Adequate reprocessing. If the OTC
hearing aid is used or rebuilt, it must be
adequately reprocessed for the next user
prior to sale.
(g) Conditions for sale of an OTC
hearing aid. The sale of an OTC hearing
aid is subject to all of the following
conditions:
(1) Age minimum. Sale to or for a
person younger than 18 years of age is
prohibited.
(2) Statement of OTC availability. Sale
of an OTC hearing aid is prohibited
unless its labeling bears the statement of
OTC availability required under
paragraph (c)(1)(iii) of this section.
(h) Effect on State law. Any State or
local government requirement for an
OTC hearing aid is preempted to the
following extent:
(1) Preemption. No State or local
government shall establish or continue
in effect any law, regulation, order, or
other requirement specifically related to
hearing products that would restrict or
interfere with the servicing, marketing,
sale, dispensing, use, customer support,
or distribution of OTC hearing aids
through in-person transactions, by mail,
or online, that is different from, in
addition to, or otherwise not identical
to, the regulations promulgated under
section 709(b) of the FDA
Reauthorization Act of 2017, including
any State or local requirement for the
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supervision, prescription, or other
order, involvement, or intervention of a
licensed person for consumers to access
OTC hearing aids.
(2) Professional requirements—(i)
General rule. The servicing, marketing,
sale, dispensing, customer support, or
distribution of OTC hearing aids, or an
equivalent activity, whether through inperson transactions, by mail, or online,
shall not cause, require, or otherwise
obligate a person providing such
services to obtain specialized licensing,
certification, or any other State or local
sanction unless such requirement is
generally applicable to the sale of any
product or to all places of business
regardless of whether they sell OTC
hearing aids. However, although a State
or local government may not require the
order, involvement, or intervention of a
licensed person for consumers to access
OTC hearing aids, a licensed person
may service, market, sell, dispense,
provide customer support for, or
distribute OTC hearing aids.
(ii) Sale of OTC hearing aids is not an
exemption. The servicing, marketing,
sale, dispensing, customer support, or
distribution of OTC hearing aids does
not exempt a person from any State or
local government’s professional or
establishment requirements that are
consistent with this section.
(iii) Representations may create
professional obligations. A person shall
not incur specialized obligations by
representing as a servicer, marketer,
seller, dispenser, customer support
representative, or distributor (or an
equivalent description) of OTC hearing
aids. However, a person representing as
any other defined professional or
establishment, or as a State licensed
dispenser, is subject to applicable State
and local requirements even if the
person undertakes commercial or
professional activities only in relation to
OTC hearing aids.
(3) Private remedies. This section
does not modify or otherwise affect the
ability of any person to exercise a
private right of action under any State
or Federal product liability, tort,
warranty, contract, or consumer
protection law.
(i) Incorporation by reference. ANSI/
CTA–2051, ‘‘Personal Sound
Amplification Performance Criteria,’’
dated January 2017 (ANSI/CTA–
2051:2017), is incorporated by reference
into this section with the approval of
the Director of the Office of the Federal
Register under 5 U.S.C. 552(a) and 1
CFR part 51. This material is available
for inspection at the Food and Drug
Administration and at the National
Archives and Records Administration
(NARA). Contact the Dockets
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Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240–
402–7500. For information on the
availability of this material at NARA,
email: fr.inspection@nara.gov, or go to:
www.archives.gov/federal-register/cfr/
ibr-locations.html. The material may be
obtained from Consumer Technology
Association (CTA), Technology &
Standards Department, 1919 S Eads
Street, Arlington, VA 22202; phone:
703–907–7600; fax: (703) 907–7693;
email: standards@ce.org, website:
www.cta.tech.
PART 801—LABELING
3. The authority citation for part 801
is revised to read as follows:
■
Authority: 21 U.S.C. 321, 331–334, 351,
352, 360d, 360i, 360j, 371, 374.
§ 801.420
■
[Removed]
4. Remove § 801.420.
§ 801.421
[Removed]
5. Remove § 801.421.
■ 6. Add § 801.422 to subpart H to read
as follows:
■
§ 801.422
labeling.
Prescription hearing aid
(a) Scope. This section specifies the
labeling requirements for prescription
hearing aids. Any hearing aid that does
not satisfy the requirements of § 800.30
of this chapter shall be a prescription
device. Unless otherwise specified, the
requirements in this section are in
addition to other applicable
requirements, including but not limited
to special controls found in the
applicable classification regulation in
part 874 of this chapter. This section
does not apply to group auditory
trainers.
(b) Definitions for the purposes of this
section. This section uses the following
definitions:
Dispenser. A dispenser is any person,
as defined in section 201(e) of the
Federal Food, Drug, and Cosmetic Act,
engaged in the sale of hearing aids to
any member of the consuming public or
any employee, agent, salesperson, and/
or representative of such a person.
Hearing aid. A hearing aid is any
wearable device designed for, offered for
the purpose of, or represented as aiding
persons with or compensating for,
impaired hearing.
Prescription hearing aid. A
prescription hearing aid is a hearing aid
that is not an over-the-counter (OTC)
hearing aid as defined in § 800.30 of this
chapter or a hearing aid that does not
satisfy the requirements in § 800.30 of
this chapter.
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Rebuilt hearing aid. A prescription
hearing aid is ‘‘rebuilt’’ if the
manufacturer has inspected and tested
the device, made any necessary
modifications to ensure it meets
applicable regulatory requirements,
including the requirements in this
section, and adequately reprocessed the
device for the next user.
Sale. Sale includes a lease, rental, or
any other purchase or exchange for
value.
Used hearing aid. A hearing aid is
‘‘used’’ if a user has worn it for any
period of time. However, a hearing aid
shall not be ‘‘used’’ merely because a
prospective user wore it as part of a
bona fide hearing aid evaluation to
determine whether to select that
particular hearing aid for that
prospective user. A hearing aid
evaluation is ‘‘bona fide’’ if it was
conducted in the presence of the
dispenser or a hearing health
professional selected by the dispenser to
assist the prospective user in making a
determination.
(c) Labeling. A prescription hearing
aid shall bear all of the following
labeling:
(1) Outside package labeling. The
outside package of a prescription
hearing aid shall bear all of the
following:
(i) Warnings and other important
information. All of the following shall
appear on the outside package:
(A) Warning against use in people
younger than 18 without prior medical
evaluation.
BILLING CODE 4164–01–P
(B) ‘‘Red flag’’ conditions.
ER17AU22.016
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(C) Note about device trial options.
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(ii) Statement of build condition. If
the prescription hearing aid is used or
rebuilt, the outside package shall
declare that fact. A sticker under and
visible through the outer wrapper will
suffice to declare such fact.
(iii) Indication of battery information.
The outside package shall indicate the
type and number of batteries and
whether batteries are included in the
package.
(iv) Indication of control platform.
That outside package shall indicate
whether a mobile device or other nonincluded control platform is required.
The indication must include the type of
platform and how the platform connects
to the device.
(2) Labeling, inside the package. The
manufacturer or distributor of a
prescription hearing aid shall include a
user instructional brochure inside the
package and shall make an electronic
version available for download without
site or customer registration and
50757
without requiring purchase of any
product or service. The user
instructional brochure shall include all
of the following:
(i) The following warnings, which
shall appear in the following order and
prior to any content except the cover
page:
(A) Warning against use in people
younger than 18 without prior medical
evaluation.
ER17AU22.018
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(B) ‘‘Red flag’’ conditions, addressed
to dispensers.
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(C) Warning to dispensers about very
high-output devices.
prior to any content, except the cover
page and the warnings under paragraph
(c)(2)(i) of this section:
(A) Caution about hearing protection.
ER17AU22.021
notices to users in paragraph (c)(2)(ii) of
this section.
(ii) The following cautions and
notices for users, which shall appear
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ER17AU22.020
(B) Caution about excessive sound
output.
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(D) Additional warnings. Any
additional warnings the manufacturer
may include prior to the cautions and
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(C) Caution about components
lodging in ear.
(D) Note about user expectations.
ER17AU22.024
ER17AU22.023
(F) Note about hearing loss in people
younger than 18 and fitting devices.
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ER17AU22.025
(E) Note about reporting adverse
events to FDA.
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BILLING CODE 4164–01–C
(iii) An illustration(s) of the
prescription hearing aid that indicates
operating controls, user adjustments,
and the battery compartment.
(iv) Information on the function of all
controls intended for user adjustment.
(v) A description of any accessory that
accompanies the prescription hearing
aid, including but not limited to wax
guards, and accessories for use with a
computer, television, or telephone.
(vi) Specific instructions for all of the
following:
(A) Use of the prescription hearing aid
with any accompanying accessories.
(B) Maintenance and care of the
prescription hearing aid, including how
a user can clean, disinfect, and replace
parts or how to seek replacements, as
well as how to store the hearing aid
when it will not be used for an extended
period of time.
(C) If the battery is replaceable or
rechargeable, how to replace or recharge
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the battery, including a generic
designation of replacement batteries.
(D) Expected battery life.
(vii) Identification of any known
physiological side effects associated
with the use of the prescription hearing
aid that may warrant consultation with
a physician, referring to an ear-nosethroat doctor when preferable, including
if applicable, skin irritation and
accelerated accumulation of cerumen
(ear wax).
(viii) The technical specifications
required by paragraph (c)(4) of this
section unless such specifications
appear in separate labeling
accompanying the prescription hearing
aid.
(ix) A description of commonly
occurring, avoidable events that could
adversely affect or damage the
prescription hearing aid, including but
not limited to, as applicable, ear wax
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buildup, drops, immersion in water, or
exposure to excessive heat.
(x) If the hearing aid incorporates
wireless technology in its programming
or use, appropriate warnings,
instructions, and information relating to
electromagnetic compatibility and
wireless technology and human
exposure to non-ionizing radiation.
(xi) Information on how and where to
obtain repair service or replacements,
including at least one specific address
where the user can go or send the
prescription hearing aid to obtain such
repair service or replacements.
(xii) If clinical or non-clinical studies
were conducted by or for the
manufacturer to support the
performance of the prescription hearing
aid, a summary of all such studies.
(3) Labeling on the device. The
labeling on a prescription hearing aid
itself shall bear all of the following
clearly and permanently, except as
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provided in paragraph (c)(3)(iii) of this
section:
(i) The serial number.
(ii) If the battery is removable, a ‘‘+’’
symbol to indicate the positive terminal
for battery insertion unless the battery’s
physical design prevents inserting the
battery in the reversed position.
(iii) If the prescription hearing aid is
used or rebuilt, the manufacturer shall
physically attach a removable tag to the
hearing aid declaring that fact.
(4) Technical specifications. You must
determine the technical specification
values for the prescription hearing aid
labeling in accordance with the test
procedures of ANSI/ASA S3.22–2014
(R2020), except as provided in
paragraph (c)(4)(ix) of this section for
latency. Technical specifications and
their associated values that are useful in
selecting, fitting, and checking the
performance of the prescription hearing
aid shall appear in the user instructional
brochure or in separate labeling that
accompanies the device, including all of
the following:
(i) Saturation output curve (Saturation
Sound Pressure Level (SSPL) 90 curve).
(ii) Frequency response curve.
(iii) Average saturation output (High
Frequency (HF)-Average SSPL 90).
(iv) Average full-on gain (HF-Average
full-on gain).
(v) Reference test gain.
(vi) Frequency range.
(vii) Total harmonic distortion.
(viii) Equivalent input noise.
(ix) Latency, measured using a
method that is accurate and repeatable
to within 1.5 ms.
(x) Battery current drain.
(xi) Induction coil sensitivity
(telephone coil aids only).
(xii) Input-output curve (only for
hearing aids with automatic gain
control).
(xiii) Attack and release times (only
for hearing aids with automatic gain
control).
(5) Software device labeling.
Prescription hearing aid software that is
not distributed with the hearing aid or
amplification platform shall meet all of
the following labeling requirements.
With respect to the information required
under paragraphs (c)(1) through (4) of
this section, the information must be
provided in the software device
labeling, as specified in paragraphs
(c)(5)(i) through (v) of this section,
rather than the locations (e.g., outside
package labeling) specified in
paragraphs (c)(1) through (4).
(i) Prior to first use of the software or
obtaining payment information for the
software, whichever occurs first, the
labeling must clearly and prominently
present all of the following to the
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prospective user. For each, the labeling
must remain visible until the user
dismisses it or proceeds to the next step:
(A) Compatibility and minimum
operating requirements for the software
device.
(B) Disclosures of any fees or
payments after first use or initial
payment, including but not limited to
any fees or payments relating to
subscriptions, add-on features, or
continued access to features or services.
The disclosures must name and briefly
describe what each fee or payment
covers.
(C) The information required under
paragraphs (c)(1)(i) and (iv) of this
section.
(ii) Prior to first use of the software,
the labeling must clearly and
prominently present all of the following
to the prospective user:
(A) The information required under
paragraph (c)(2)(i)(A) of this section,
and it must remain visible until the user
acknowledges it.
(B) The information required under
paragraphs (c)(2)(i)(B) through (D) and
(c)(2)(ii), (iv), (vii), and (viii) of this
section, and the information must
remain visible until the user dismisses
it or proceeds to the next step.
(C) All other information required
under paragraph (c)(2) of this section, to
the extent applicable, and the
information must remain visible until
the user dismisses it or proceeds to the
next step.
(iii) The software device labeling must
include the information required under
paragraphs (c)(3)(i) and (c)(4) of this
section.
(iv) All of the software device labeling
must be accessible for review after
acknowledgment, dismissal, or
proceeding to the next step.
(v) If there are changes to any of the
labeling required under paragraph (c)(5)
of this section, the labeling with the
changed information must be presented
to the user until the user dismisses it.
(6) Misbranding. A prescription
hearing aid that is not labeled as
required under this section and
§ 801.109 is misbranded under sections
201(n), 502(a), and/or 502(f) of the
Federal Food, Drug, and Cosmetic Act.
(d) Incorporation by reference. ANSI/
ASA S3.22–2014 (R2020), ‘‘AMERICAN
NATIONAL STANDARD Specification
of Hearing Aid Characteristics,’’ dated
June 5, 2020, is incorporated by
reference into this section with the
approval of the Director of the Office of
the Federal Register under 5 U.S.C.
552(a) and 1 CFR part 51. This material
is available for inspection at the Food
and Drug Administration and at the
National Archives and Records
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50761
Administration (NARA). Contact the
Dockets Management Staff, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852,
240–402–7500. For information on the
availability of this material at NARA,
email: fr.inspection@nara.gov, or go to:
www.archives.gov/federal-register/cfr/
ibr-locations.html. The material may be
obtained from the Acoustical Society of
America (ASA), 1305 Walt Whitman
Road, Suite 300, Melville, NY 11747;
phone: (631) 390–0215; fax: (631) 923–
2875; email: asastds@
acousticalsociety.org.
PART 808—EXEMPTIONS FROM
FEDERAL PREEMPTION OF STATE
AND LOCAL MEDICAL DEVICE
REQUIREMENTS
7. The authority citation for part 808
is revised to read as follows:
■
Authority: 21 U.S.C. 360j, 360k, 371.
Section 808.1 also issued under Sec. 709,
Public Law 115–52, 131 Stat. 1065–67.
8. In part 808, remove the words ‘‘the
act’’ and add in their place ‘‘the Federal
Food, Drug, and Cosmetic Act’’.
■ 9. In § 808.1, add headings to
paragraphs (a) through (f) and add
paragraph (g) to read as follows:
■
§ 808.1
Scope.
(a) Introduction. * * *
(b) General rule for State and local
requirements respecting devices. * * *
(c) Exempting from preemption
certain State or local requirements
respecting devices. * * *
(d) Meaning of ‘‘requirements
applicable to a device.’’ * * *
(e) Determination of equivalence or
difference of requirements applicable to
a device. * * *
(f) Applicability of Federal
requirements respecting devices. * * *
(g) Exemptions not applicable to
certain State or local government
requirements specifically related to
hearing products. An exemption under
this part shall not apply to any State or
local government law, regulation, order,
or other requirement specifically related
to hearing products, including any
requirement for the supervision,
prescription, or other order,
involvement, or intervention of a
licensed person for consumers to access
over-the-counter hearing aids, that:
(1) Would restrict or interfere with the
servicing, marketing, sale, dispensing,
use, customer support, or distribution of
over-the-counter hearing aids, as
defined under section 520(q) of the
Federal Food, Drug, and Cosmetic Act,
through in-person transactions, by mail,
or online; and
(2) Is different from, in addition to, or
otherwise not identical to, the
E:\FR\FM\17AUR2.SGM
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50762
Federal Register / Vol. 87, No. 158 / Wednesday, August 17, 2022 / Rules and Regulations
regulations issued under section 709(b)
of the FDA Reauthorization Act of 2017.
■ 10. Revise § 808.3 to read as follows:
§ 808.3
Definitions.
Compelling local conditions includes
any factors, considerations, or
circumstances prevailing in, or
characteristic of, the geographic area or
population of the State or political
subdivision that justify exemption from
preemption.
More stringent refers to a requirement
of greater restrictiveness or one that is
expected to afford to those who may be
exposed to a risk of injury from a device
a higher degree of protection than is
afforded by a requirement applicable to
the device under the Federal Food,
Drug, and Cosmetic Act.
Political subdivision or locality means
any lawfully established local
governmental unit within a State which
unit has the authority to establish or
continue in effect any requirement
having the force and effect of law with
respect to a device intended for human
use.
State means any State or Territory of
the United States, including but not
limited to, the District of Columbia and
the Commonwealth of Puerto Rico.
Substantially identical to refers to the
fact that a State or local requirement
does not significantly differ in effect
from a Federal requirement.
§ 808.53
■
■
[Removed and Reserved]
11. Remove and reserve § 808.53.
12. Revise § 808.55 to read as follows:
§ 808.55
California.
JSPEARS on DSK121TN23PROD with RULES2
The following California medical
device requirements are preempted
under section 521(a) of the Federal
Food, Drug, and Cosmetic Act, and FDA
has denied them exemption from
preemption:
(a) Medical devices; general
provisions. Sherman Food, Drug, and
Cosmetic Law, Division 21 of the
California Health and Safety Code,
sections 26207, 26607, 26614, 26615,
26618, 26631, 26640, and 26441, to the
extent that they apply to devices; and
(b) Ophthalmic devices; quality
standards. California Business and
Professions Code, section 2541.3 to the
extent that it requires adoption of the
American National Standards Institute
standards Z–80.1 and Z–80.2.
§§ 808.57 through 808.101
Reserved]
[Removed and
13. Remove and reserve §§ 808.57
through 808.101.
■
VerDate Sep<11>2014
17:52 Aug 16, 2022
Jkt 256001
PART 874—EAR, NOSE, AND THROAT
DEVICES
14. The authority citation for part 874
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
15. Revise § 874.3300 to read as
follows:
■
§ 874.3300
Air-conduction hearing aid.
(a) Identification. An air-conduction
hearing aid is a wearable soundamplifying device intended to
compensate for impaired hearing that
conducts sound to the ear through the
air. An air-conduction hearing aid is
subject to the requirements in § 800.30
or § 801.422 of this chapter, as
applicable. The air-conduction hearing
aid generic type excludes the group
hearing aid or group auditory trainer,
master hearing aid, and the tinnitus
masker, regulated under §§ 874.3320,
874.3330, and 874.3400, respectively.
(b) Classification. Class I (general
controls). This device is exempt from
premarket notification procedures in
subpart E of part 807 of this chapter,
subject to the limitations in § 874.9.
■ 16. Add § 874.3302 to read as follows:
§ 874.3302
Bone-conduction hearing aid.
(a) Identification. A bone-conduction
hearing aid is a wearable soundamplifying device intended to
compensate for impaired hearing and
that conducts sound to the inner ear
through the skull. The non-implantable
components of a bone-conduction
hearing aid, such as the external sound
processor, are subject to the
requirements in § 801.422 of this
chapter.
(b) Classification. Class II.
■ 17. In § 874.3305, add a sentence at
the end of paragraph (a) and revise
paragraph (b) to read as follows:
§ 874.3305 Wireless air-conduction
hearing aid.
(a) * * * A wireless air-conduction
hearing aid is subject to the
requirements in § 800.30 or § 801.422 of
this chapter, as applicable.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) Performance data must
demonstrate the electromagnetic
compatibility (EMC), electrical safety,
and thermal safety of the device;
(2) Performance testing must validate
safety of exposure to non-ionizing
radiation; and
PO 00000
Frm 00066
Fmt 4701
Sfmt 9990
(3) Performance data must validate
wireless technology functions.
*
*
*
*
*
18. In § 874.3315, revise paragraph (a)
to read as follows:
■
§ 874.3315 Tympanic membrane contact
hearing aid.
(a) Identification. A tympanic
membrane contact hearing aid is a
prescription wearable device that
compensates for impaired hearing.
Amplified sound is transmitted by
vibrating the tympanic membrane
through a transducer that is in direct
contact with the tympanic membrane. A
tympanic membrane contact hearing aid
is subject to the requirements in
§ 801.422 of this chapter.
*
*
*
*
*
19. In § 874.3325:
a. Add a sentence at the end of
paragraph (a);
■ b. Revise paragraph (b)(5); and
■ c. Remove paragraph (b)(7).
The addition and revision read as
follows:
■
■
§ 874.3325 Self-fitting air-conduction
hearing aid.
(a) * * * A self-fitting air-conduction
hearing aid is subject to the
requirements in § 800.30 or § 801.422 of
this chapter, as applicable.
(b) * * *
(5) If the device incorporates wireless
technology:
(i) Performance testing must validate
safety of exposure to non-ionizing
radiation; and
(ii) Performance data must validate
wireless technology functions.
*
*
*
*
*
20. In § 874.3950, add a sentence at
the end of paragraph (a) to read as
follows:
■
§ 874.3950 Transcutaneous air conduction
hearing aid system.
(a) * * * A transcutaneous air
conduction hearing aid system is subject
to the requirements in § 801.422 of this
chapter.
*
*
*
*
*
Dated: August 5, 2022.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2022–17230 Filed 8–16–22; 8:45 am]
BILLING CODE 4164–01–P
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17AUR2
Agencies
[Federal Register Volume 87, Number 158 (Wednesday, August 17, 2022)]
[Rules and Regulations]
[Pages 50698-50762]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17230]
[[Page 50697]]
Vol. 87
Wednesday,
No. 158
August 17, 2022
Part II
Department of Health and Human Services
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Food and Drug Administration
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21 CFR Parts 800, 801, et al.
Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-
Counter Hearing Aids; Final Rule
Federal Register / Vol. 87 , No. 158 / Wednesday, August 17, 2022 /
Rules and Regulations
[[Page 50698]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 800, 801, 808, and 874
[Docket No. FDA-2021-N-0555]
RIN 0910-AI21
Medical Devices; Ear, Nose, and Throat Devices; Establishing
Over-the-Counter Hearing Aids
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is
establishing a regulatory category for over-the-counter (OTC) hearing
aids and making related amendments to update the regulatory framework
for hearing aids. Specifically, we define OTC hearing aids and
establish applicable requirements; amend existing rules for consistency
with the new OTC category; repeal the conditions for sale applicable to
hearing aids; amend the existing labeling requirements for hearing
aids; and update regulations relating to decisions on applications for
exemption from Federal preemption that will become obsolete as a result
of changes to the hearing aid requirements. In creating a regulatory
category for OTC hearing aids and amending existing rules, we intend to
provide reasonable assurance of safety and effectiveness for these
devices as well as foster access to, and innovation in, hearing aid
technology, thereby protecting and promoting the public health.
DATES:
Effective date: This rule is effective October 17, 2022.
Compliance dates: For hearing aids that have been legally offered
for sale prior to October 17, 2022, including hearing aids that already
have a 510(k) clearance, compliance with the new or revised
requirements must be achieved by April 14, 2023. For hearing aids that
have not been offered for sale prior to October 17, 2022, or have been
offered for sale but are required to submit a new 510(k) due to changes
unrelated to this rule, compliance with the new or revised requirements
applicable to the hearing aid, and obtaining 510(k) clearance if
applicable, must be achieved before marketing the device on or after
October 17, 2022.
Incorporation by reference: The incorporation by reference of
certain material listed in this rule is approved by the Director of the
Federal Register as of October 17, 2022.
ADDRESSES: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number, found in brackets in the heading of this final rule,
into the ``Search'' box and follow the prompts and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
240-402-7500.
FOR FURTHER INFORMATION CONTACT:
With regard to the final rule: Srinivas Nandkumar, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD 20993, 301-796-6480,
[email protected].
With regard to the information collection: Amber Sanford, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
Purpose of the Final Rule
Summary of the Major Provisions of the Final Rule
Legal Authority
Costs and Benefits
II. Table of Abbreviations and Acronyms Commonly Used in this
Document
III. Background
A. Need for the Regulation
B. History of this Rulemaking and Public Participation
C. Summary of Changes Between Proposed and Final Rules
D. Incorporation by Reference
IV. Legal Authority
V. Comments on the Proposed Rule and FDA's Responses
A. Device Classification and Marketing
B. Scope (Sec. 800.30(a))
C. Definitions (Sec. Sec. 800.30(b) and 801.422(b))
D. Labeling (Sec. 800.30(c))
E. Output Limits (Sec. 800.30(d))
F. Other Device Requirements (Sec. 800.30(e) and (f))
G. Conditions for OTC Sale (Sec. 800.30(g))
H. Preemption Provisions (Sec. 800.30(h))
I. Repeal of Restrictions and Modifications for Prescription
Labeling (Sec. Sec. 801.420, 801.421, 801.422)
J. Other Amendments
VI. Effective and Compliance Dates
A. Effective Date
B. Compliance Dates for Hearing Aids Not Legally Offered for
Sale Prior to the Effective Date
C. Compliance Dates for Hearing Aids Legally Offered for Sale
Prior to the Effective Date
VII. Economic Analysis of Impacts
VIII. Analysis of Environment Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination with Indian Tribal Governments
XII. References
I. Executive Summary
A. Purpose of the Final Rule
Hearing loss affects an estimated 30 million people in the United
States and can have a significant impact on communication, social
participation, and overall health and quality of life. Despite the high
prevalence and public health impact of hearing loss, only about one-
fifth of people who could benefit from a hearing aid seek intervention.
Several barriers likely impede the use of hearing aids in hearing-
impaired individuals such as high cost, stigma of being perceived as
old or debilitated, and value (perceived hearing benefit relative to
price). FDA is finalizing rules to address some of these concerns.
Moreover, the FDA Reauthorization Act of 2017 (FDARA) (Pub. L. 115-
52) directs FDA to establish a category of OTC hearing aids through
rulemaking, and FDARA sets forth various requirements for OTC hearing
aids, including for reasonable assurance of safety and effectiveness,
as well as Federal preemption provisions. In addition to protecting and
promoting the public health, these rules establish the OTC category and
implement the requirements of FDARA.
B. Summary of the Major Provisions of the Final Rule
FDA is establishing a regulatory category for OTC hearing aids to
improve access to hearing aid technology for Americans. OTC hearing
aids are intended to address perceived mild to moderate hearing loss in
people aged 18 or older. Along with the OTC category, we are finalizing
multiple related changes to the overall regulatory framework for
hearing aids to harmonize existing rules with the new OTC category. We
have determined that the requirements set forth in this rulemaking will
protect the public health by providing reasonable assurance of safety
and effectiveness for hearing aids, as well as promote the hearing
health of Americans by lowering barriers to access and fostering
innovation in hearing aid technology.
Among other things, FDARA amended the Federal Food, Drug, and
Cosmetic Act (FD&C Act) by defining OTC hearing aids and providing the
authorities to establish the OTC category of hearing aids among
provisions that are, by definition, general controls. We are finalizing
general controls for OTC hearing aids consistent with FDARA.
[[Page 50699]]
We are finalizing lower output limits than we proposed but have not
substantially changed the other electroacoustic performance
requirements for OTC hearing aids. We have simplified the phrasing
throughout the required labeling and have restated the maximum
insertion depth for OTC hearing aids in terms of a fixed measurement.
However, we are not realigning the air-conduction hearing aid
classification regulations as proposed.
This rulemaking also affects other regulations that applied to
hearing aids. FDA had established device restrictions for hearing aids
that included labeling requirements as well as conditions for sale. We
are removing these device restrictions for hearing aids and
establishing a new regulation for prescription hearing aid labeling.
Further, FDA had by regulation granted or denied exemptions from
Federal preemption for State requirements pertaining to hearing aids.
The removal of the device restrictions on hearing aids, as well as
certain provisions of FDARA, impact most of these previous exemption
decisions, for example, by altering their scope. We are removing the
regulations codifying these decisions and establishing other
regulations clarifying some of the effects of statutory preemption
under FDARA.
C. Legal Authority
The FD&C Act establishes a comprehensive system for the regulation
of devices intended for human use. Hearing aids are devices intended
for human use and so are subject to, among other requirements, the
device provisions of the FD&C Act. FDA has authority to establish
regulatory controls needed to provide reasonable assurance of safety
and effectiveness for these devices. As such, FDA is establishing
regulatory controls for OTC hearing aids and amending regulatory
controls for prescription hearing aids. Moreover, the FD&C Act directs
the establishment of an electronic radiation control program, and
hearing aids and personal sound amplification products (PSAPs) are
electronic products, subject to the electronic radiation control
requirements.
Specific to OTC hearing aids, the FD&C Act and FDARA authorize
multiple controls, including authority for FDA to establish
requirements for device labeling, output limits, conditions for sale
and distribution, and other requirements that provide reasonable
assurance of safety and effectiveness of OTC hearing aids. FDARA
specifically directs FDA to establish a category of OTC hearing aids by
regulation that must include the aforementioned requirements.
More generally, the FD&C Act further provides for labeling
requirements as general controls such that devices (and other medical
products) will not be misbranded. The FD&C Act also authorizes FDA to
issue regulations for the efficient enforcement of the FD&C Act. We are
establishing the following regulations pursuant to these authorities
and to fulfill the directive under FDARA.
Additionally, both the FD&C Act and FDARA include preemption
provisions applicable to hearing aids.
D. Costs and Benefits
This rule to establish OTC hearing aids and align other regulations
generates potential cost savings for consumers with perceived mild to
moderate hearing impairment who wish to buy lower cost hearing aids not
bundled with professional services and not requiring professional
advice, fitting, adjustment, or maintenance but who are currently
unable to buy such products online because of State regulations or
because they do not shop online. This rule also generates costs for
hearing aid manufacturers for changing labeling of existing hearing
aids as well as for reading the rule and revising internal standard
operating procedures in response to the rule. We estimate benefits of
between $6 million and $147 million per year based on 5th and 95th
percentile Monte Carlo results with a mean of $63 million per year. We
estimate annualized costs of between $1 million and $2 million per year
based on 5th and 95th percentile Monte Carlo results with a mean of $1
million per year. Combining benefits and costs, we used Monte Carlo
analysis to estimate annualized net benefits of between $5 million and
$145 million per year based on the 5th and 95th Monte Carlo percentile
results with a mean of $62 million per year at both 3 percent and 7
percent discount rates.
II. Table of Abbreviations and Acronyms Commonly Used in This Document
------------------------------------------------------------------------
Abbreviation/acronym What it means
------------------------------------------------------------------------
510(k)....................... A premarket notification for certain
devices.
ANSI......................... American National Standards Institute.
APA.......................... Administrative Procedure Act.
ASA.......................... Acoustical Society of America.
ASHA......................... American Speech-Language-Hearing
Association.
CDRH......................... Center for Devices and Radiological
Health.
CFR.......................... Code of Federal Regulations.
cm\3\........................ Centimeter cubed (cubic centimeter).
CTA.......................... Consumer Technology Association.
dB........................... Decibel.
dBA.......................... A-weighted decibel.
EA........................... Environmental assessment.
ENT.......................... Ear-Nose-Throat.
FDA.......................... Food and Drug Administration.
FD&C Act..................... Federal Food, Drug, and Cosmetic Act.
FDARA........................ FDA Reauthorization Act of 2017.
FONSI........................ Finding of no significant impact.
FR........................... Federal Register.
FRIA......................... Final Regulatory Impact Analysis.
IQA.......................... Information Quality Act.
ISO.......................... International Organization for
Standardization.
ITU.......................... International Telecommunication Union.
mm........................... Millimeter.
ms........................... Millisecond.
[[Page 50700]]
MSW.......................... Municipal solid waste.
NASEM........................ National Academies of Sciences,
Engineering, and Medicine.
NIOSH........................ National Institute for Occupational
Safety and Health.
OMB.......................... Office of Management and Budget.
OSPL90....................... Output sound pressure level with 90-dB
input.
OTC.......................... Over-the-counter.
PRA.......................... Paperwork Reduction Act of 1995.
PSAP......................... Personal sound amplification product.
Pub. L....................... Public Law.
RMS.......................... Root mean square.
SPL.......................... Sound pressure level.
U.S.C........................ United States Code.
WHO.......................... World Health Organization.
------------------------------------------------------------------------
III. Background
FDA is defining and establishing general controls for an OTC
category of hearing aids. We intend these controls to provide for
reasonable assurance of safety and effectiveness for these devices,
thereby protecting the public health. We also intend these controls to
help improve access to and foster innovation in hearing aid technology
for Americans, thereby promoting the public health. We are making
various other revisions, as described in this document, to align
existing regulations with statutory requirements and the new OTC
category.
For brevity, we will use the following terms as shorthand in this
document: ``Over-the-Counter Hearing Aid Controls'' for the general
controls for OTC hearing aids that we are finalizing under Sec. 800.30
(21 CFR 800.30).
``Commercial activity involving OTC hearing aids'' to refer to any
or all of the following activities: servicing, marketing, sale,
dispensing, use, customer support, or distribution of OTC hearing aids
through in-person transactions, by mail, or online.
``Customizable'' or ``customization,'' unless otherwise noted, to
refer to the elements of the statutory definition for OTC hearing aids
described in section 520(q)(1)(A)(iii) and (iv) of the FD&C Act (21
U.S.C. 360j(q)(1)(A)(iii) and (iv)). That is, for the purposes of this
document, a customizable hearing aid is one that, through tools, tests,
or software, allows the user to control the hearing aid and customize
it to the user's hearing needs. To do so, the hearing aid may use
wireless technology or include tests for self-assessment of hearing
loss. (See also the response to Comment 1 explaining customization in
more technical terms.)
``Involvement of a licensed person'' to refer to the supervision,
prescription, or other order, involvement, or intervention of a
licensed person.
``State or local requirement'' to refer to any State or local law,
regulation, order, or other requirement.
A. Need for the Regulation
Hearing loss affects an estimated 30 million people in the United
States and can have a significant impact on communication, social
participation, and overall health and quality of life (Refs. 1 and 2).
Despite the high prevalence and public health impact of hearing loss,
only about one-fifth of people who could benefit from a hearing aid
seek intervention (Ref. 3). The use of hearing aids has been linked to,
among other health benefits, reductions in the incidence or severity of
cognitive decline, depression, and other health problems in older
adults (Refs. 2, 4, and 5). Additionally, benefits of hearing aid use
can include improved social participation and a better quality of life.
Besides health benefits for individuals, more-widespread adoption
of hearing aids could have broader effects. By increasing social
participation, hearing aids could help to improve inclusion of
individuals in family, economic, civic, and religious life. Thus,
reducing barriers to hearing aid access might contribute to such
improvements. This could be particularly true for people of color,
rural Americans, low-income individuals, and others for whom barriers
to hearing aid access may be especially burdensome.
Several barriers likely impede the use of hearing aids in hearing-
impaired individuals such as high cost, stigma of being perceived as
old or debilitated, and value (perceived hearing benefit relative to
price) (Ref. 6). FDA is finalizing rules to address some of these
concerns.
Moreover, section 709 of FDARA directs FDA to establish a category
of OTC hearing aids through rulemaking, and sets forth various
requirements for OTC hearing aids, including for reasonable assurance
of safety and effectiveness, as well as Federal preemption provisions.
In addition to protecting and promoting the public health, these rules
establish the OTC category and implement the requirements of FDARA.
B. History of This Rulemaking and Public Participation
On October 20, 2021, in the Federal Register, FDA proposed multiple
regulatory changes, including proposing requirements for OTC hearing
aids, that would serve to provide reasonable assurance of safety and
effectiveness of hearing aids, address barriers to access to hearing
aids, and effectuate the requirements of section 709 of FDARA (86 FR
58150). Although the October 2021 proposal was the first step in this
rulemaking, the proposal followed other steps FDA had already taken to
initiate an update of the regulatory framework for hearing aids. Please
refer to the aforementioned issue of the Federal Register for further
details on the proposal and other steps taken by FDA.
We received more than 1,000 comments on the proposed rule by the
close of the comment period, which was January 18, 2022. Commenters
included consumers, professionals, professional associations, hearing
aid manufacturers, public health organizations, public advocacy groups,
members of Congress, and State agencies. We describe and respond to the
comments in section V of this document. We have grouped similar
comments together under the same number, and in some cases, we have
separated different issues discussed in the same comment and designated
them as distinct comments for purposes of our responses. The number
assigned to each comment or comment topic is purely for organizational
purposes and does not signify the comment's value or importance or the
order in which we received comments.
[[Page 50701]]
C. Summary of Changes Between Proposed and Final Rules
In response to comments, we have made (and declined) a number of
changes for the final rule. The following summarizes the outcomes that
may be of greatest interest to readers:
Output limits. We are finalizing lower output limits than we
proposed. The general limit will be 111 decibels of sound pressure
level (dB SPL), with 117 dB SPL allowable for devices while input-
controlled compression is activated.
Gain limit. We did not propose, and are not finalizing, a separate
gain limit.
Design requirements. We have revised the allowable insertion depth.
The most medial (innermost) component of an OTC hearing aid must be
reasonably expected to remain at least 10 millimeters (mm) from the
tympanic membrane (eardrum). We are also requiring that all OTC hearing
aids have a user-adjustable volume control.
Labeling. We have improved phrasing throughout the labeling to make
it more understandable for hearing aid users (non-experts).
Conditions for sale. We are not requiring age verification for the
sale of OTC hearing aids. Prescription hearing aid sales will be
subject to the requirements in Sec. 801.109 (21 CFR 801.109),
including that they be sold only to or on the prescription or other
order of a practitioner licensed by law to use or order the use of
(prescribe) the devices (which is as proposed).
Scope and definitions. Perceived mild to moderate hearing
impairment remains the scope of the intended use of OTC hearing aids,
and we are declining to require measurements of hearing loss to
establish prospective users' qualification to purchase OTC hearing
aids.
OTC category and self-fitting air-conduction hearing aid
classification. We are not requiring that OTC hearing aids be self-
fitting devices, and we have provided clarification on the difference
between customization and fitting.
Quality System requirements. OTC hearing aids will be subject to
the requirements under part 820 (21 CFR part 820), which describes a
quality management system appropriate for medical devices.
We explain those decisions and others, as well as provide our
thinking on other topics in the sections that follow.
D. Incorporation by Reference
FDA is incorporating by reference ANSI/CTA-2051, ``Personal Sound
Amplification Performance Criteria,'' dated January 2017, which was
approved by the Office of the Federal Register. You may obtain a copy
from the Consumer Technology Association (CTA), 1919 S. Eads St.,
Arlington, VA 22202; https://www.cta.tech, 703-907-7600. Among other
things, it describes how to measure frequency response and includes
technical data for adaptations for different circumstances and provides
a standardized way to quantify frequency response for OTC hearing aids
and to meet the related electroacoustic performance requirements.
FDA is also incorporating by reference ANSI/ASA S3.22-2014 (R2020),
``Specification of Hearing Aid Characteristics,'' dated June 5, 2020,
which was approved by the Office of the Federal Register. You may
obtain a copy from the Acoustical Society of America (ASA), 1305 Walt
Whitman Road, Suite 300, Melville, NY 11747 Telephone: 1 (631) 390-
0215, Fax: 1 (631) 923-2875, Email: [email protected] or
the American National Standards Institute (ANSI), 1889 L Street NW,
11th Floor, Washington, DC 20036; https://www.ansi.org, 202-293-8020.
ANSI/ASA S3.22-2014 (R2020) describes tolerances and test methods used
for certain measurements of hearing aid performance. The application of
ANSI/ASA S3.22-2014 (R2020) provides professional hearing instrument
specialists with standardized technical information to help them select
the correct hearing aid and ensure optimal fit and performance for
hearing aid users.
IV. Legal Authority
The FD&C Act establishes a comprehensive system for the regulation
of devices, as defined in section 201(h) of the FD&C Act (21 U.S.C.
321(h)), intended for human use. Section 513 of the FD&C Act (21 U.S.C.
360c) defines three classes of devices, reflecting the regulatory
controls needed to provide reasonable assurance of their safety and
effectiveness. The three classes of devices are class I (general
controls), class II (special controls), and class III (premarket
approval) (see 21 U.S.C. 360c). Hearing aids are devices intended for
human use and are subject to the FD&C Act. Currently, air-conduction
hearing aids are generally either class I or class II devices.
The FD&C Act also directs the establishment of an electronic
product radiation control program under section 532(a) to protect the
public health and safety (see 21 U.S.C. 360ii(a)), and requires, among
other things, that manufacturers of electronic products provide
notification of certain defects (see 21 U.S.C. 360ll). Section
531(1)(B) of the FD&C Act defines electronic product radiation as,
among other phenomena, any sonic, infrasonic, or ultrasonic wave
emitted from an electronic product as the result of the operation of an
electronic circuit (see 21 U.S.C. 360hh(1)(B)). In turn, any
manufactured or assembled product which, when in operation, contains or
acts as part of an electronic circuit and emits (or in the absence of
effective shielding or other controls would emit) electronic product
radiation would be an electronic product (see 21 U.S.C. 360hh(2)(A)).
As such, hearing aids and PSAPs emit electronic product radiation and
are electronic products, meaning they are subject to the electronic
product radiation control requirements.
FDARA amended the FD&C Act to apply requirements specific to
certain hearing aids and defined the term ``over-the-counter hearing
aid'' (see 21 U.S.C. 360j(q)). We are issuing these requirements for
OTC hearing aids pursuant to section 709(b) of FDARA, which authorizes
FDA to establish requirements for labeling, output limits, conditions
for sale and distribution of OTC hearing aids, and other requirements
that provide for reasonable assurance of safety and effectiveness of
these devices.
In addition, the FD&C Act provides that a device is misbranded
unless, among other requirements, its labeling bears adequate
directions for use (see section 502(f)(1) of the FD&C Act (21 U.S.C.
352(f)(1)). Consistent with section 502 of the FD&C Act, FDA has issued
regulations that exempt certain kinds of devices from the requirement
for adequate directions for use. Section 502(f)(2) further requires
adequate warnings against use of a device in those pathological
conditions, or by children, where use of the device may be dangerous to
health. The labeling must also bear adequate warnings against unsafe
dosage or methods or duration of administration or application (see
section 502(f)(2) of the FD&C Act). Such warnings must be in such
manner and form as are necessary for the protection of the users (see
section 502(f)(2) of the FD&C Act).
A device is also misbranded if its labeling is false or misleading
in any particular (see section 502(a) of the FD&C Act). Section 201(n)
of the FD&C Act states that in determining whether labeling or
advertising is misleading, there shall be taken into account not only
representations made or suggested but also the extent to which labeling
or advertising fails to reveal material facts.
Other misbranding provisions under the FD&C Act would apply as
well,
[[Page 50702]]
including section 502(c), which deems a device to be misbranded if any
word, statement, or other information required by or under authority of
the FD&C Act to appear on the label or labeling is not prominently
placed thereon with such conspicuousness and in such terms as to render
it likely to be read and understood by the ordinary individual under
customary conditions of purchase and use.
Additionally, section 701(a) of the FD&C Act authorizes FDA to
issue regulations for the efficient enforcement of the FD&C Act (21
U.S.C. 371(a)). The regulations established in this rulemaking are for
the efficient enforcement of the FD&C Act because they will provide
standards for the legal marketing of safe and effective hearing aids.
Violations of any final rules from this rulemaking, once in effect,
would render the hearing aids adulterated and/or misbranded under
sections 501 and/or 502 of the FD&C Act, and subject to enforcement
action, for example, seizure (see section 304 of the FD&C Act (21
U.S.C. 334)), injunction (see section 302 of the FD&C Act (21 U.S.C.
332)), and criminal prosecution (see section 303 of the FD&C Act (21
U.S.C. 333)). Prohibited acts include, among others, introducing an
adulterated or misbranded device into interstate commerce (see section
301 of the FD&C Act (21 U.S.C. 331)). Sections 538 and 539 of the FD&C
Act additionally set forth prohibited acts and provisions for
enforcement for electronic product radiation control (see 21 U.S.C.
360oo and 360pp, respectively).
Under section 521 of the FD&C Act, no State or political
subdivision of a State may establish or continue in effect with respect
to a device intended for human use any requirement that is different
from, or in addition to, any requirement applicable under the FD&C Act
to the device and that relates to the safety or effectiveness of the
device or to any other matter included in a requirement applicable to
the device under the FD&C Act (21 U.S.C. 360k). Section 521 of the FD&C
Act also provides that FDA may grant an exemption from preemption under
certain circumstances. Section 709(b) of FDARA also includes a
preemption provision with respect to requirements for OTC hearing aids.
V. Comments on the Proposed Rule and FDA's Responses
In the proposed rule, FDA welcomed comments on all aspects of the
proposal, and we specifically requested comments on certain topics to
encourage more-targeted feedback. Such topics included:
the clarity of the definitions and ways to improve them;
labeling requirements;
equitable access to hearing aids and information about them;
whether State or local requirements for returns would promote or
restrict or interfere with commercial activities involving OTC
hearing aids;
design requirements to limit insertion depth;
proposals for modification of, or alternatives to, the current
applicable Quality System requirements for OTC hearing aids;
conditions for sale of OTC hearing aids to prevent sale to or
for people younger than 18;
the removal of regulations in 21 CFR part 808 (part 808)
regarding exemptions from Federal preemption for State and local
requirements respecting hearing aids;
possible effects of the rule on small manufacturers;
data concerning the environmental assessment and our proposal
for a finding of no significant impact (FONSI);
topics related to the Paperwork Reduction Act of 1995 (PRA) and
associated estimates for recordkeeping burdens; and
potential impacts on Indian Tribes from this rulemaking.
As appropriate, we summarize such comments that we received, along
with other pertinent comments, and respond to them in the corresponding
subsections that follow. As we indicated in the proposal, we considered
only comments submitted to the docket for this rulemaking that were
timely and pertinent (see 86 FR 58150-58161).
The vast majority of comments that we received supported rulemaking
to encourage wider adoption of safe and effective hearing aids for
people who could benefit from them. FDA agrees that rulemaking can
encourage wider adoption of such devices, and we expect this final rule
to do so. Many commenters conveyed enthusiasm for affordable hearing
aids and/or wider availability without the involvement of a licensed
person, telling us that they expect the difference to make hearing aids
accessible to them--in some cases, for the first time. Some comments
observed that hearing impairment often correlates with lower income,
suggesting that lower prices may be particularly helpful for people who
may want to use hearing aids and that OTC hearing aids could serve an
important role in achieving equitable health outcomes.
Still, many commenters voiced both support and concern for the role
of licensed persons and the value of professional services for hearing
health. In finalizing this rule, FDA is not suggesting that licensed
persons or their professional services are unimportant or not valuable.
Indeed, we recommend consulting licensed persons in several
circumstances, including for the diagnosis of hearing impairment and in
the fitting and continued use of OTC hearing aids when consumers choose
to seek such services. Many commenters asserted that the professional
services are worth the cost. In that vein, one comment suggested that,
like providing alternative distribution channels, increasing the number
of audiologists and other hearing health care providers would also
improve accessibility. This final rule, however, focuses on subjects
within FDA's purview, establishing device requirements that provide
reasonable assurance of safety and effectiveness for OTC hearing aids
without the involvement of a licensed person, as directed by FDARA.
As for specific provisions, the comments generally supported
establishing requirements for labeling, output (volume) limits,
electroacoustic performance requirements, and other design requirements
for OTC hearing aids. However, individual comments varied on the extent
to which they supported specific proposals or proffered alternatives.
Comments that provided a rationale and/or evidence generally lent more
insight for FDA's consideration.
We acknowledge that some comments did not support this rulemaking,
many of them stating that hearing aids are medical devices and should
not be regulated as consumer electronics. We interpret such comments to
mean that OTC hearing aids should not have a relaxed standard for
safety or effectiveness, nor should OTC hearing aids be subject to less
stringent requirements for product quality than other medical devices.
We agree that OTC hearing aids must meet the same standard as other
devices for having reasonable assurance of safety and effectiveness,
consistent with the FD&C Act and section 709 of FDARA, and that OTC
hearing aids be subject to the quality system requirements applicable
to other devices. However, we note that different device types and
categories will raise different issues related to safety and
effectiveness. Thus, while devices must meet the same standard of
having reasonable assurance of safety and effectiveness, different
device types and categories can engender different regulatory
requirements to achieve the same standard. This final rule establishes
requirements specific to hearing aids and although the requirements for
OTC and prescription hearing aids are not the same, these requirements,
along with other applicable requirements under the FD&C Act, provide
for reasonable assurance of safety and effectiveness for
[[Page 50703]]
both categories of hearing aids (we note that in this document when we
describe the requirements in Sec. 800.30 (21 CFR 800.30) or Sec.
801.422 (21 CFR 801.422) as providing reasonable assurance of safety
and effectiveness, we mean in conjunction with other applicable
requirements under the FD&C Act).
A. Device Classification and Marketing
We received several comments about the interplay among device
classification regulations, the OTC Hearing Aid Controls, and premarket
notification requirements. Generally, we agree that clarification on
such issues will help ensure that manufacturers identify and follow the
appropriate regulatory requirements for their devices.
(Comment 1) Multiple comments requested clarification on the
difference between self-fitting hearing aids classified under Sec.
874.3325 (21 CFR 874.3325) and hearing aids that, through tools, tests,
or software allow users to control the hearing aids and customize them
to the users' hearing needs. Many such comments pointed out that the
clarification will help manufacturers determine the applicability of
premarket notification requirements and special controls.
(Response) Under section 520(q)(1)(A) of the FD&C Act, an OTC
hearing aid must be controllable by the user and customizable to the
user's hearing needs. We interpret the requirement for customization to
hearing needs to mean that the device must allow the user to cause
frequency-dependent changes based on the user's preference. This is
because a single profile for gain versus frequency is unlikely to
accommodate the majority of hearing needs for perceived mild to
moderate impairment. For example, a flat gain profile across frequency
is unlikely to meet the hearing needs of users with sloping hearing
loss, the kind of impairment often associated with aging, as well as a
non-flat gain profile across frequency would. However, a flat gain
profile across frequency may be preferable for some people with a
different kind of hearing loss. In short, to have reasonable assurance
of safety and effectiveness of OTC hearing aids, the devices must offer
capabilities for a variety of perceived mild to moderate hearing
impairments, and customization is the method or process that allows the
user to match the device output to individual preference.
We interpret the requirement for user control to mean that the user
can access or select the output characteristics most significant to the
user's hearing perception. For an OTC hearing aid, we consider these
characteristics to include the frequency-dependent output profile and
the output volume. The controls must allow the user to select the
output volume and profile according to preference. The user may control
the output profile, for example, with a physical toggle switch, a
selection through a software interface, or providing preferences for
software to select the optimal profile dynamically.
FDA views customization as a more-general concept than self-
fitting. Fitting is a customization process that instills in the device
frequency-dependent settings for the specific user. A self-fitting
process instills frequency-dependent settings through the user
interacting with the device or an accessory to the device. Self-fitting
hearing aids incorporate technology, including software, that
integrates user input with a self-fitting strategy and enables users to
independently derive and customize their hearing aid fitting and
settings (see Sec. 874.3325(a)). A self-fitting strategy is a fitting
process, with the selected output profile intended to correspond to the
user's audiogram more closely than a hearing aid that is not fitted.
Many hearing aids that are customizable but not fitted have a limited
set of standardized output profiles, often called ``presets.''
In considering whether a hearing aid is self-fitting, FDA takes
into account, among other things, the device's design and labeling. For
purposes of distinguishing fitting a hearing aid from selecting among
standardized output profiles, we focus on the determination and
configuration of device settings that would be appropriate for the
specific user, especially the frequency-dependent settings. (However,
this focus does not exclude other factors that would still be relevant
to determining intended use.) For example, a hearing aid outputting a
preset likely would not be self-fitting, but a hearing aid that allowed
the user to make frequency-dependent modifications to a preset to suit
the user's preferences likely would be self-fitting.
FDA recognizes that, because a preset may approach a user's ideal
fitting, a device with several presets may be difficult to distinguish
from a self-fitting device. However, we note that devices with a small
number of presets, for example, three, are not ordinarily considered
self-fitting when the user chooses the profile. However, a hearing aid
with a greater number of profiles would more closely resemble a fitting
process, with the selected output profile intended to correspond to the
user's audiogram more closely, in which case the hearing aid likely
would be considered self-fitting. Similarly, toggling between a small
number of programs, for example, for noise reduction or scene
selection, would generally not indicate self-fitting, but setting or
adjusting compression knee points in frequency sub-bands, would tend to
indicate self-fitting. Moreover, FDA would likely consider a device
that includes self-fitting functionality to be self-fitting, regardless
of whether the individual user takes advantage of the functionality.
In sum, customization need not entail self-fitting, though self-
fitting is a kind of customization. Whether a hearing aid is self-
fitting depends on its intended use, which may be shown by, among other
things, the device's design and labeling (see Sec. 801.4 (21 CFR
801.4)). Some limited feature sets would not ordinarily cause a device
to be a self-fitting hearing aid, while more advanced adjustment
capability, especially for frequency-dependent settings, would tend to
indicate that the device is a self-fitting hearing aid. FDA has made a
minor revision to the requirement to provide specific instructions for
use of tools, tests, or software to clarify that such instructions need
not always refer to self-fitting; such instructions must include
instructions for self-fitting only when the OTC hearing aid is a self-
fitting device (see final Sec. 800.30(c)(2)(vii)(B)).
(Comment 2) Many comments urged FDA: to clarify that the definition
of OTC hearing aids under section 520(q)(1)(A) of the FD&C Act is
synonymous with the identification for self-fitting air-conduction
hearing aids under Sec. 874.3325(a); to declare that self-fitting
hearing aids are OTC devices; to declare that OTC hearing aids must be
self-fitting; and/or to require that OTC hearing aid labeling bear the
description ``self-fitting'' or a similar description.
(Response) Although FDA expects that many OTC hearing aids will be
self-fitting, we do not agree with these comments. As explained in the
response to Comment 1, a hearing aid may be customizable in the manner
required under section 520(q)(1)(A)(iii) of the FD&C Act yet not be
intended to entail fitting. Thus, we are not requiring that OTC hearing
aids be self-fitting devices.
By extension, we are not requiring in this final rule that OTC
hearing aids bear labeling that describes the devices as ``self-
fitting'' or a similar description. However, Sec. 801.61 (21 CFR
801.61) still applies, and this provision requires, among other things,
a statement of identity on the principal display panel of an OTC
device. (See also the responses to Comment 21, regarding other
considerations for self-fitting
[[Page 50704]]
capabilities of OTC hearing aids, and Comment 18, regarding identifying
and selling OTC hearing aids.)
Moreover, FDA intends that any hearing aid that uses the same
fundamental scientific technology as those defined under Sec. Sec.
874.3300(a) (21 CFR 874.3300(a)), 874.3305 (21 CFR 874.3305), and
874.3325 (21 CFR 874.3325) qualify as an OTC hearing aid (provided it
satisfies all other applicable requirements). Some future hearing aid
device types may also meet the statutory definition (and satisfy all
other applicable requirements) to be available over the counter.
Requiring that OTC hearing aids be a currently classified air-
conduction hearing aid could have the effect of limiting the OTC
category to current technologies rather than allowing the category to
extend to new types of hearing aids.
(Comment 3) Some comments requested clarification on what would
qualify as ``tools, tests, or software'' for the purposes of
controlling an OTC hearing aid and customizing it to the user's hearing
needs. Similar comments requested that FDA clarify which legacy and
wireless air-conduction hearing aids would satisfy the customization
requirement but not be a self-fitting hearing aid.
(Response) FDA interprets the requirement for tools, tests, or
software broadly. We would, for example, consider a device that allows
the user to cycle through output profiles with a push-button selector
switch and to set the volume with a knob to meet the requirement.
Should such a hearing aid be sufficiently customizable, and should it
not incorporate wireless or self-fitting technology, then it would
presumably be an air-conduction (``legacy'') hearing aid classified
under Sec. 874.3300 and could be made available OTC. (See the response
to Comment 1 for more about distinguishing customization and fitting.)
(Comment 4) Comments expressed concerns about the potential to
bypass premarket notification requirements and special controls if non-
self-fitting hearing aids could be later configured or modified, for
example, if the manufacturer ``unlocks'' self-fitting software or
provides the user with options for ``advanced settings'' or the like.
They urged FDA to finalize rules to prevent such an outcome.
(Response) Existing requirements already address modifications to
devices, including hearing aids. Under Sec. 807.81(a)(3) (21 CFR
807.81(a)(3)), a 510(k) is required if the device is about to be
significantly changed or modified, namely, a major change or
modification in the intended use or other kind of change or
modification that could significantly affect the safety or
effectiveness of the device. For example, a change or modification that
causes a device to fall within a different classification regulation
would be considered significant. Additionally, as explained in the
response to Comment 1, aspects of the device's design and labeling can
demonstrate the device's intended use (see Sec. 801.4). If a wireless
air-conduction hearing aid later incorporates self-fitting technology
(for example, by downloading software) or such technology is later made
accessible to the user (for example, by ``unlocking'' after an
additional purchase), such a change would almost certainly demonstrate
that the modified device was a self-fitting air-conduction hearing aid
classified under Sec. 874.3325 (assuming it was not a new device
type). As such, it would be subject to the premarket notification
requirements and special controls that apply to self-fitting air-
conduction hearing aids.
In sum, a change in intended use or other aspect can cause a change
in applicable requirements, and a device must comply with applicable
regulatory requirements. As such, if a manufacturer intends to unlock
or similarly upgrade its hearing aid with self-fitting technology such
that it would fall within the self-fitting air-conduction hearing aid
classification regulation, then prior to initial introduction into
interstate commerce of the device, the manufacturer must comply with
applicable requirements, including 510(k) requirements and compliance
with the special controls. (See also the response to Comment 6 about
the information a 510(k) should include.)
(Comment 5) Several comments requested clarification on when
manufacturers of OTC hearing aids would need to submit a premarket
notification, also called a 510(k). Many of these comments urged FDA to
require 510(k)s for all OTC hearing aids.
(Response) FDA's existing requirements and related policies for
submitting 510(k)s apply to hearing aids intended for OTC availability
and use. We are not imposing additional general requirements for
510(k)s.
For manufacturers that have already legally introduced self-fitting
air-conduction hearing aids into interstate commerce, changes to their
devices to satisfy the OTC Hearing Aid Controls may require submission
of a 510(k). However, in certain situations FDA intends not to enforce
the requirement for a 510(k), as discussed in section VI on effective
and compliance dates.
This policy also applies to non-self-fitting devices (wireless air-
conduction and legacy air-conduction hearing aids). However,
manufacturers of non-self-fitting devices may wish to consider the
implications of using a test for somebody besides the user to fit the
device. For devices intended for fitting based off of a user-supplied
audiogram, a requirement for the involvement of a licensed person to
produce the audiogram may cause the device not to be an OTC hearing aid
as defined in section 520(q)(1)(A) of the FD&C Act.
Further, if a manufacturer or other non-licensed person obtains
hearing ability data to customize (or even fit) a hearing aid, the
manufacturer should consider whether the instrument used to obtain the
data is a diagnostic (or other) device. Using a hearing aid with a
diagnostic device may implicate changes to a hearing aid concerning the
compatibility or interoperability with other devices, including other
components or accessories, that could significantly affect the hearing
aid's risk profile, necessitating a 510(k).
Notwithstanding these general principles, in each case,
manufacturers should evaluate any changes in light of FDA's guidance,
``Deciding When to Submit a 510(k) for a Change to an Existing
Device,'' issued October 25, 2017, which describes specific changes
that generally do or do not require premarket notification.\1\
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\1\ The document is available online at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device.
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To illustrate: If a manufacturer of a wireless air-conduction
hearing aid updates device labeling and adds a user self-assessment
test intending the test to enable the user to independently customize
and derive the fitting and settings (the device is intended to entail
fitting), then FDA would anticipate the manufacturer would need to
submit a 510(k). FDA's guidance document lists several considerations
that would likely apply. In this example, the changes included:
the directions for use, including the use and application of the
self-test to the device settings (see A4 of the aforementioned guidance
on deciding when to submit a 510(k), ``Could the change affect the
directions for use of the device?'');
the control mechanism and/or operating principle (see B2 of the
same guidance, ``Is it a control mechanism, operating principle, or
energy type change?'');
the device's design, specifically changes to its performance,
components
[[Page 50705]]
or accessories, and human factors of the interface (see B5 of the same
guidance, ``Is it any other change in design (e.g., dimensions,
performance specifications, wireless communication, components or
accessories, or the patient/user interface)?''); and
those that significantly affect its use, potentially necessitating
clinical validation data (see B5.1 and B5.3 of the same guidance,
``Does the change significantly affect the use of the device?'' and
``Are clinical data necessary to evaluate safety or effectiveness for
purposes of design validation?'').
Each of those changes in this example could require a 510(k),
depending on the specifics of the changes. In deciding whether to
submit a 510(k), manufacturers may want to review the guidance in its
entirety since the considerations for the example are not exhaustive
and may or may not be applicable, depending on the specific device.
Manufacturers may also want to review FDA's guidance, ``Deciding When
to Submit a 510(k) for a Software Change to an Existing Device,''
issued October 25, 2017.\2\
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\2\ The document is available online at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-software-change-existing-device.
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Note that, although a wireless air-conduction hearing aid
classified under Sec. 874.3305, or a legacy air-conduction hearing aid
classified under Sec. 874.3300, is exempt from requirements for
premarket notification, some changes could exceed the limitations of
exemption under Sec. 874.9 (21 CFR 874.9), depending on the specifics.
(Comment 6) Commenters requested clear guidance on the specific
information manufacturers would need to submit in a 510(k) to bring
devices to market quickly, avoiding unnecessary delays or unnecessarily
hindering innovation.
(Response) In addition to the required information specified in the
510(k) procedures under 21 CFR part 807, subpart E, the specific
information that a manufacturer should submit will vary based on the
new device or specific changes made to an existing device. Therefore,
providing specific guidance for all manufacturers in this final rule is
not feasible. However, FDA's usual policies on the content and format
of 510(k)s apply to submissions for hearing aids, including for
modifications made to satisfy applicable special controls and the OTC
Hearing Aid Controls. Manufacturers may wish to review publicly
available information regarding the De Novo classification of self-
fitting air-conduction hearing aids. (See the response to Comment 5
regarding when to submit a 510(k).)
In the case of OTC hearing aids, we anticipate that many
manufacturers that submit a 510(k) could avail themselves of the
Abbreviated 510(k) Program, as described in FDA's guidance of that
name, issued on September 13, 2019.\3\ Should a manufacturer
incorporate self-fitting (or other) technology into one of its existing
legacy or wireless devices and need to submit a 510(k), we would expect
that the manufacturer could leverage the similarity with exempt devices
as a least-burdensome way to obtain marketing authorization for the
device that is not exempt from premarket notification requirements.
Manufacturers of existing devices may not need to re-address questions,
for example, related to electromagnetic compatibility (EMC), provided
the manufacturer has not made changes that would affect EMC and require
a 510(k) under our usual policies. Further, summary reports describing
how the hearing aid complies with applicable special controls may be
especially useful in addressing clinical data that support the
effectiveness of the self-fitting strategy, usability testing, and
software verification, validation, and hazard analysis.
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\3\ The document is available online at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/abbreviated-510k-program.
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Moreover, manufacturers that have decided to submit a 510(k),
whether traditional or abbreviated, may wish to review FDA's guidance,
``Format for Traditional and Abbreviated 510(k)s,'' issued on September
13, 2019.\4\ The guidance provides a general framework for the format
and content of a 510(k).
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\4\ The document is available online at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/format-traditional-and-abbreviated-510ks.
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(Comment 7) Commenters requested that FDA exempt certain kinds of
hearing aids, including self-fitting devices, from premarket
notification requirements. Some posited that FDA would accrue
sufficient experience with self-fitting air-conduction hearing aids to
evaluate the potential for 510(k) exemption 2 years after the effective
date of this final rule. Others requested that FDA explain how OTC
hearing aids will become 510(k)-exempt.
(Response) FDA's usual policies for exempting devices from
premarket notification requirements apply to self-fitting air-
conduction hearing aids. Stakeholders may wish to review FDA's
guidance, ``Procedures for Class II Device Exemptions from Premarket
Notification,'' issued February 19, 1998.\5\ The guidance lists several
factors that FDA may consider for exemption, including:
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\5\ The document is available online at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/procedures-class-ii-device-exemptions-premarket-notification-guidance-industry-and-cdrh-staff.
The history (if any) of false or misleading claims or of risks
associated with inherent characteristics of the device, such as
device design or materials (FDA considers the risks associated with
false or misleading claims, and the frequency, persistence, cause,
or seriousness of the inherent risks of the device);
How characteristics of the device necessary for its safe and
effectiveness performance are well established;
How changes in the device that could affect safety or
effectiveness will either be readily detectable or not materially
increase the risk of injury, incorrect diagnosis, or ineffective
treatment;
How any changes to the device would not be likely to result in a
change in the device's classification; and
The role of the limitations of exemption.
Although the amount of time that has passed since the
classification of the device in question may affect how FDA views the
factors, for example, the history of false or misleading claims, the
amount of time since classification is not generally directly relevant.
That is, 2 years after the effective date of this final rule may or may
not afford sufficient experience and information to exempt all self-
fitting air-conduction hearing aids from premarket notification
requirements. We did not propose to exempt self-fitting air-conduction
hearing aids and are not doing so now (see 86 FR 58150 at 58171).
B. Scope (Sec. 800.30(a))
We received several comments on which devices should be subject to
the OTC Hearing Aid Controls and, conversely, which devices should be
prescription. Sometimes these comments referred to definitions rather
than scope. In this section, we respond to comments on scope, including
comments where the suggested changes to the definitions affect the
scope. The next section of this document, specifically for definitions,
responds to comments that relate more directly to the clarity of terms
or the usefulness of different terms.
(Comment 8) Comments requested clarification on the applicability
of the OTC Hearing Aid Controls in circumstances in which software
intended for compensation for hearing loss operates or adapts the
output of other hearing products such as earbuds or headphones.
[[Page 50706]]
(Response) To date, FDA has not classified a device that adapts the
output of other hearing products, such as earbuds, to compensate for
perceived mild to moderate hearing impairment, including a device that
accomplishes this through software. Overall, FDA encourages innovation
of hearing products that are safe and effective and, to that end,
intends to consider developing guidance to provide clarification on the
applicability of laws and regulations implemented by FDA in
circumstances where software would operate or adapt the output of
hearing products to compensate for perceived mild to moderate hearing
impairment. However, considering that in such circumstances, the
software might be distributed separately from the hearing product, FDA
has added requirements in the OTC Hearing Aid Controls for software
device labeling. Similar requirements for software device labeling were
also added to Sec. 801.422. (See Additional Revision 3 in section
III.D.6 describing the labeling requirements for hearing aid
software.\6\) The software device labeling requirements take into
consideration certain aspects associated with software not distributed
with the hearing product, including that such software may not be
provided in a package.
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\6\ We refer to ``additional revisions'' to indicate changes
that FDA has made in further consideration of comments and the
issues involved in this rulemaking, but that are additional to the
suggestions made explicitly in comments. We have numbered the
Additional Revisions in the order that they appear in this document,
which depends upon the subject of the revision--definitions, outside
package labeling, etc.--not the order in which the Additional
Revisions are cross-referenced in our responses to comments.
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(Comment 9) A comment questioned whether a software interface for
professionals such as audiologists or hearing instrument specialists
would cause a hearing aid to be a prescription device if the
professional could adjust the output in excess of the applicable limit.
(Response) If a manufacturer markets an OTC hearing aid that meets
the OTC hearing aid definition and complies with all applicable
requirements of the OTC Hearing Aid Controls--but also offers an
additional separate feature, a software interface for professionals
that allows only licensed persons to adjust the device output--FDA
likely would not consider the hearing aid to be a prescription device,
but the software interface for professionals would be a prescription
device and therefore must comply with Sec. Sec. 801.422 and 801.109.
(Note that a software interface for an air-conduction hearing aid,
which is the subject of this response, would be distinct from the
hypothetical hearing-aid software device, described in the response to
Comment 8, that operates or adapts the output of other hearing products
such as earbuds or headphones.)
However, the intended use of a device can change after initial
introduction into interstate commerce (see Sec. 801.4). If a
manufacturer intends prescription uses of a device, the manufacturer
should consider how to ensure the device will satisfy all applicable
requirements, for example, prescription labeling requirements. Should a
manufacturer provide or allow users, and not just licensed persons,
ready access to an interface that allows the user to configure the
device to provide output in excess of that allowed for OTC hearing
aids, this would indicate the device is intended for users (not limited
to licensed persons) to set an excessively high output. FDA would be
more likely to determine that the intended use was not for perceived
mild to moderate hearing impairment. Additionally, such a device would
not meet the required output limits in the OTC Hearing Aid Controls.
Therefore, such a device would be considered a prescription hearing aid
and must meet applicable requirements, including those under Sec. Sec.
801.422 and 801.109; otherwise, it would be in violation of the FD&C
Act.
(Comment 10) Some comments suggested that FDA limit the scope of
the OTC Hearing Aid Controls to devices intended only for people with
perceived mild, but not moderate, hearing impairment. Some of these
comments suggested that perceived moderate hearing impairment requires
the involvement of a licensed person for successful treatment, and as
such, hearing aids intended for perceived moderate hearing impairment
should not be available over the counter.
(Response) FDA disagrees that the involvement of a licensed person
is necessary for hearing aids intended for perceived moderate hearing
impairment. We are retaining perceived moderate hearing impairment
within the scope of the OTC Hearing Aid Controls. The question of
whether the involvement of a licensed person would benefit an
individual's hearing healthcare is separate from whether the individual
would benefit from the use of an OTC hearing aid. In other
circumstances, the availability and use of OTC medical products to
treat an illness or impairment does not imply the illness or impairment
is not serious. Similarly, the availability and use of OTC medical
products does not negate the benefit of a licensed person's
involvement. FDA considers the use of OTC hearing aids, even when
intended for perceived moderate hearing impairment, to be such a set of
circumstances.
Further, by statute, OTC hearing aids include devices that are
intended to compensate for perceived moderate hearing impairment, and
such devices are to be available to consumers over the counter without
the involvement of a licensed person (see 21 U.S.C. 360j(q)(1)(A)(ii)
and (v)). Section 709(b) of FDARA requires FDA to issue regulations
that include, among other requirements, provisions for reasonable
assurance of safety and effectiveness. This rule will provide
reasonable assurance of safety and effectiveness, without the
involvement of a licensed person, for OTC hearing aids, including for
hearing aids intended for perceived moderate hearing impairment.
Thus, while the involvement of a licensed person may benefit people
with perceived hearing impairment, whether of a mild or moderate
degree, FDA does not agree that consumers must attempt to obtain such a
benefit prior to purchasing hearing aids over the counter. FDA is
maintaining perceived moderate hearing impairment within the scope of
the OTC Hearing Aid Controls.
(Comment 11) Some comments objected to the inclusion of
``perceived'' when referring to the kind of hearing impairment for
which OTC hearing aids are intended. The commenters express concern
that a person's perception of hearing loss may be too subjective, and
that the use of OTC hearing aids should be based on more objective
measures. Some of the comments suggested that FDA require prospective
users to obtain audiograms, which are graphs or test results showing
the person's ability to hear different frequencies, from a licensed
person prior to purchasing an OTC hearing aid.
Besides obtaining an audiogram, other comments suggested a more
general testing or examination requirement by a licensed person for
prospective users, prior to purchase. In this way, these commenters
suggested, OTC hearing aid users would have more certainty that OTC
hearing aids would appropriately compensate for their hearing
impairment, and/or the prospective user does not have an underlying,
medically treatable cause of hearing impairment, for example, one of
the ``red flag'' conditions. (A ``red flag'' condition is a sign or
symptom that should prompt a consultation with a doctor, preferably an
ear-nose-throat doctor.)
(Response) FDA disagrees. We are retaining ``perceived'' in
reference to a
[[Page 50707]]
person's degree of hearing impairment and the intended use of OTC
hearing aids for legal and policy reasons. The term ``perceived'' is
used in section 520(q)(1)(A)(ii) of the FD&C Act to describe the
intended use for OTC hearing aids. Moreover, objective measurements of
hearing impairment are not necessary for reasonable assurance of safety
and effectiveness of OTC hearing aids.
Relying on perceptions of hearing impairment is also appropriate
because the type and degree of impairment exist on a continuum, as does
a person's perception and experience of the impairment. A given degree
(quantification) of hearing impairment will not necessarily reflect
whether an OTC hearing aid is likely to benefit a specific individual.
We have therefore focused on communication and other perceptual
experiences (such as listening to music) in which an intended user is
likely to suspect or notice--that is, to perceive--hearing impairment.
FDA expects this approach based on perception to assist users and
prospective users better than an approach that does not.
Additionally, while FDA agrees that an audiogram would provide a
prospective user with an objective measure of hearing impairment, we do
not agree that the scope of the OTC Hearing Aid Controls should include
only hearing aids for objectively measured impairments. Such a
limitation is counter to the objectives of section 709 of FDARA,
including making available hearing aids OTC, without the involvement of
a licensed person, to consumers through in-person transactions, by
mail, or online.
We acknowledge that this places some onus on users and prospective
users. However, this is the case with respect to OTC availability of
many medical products, and we are establishing requirements that will
provide reasonable assurance of safety and effectiveness for such
availability of hearing aids. We also observe that, while an audiogram
might help a user or a licensed person tailor the hearing aid, or
initially select it, even a hearing health care provider would still
ask the user how the device sounds to the user. The user's perception
would help the hearing health care provider make further adjustments. A
person's desire to seek and use hearing aids depends more directly upon
that person's perception of their hearing impairment than the
definitive degree of impairment, and even a licensed person fitting and
adjusting the device would also account for the user's perception. (See
also the response to Comment 24 about defining hearing loss
numerically.)
Further, FDA has included information in the labeling requirements
for OTC hearing aids intended to help users understand whether the
devices are suitable based on their perceptions, realistic expectations
for hearing aid use, and suggestions on when to obtain professional
assistance before and after purchase. Should prospective OTC hearing
aid users still feel uncertain about their perceptions of impairment,
notwithstanding the availability of the aforementioned information,
they may choose to obtain or undergo professional testing prior to
purchase.
(Comment 12) Some commenters suggested that FDA require a
prescription for OTC hearing aids.
(Response) FDA disagrees. Requiring a prescription to purchase an
OTC hearing aid would be contrary to the purposes of this rulemaking,
the definition of OTC hearing aids in the FD&C Act, and FDARA which
includes the mandate to establish requirements for hearing aids to be
available over the counter (see section 520(q)(1)(A)(v) of the FD&C Act
and section 709(b)(1) and (b)(2)(D) of FDARA). It also would negate the
probable health benefits created by wider availability of hearing aids,
as we described in the proposal (see 86 FR 58150 at 58152).
(Comment 13) Multiple comments suggested FDA remove dispensing from
the list of commercial activities that FDA included in the definition
of ``licensed person.'' The definition listed commercial activities
involving OTC hearing aids for which a State or locality could not
require the involvement of a licensed person. For example, a State
could not require a person representing as a dispenser of OTC hearing
aids to undertake special licensing or equivalent activities solely for
that reason.
Such comments cited various reasons, for example, that State
regulatory regimes impose obligations on people representing as
dispensers, so referring to the term in the OTC Hearing Aid Controls
would create an inconsistency with State regulatory requirements. Other
comments pointed out that people expect dispensers to have licenses,
and FDA's regulations would be inconsistent with such expectations.
Still others cited the need for dispensers to acquire and/or
demonstrate qualifications prior to dispensing OTC hearing aids.
Similar comments suggested that FDA instead refer to dispensers as
``sellers,'' ``vendors,'' ``merchants,'' or other such terms. These
terms, the comments assert, would distinguish salespeople from hearing
health care providers.
(Response) FDA is not modifying the scope of the OTC Hearing Aid
Controls or the definition of ``licensed person'' to exclude dispensing
of OTC Hearing Aids. As we explained in the proposed rule, FDARA lists
certain activities that may be undertaken with respect to OTC hearing
aids for which a State or locality cannot require the involvement of a
licensed person (see 86 FR 58150 at 58158). One such activity that
FDARA explicitly lists is the dispensing of OTC hearing aids. This
means that, under Federal law, a State or locality cannot require a
dispenser of OTC hearing aids to undertake special licensing or
equivalent activities because that would in essence require the
involvement of a licensed person, contrary to section 709(b)(2)(D) of
FDARA and section 520(q)(1)(A)(v) of the FD&C Act.
Additionally, in establishing the OTC category for hearing aids, we
have developed requirements to provide reasonable assurance of safety
and effectiveness for OTC hearing aids without the involvement of a
licensed person (see section 709(b)(2) of FDARA). Imposing special
licensing requirements or equivalent activities, therefore, is not
necessary to provide reasonable assurance of safety and effectiveness
of OTC hearing aids. Although not required, a purchaser of OTC hearing
aids can still seek the assistance of a licensed person when selecting
a hearing aid.
Since a person may dispense OTC hearing aids without a specialized
license or the need to involve a licensed person, referring to
dispensers by another term such as ``vendor'' or ``seller'' is not
necessary to distinguish dispensing from activities requiring
specialized licensure or the involvement of a licensed person.
Moreover, we have previously defined dispensers as persons engaged in
the sale, lease, or rental of hearing aids (see prior Sec.
801.420(a)(3)). The regulations we are finalizing in this rulemaking
use essentially the same definition. In sum, using alternative titles
for dispensers may serve to confuse consumers by unnecessarily
establishing another term for a legally permissible activity as well as
incorrectly implying that FDA's interpretation of the term has changed.
FDA recognizes that State and local requirements sometimes
incorporate the term ``dispenser,'' and multiple States impose
requirements on account of dispensing hearing aids. However, FDARA
section 709(b)(4), to summarize, provides that no State or local
government shall continue in effect certain State or local requirements
that are different from, in addition to, or otherwise not identical to
the
[[Page 50708]]
regulations issued under FDARA section 709(b). Thus, regardless of
whether a State or locality amends or otherwise updates its
requirements, it may not continue in effect the inconsistent
requirements prior to their amendment or repeal.
As we explained in the proposal, despite the fact that licensure is
not required for dispensing OTC hearing aids, some persons may
voluntarily identify as a ``licensed dispenser,'' (see 86 FR 58150 at
58168). Although a State or locality could not require dispensers (or
other persons) to undertake special licensing solely on account of
commercial activity involving OTC hearing aids, a State or locality
could still establish licensure criteria that would apply to those
voluntarily identifying as licensed persons. In such a case, the
dispenser's identification as a licensed person would imply that the
dispenser complies with applicable State or local licensing
requirements, albeit voluntarily. (See also the responses to Comment
15, discussing other licensing considerations, and Comment 127,
discussing the involvement of a licensed person for prescription
hearing aids.)
In sum, in light of Federal statutory and other requirements,
including those that provide reasonable assurance of safety and
effectiveness of OTC hearing aids, FDA is not narrowing the scope of
the OTC Hearing Aid Controls to exclude dispensing. This does not,
however, prevent dispensers of OTC hearing aids from voluntarily
subjecting themselves to State or local licensing requirements to
obtain a license (or its equivalent).
(Comment 14) Comments suggested that OTC hearing aids be available
for all degrees of hearing impairment, including degrees greater than
moderate. Some of these comments further noted that Medicare does not
currently pay for or reimburse the cost of hearing aids. As such, the
comments asserted that OTC hearing aids should be usable as lower-cost
alternatives to prescription hearing aids for individuals with more-
profound impairments.
(Response) For the reasons explained in the response to Comment 10,
FDA is establishing requirements for perceived mild to moderate hearing
impairment. Thus, the appropriate device output limit that we are
establishing would not extend to hearing impairment that would require
a greater output than that which is appropriate for perceived moderate
hearing impairment.
However, devices of the same type may generally be intended either
for prescription or OTC use. For example, a manufacturer marketing an
OTC wireless hearing aid could also market another wireless hearing aid
with a higher output than that permitted for OTC hearing aids. This
higher output would render it a prescription device. As with other
products that have differing uses but share manufacturing similarities,
a hearing aid manufacturer may be able to realize economies of scale by
selling an OTC version and a prescription version of hearing aids that
fall within the same type, which in turn could lower the prices for
prescription hearing aids. (See also the response to Comment 17 about
limitations on FDA's authority to require reimbursement for devices.)
(Comment 15) Some comments suggested FDA define which activities
involving hearing aids would require licensure.
(Response) FDA does not generally determine which activities
involving medical products require licensure. However, section
709(b)(4) of FDARA lists several activities for which States or
localities may not require specialized licensure for, or the
involvement of a licensed person in, commercial activity involving OTC
hearing aids. These listed activities are the servicing, marketing,
sale, dispensing, use, customer support, or distribution of OTC hearing
aids through in-person transactions, by mail, or online. As we
explained in the proposal, we interpret the listed activities broadly,
so for example, the term ``sale'' would include leases or rentals (see
86 FR 58150 at 58165).
States usually determine the requirements for licensure or the
involvement of licensed persons. States may still do so with respect to
hearing aids when not prohibited by section 709(b)(4) of FDARA (and
other applicable laws). Where section 709(b)(4) of FDARA does not list
an activity, when construing the terms broadly, a State may require
licensure for that activity as it relates to OTC hearing aids. We note
that the proposal provided a discussion and some examples (see 86 FR
58150 at 58167-58168). Thus, for example, a State may require a license
for a hearing aid fitter, because ``fitting'' is not listed among the
activities in section 709(b)(4) of FDARA, and we do not interpret any
of the listed activities to include fitting. A person could not be a
fitter in that State, even for OTC hearing aids, without a license.
However, the State could not require a hearing aid fitting prior to a
user purchasing an OTC hearing aid because that would restrict or
interfere with commercial activity involving OTC hearing aids. See the
response to Comment 13 for further explanation.
Thus, a State may still establish criteria for licensing dispensers
should a person voluntarily decide to become a licensed dispenser of
OTC hearing aids. In other words, although a State cannot require a
license for dispensing OTC hearing aids, a State can establish what a
person must do to obtain, and claim to have, a license for dispensing
hearing aids. FDA expects that States may wish to continue in effect
licensing requirements to dispense prescription hearing aids, and we
expect that some hearing aid dispensers may wish to obtain a license in
the event they desire to advertise as ``licensed'' and/or to sell
prescription hearing aids in addition to OTC hearing aids.
(Comment 16) Some comments urged FDA to limit the scope of OTC
availability as much as possible, at least in the beginning. These
comments conveyed concerns for the absence of a licensed person in
various roles, including education and counseling. One such comment
suggested that a more-limited scope would be easier to broaden later
than the reverse, limiting a broader scope.
(Response) In the proposed rule, we explained that several barriers
likely impede people's access to hearing aids, including among others,
Federal and State regulatory requirements (see 86 FR 58150 at 58152,
58154). We are undertaking this rulemaking in part to remove or reduce
such barriers to access by establishing requirements that will provide
reasonable assurance of safety and effectiveness while encouraging
broad availability (see 86 FR 58150 at 58158). Moreover, we received a
wealth of thoughtful and nuanced comments about the scope of the OTC
Hearing Aid Controls, including this Comment, and we have determined
that a more-restrictive approach is not necessary for reasonable
assurance of safety and effectiveness of OTC hearing aids. Considering
our purpose to broaden access and our determinations regarding
reasonable assurance of safety and effectiveness, we do not agree that
narrowing the scope of the OTC Hearing Aid Controls, with the intention
of considering a broader scope later, is currently an appropriate
strategy.
(Comment 17) Some comments noted the role of health insurers,
including Medicare, in a person's ability to obtain hearing aids.
Comments suggested that FDA focus on payments or reimbursements for
hearing aids, potentially including financial incentives.
(Response) FDA does not have authority to require payors to pay for
or reimburse the cost of hearing aids or to offer financial incentives
to obtain the
[[Page 50709]]
devices. However, we intend this rule, among other ends, to broaden
access to hearing aids by eliminating certain kinds of requirements
that likely add to the cost of accessing the devices. For example, we
are establishing rules to make OTC hearing aids available without the
involvement of a licensed person.
C. Definitions (Sec. Sec. 800.30(b) and 801.422(b))
This section focuses on explaining the final definitions.
Generally, commenters sought clarity, and we have generally accepted or
declined suggestions with the goal of improving clarity of the
definitions.
(Comment 18) Multiple comments proposed that FDA use another name
to identify OTC hearing aids. For example, some comments proposed
``over-the-counter hearing device,'' ``self-fit over-the-counter
hearing device,'' ``hearing amplifiers,'' and ``hearing devices.''
Generally, these commenters sought to avoid confusion with existing
devices for both consumers and State regulators. Otherwise, commenters
believed, consumers may be misled into believing that OTC hearing aids
are equivalent to prescription hearing aids with respect to
performance, safety, and effectiveness, and there may be regulatory
issues for State licensing boards. Other comments argued that the
availability of OTC devices through retailers such as grocery or
department stores would suggest that these devices are not hearing
aids, so referring to them as such would be inappropriate.
By identifying OTC hearing aids in a different way, consumers,
regulators, and other stakeholders would, the comments argued, have a
clearer indication of devices subject to the new regulatory category.
Many such comments noted that the use of a term other than ``hearing
aid'' was recommended by the National Academies of Sciences,
Engineering, and Medicine (NASEM) in their report, ``Hearing Health
Care for Adults: Priorities for Improving Access and Affordability,''
and by the Hearing Care Associations in their Consensus Paper,
``Regulatory Recommendations for OTC Hearing Aids: Safety &
Effectiveness'' (Ref. 7).
(Response) FDA will continue to use the term ``hearing aids'' to
refer to the OTC and prescription devices subject to this rulemaking
because the use of this term is appropriate. Hearing aids, whether OTC
or prescription, are wearable sound-amplifying devices intended to
compensate for impaired hearing. The term ``hearing aid'' describes
several device types reflected in various classification regulations.
Although OTC hearing aids use air-conduction technology, prescription
hearing aids may do so as well (for example, an air-conduction hearing
aid that provides a higher output than that specified in the OTC
Hearing Aid Controls would be prescription). Therefore, the use of the
term ``hearing aid'' is appropriate to reflect both OTC and
prescription devices that fall within the same device type (for
example, wireless air-conduction hearing aids under Sec. 874.3305).
Moreover, section 520(q)(1)(A) of the FD&C Act explicitly uses and
defines the term ``over-the-counter hearing aid[s],'' and section
709(b)(1) of FDARA requires the establishment of ``a category of over-
the-counter hearing aids.'' Thus, referring to the devices by a
different name would not only be inconsistent with the applicable
classification regulations and statutes, but also FDA expects that
doing so would cause confusion and uncertainty for consumers
considering purchasing an OTC hearing aid.
Further, we expect this rulemaking to broaden the kinds of
retailers that sell OTC hearing aids, helping to increase the
availability of the devices. By extension, the availability of OTC
hearing aids (by that name) in grocery and department stores would help
fulfill one of the purposes of this final rule. Moreover, many
technologically similar products are available and go by several names,
including ``personal amplifier.'' Based on their intended use(s), some
of these may not be devices and/or meet applicable requirements for
devices, yet they may appear to some prospective purchasers to be
suitable alternatives to safe and effective devices.\7\ We expect that
consumers are familiar with the name ``hearing aid,'' and using that
name will better support broadened use of the devices. At the same
time, we expect that introducing yet another name for a similar
technology, albeit regulated as a device, would only serve to increase
confusion in the marketplace because prospective purchasers may think
that a hearing aid could be marketed under other names, including those
used for products that do not meet applicable device requirements.
Thus, we have determined that the best way to indicate whether the
device is subject to this rulemaking is to use the name ``hearing aid''
as used for the device types in the applicable classification
regulations, and the name that is established in the FD&C Act and
FDARA, OTC hearing aids.
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\7\ FDA is finalizing a guidance alongside this rulemaking to
help stakeholders distinguish hearing aids from PSAPs. To summarize,
a PSAP is an electronic product intended for non-hearing-impaired
people to amplify sounds in certain environments. A PSAP is not
intended to aid with or compensate for impaired hearing.
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To assist consumers further, as well as ease determining the
applicability of the OTC Hearing Aid Controls, we are modifying the
labeling and conditions for sale for OTC hearing aids. See Additional
Revisions 2 (section III.D.3) and 4 (section III.G), respectively, for
further explanation.
Although the technical specifications are different for OTC hearing
aids and prescription hearing aids, as explained elsewhere in this
document, FDA believes the technical specifications for each category
are appropriate. Additionally, information on the technical
specifications is required to be provided in the device labeling. FDA
believes that OTC hearing aids that comply with Sec. 800.30 and other
applicable requirements (for example, Quality System requirements) will
have reasonable assurance of safety and effectiveness for people aged
18 and older with perceived mild to moderate hearing impairment.
(Comment 19) A comment suggested that the definition of ``hearing
aid'' should include an explicit statement that PSAPs are not hearing
aids. The comment mentioned the draft guidance we are finalizing
concurrently with this final rule, ``Regulatory Requirements for
Hearing Aid Devices and Personal Sound Amplification Products,'' which
is published elsewhere in this issue of the Federal Register and is
also available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/regulatory-requirements-hearing-aid-devices-and-personal-sound-amplification-products, and characterized the draft of
the guidance as ``provid[ing] essential distinctions between [hearing
aids] and PSAPs.''
(Response) FDA agrees that distinguishing between hearing aids
(devices) and PSAPs (non-devices) can be an important interest for
purchasers, manufacturers, and other stakeholders. We are finalizing
requirements for the principal display panel on the package of an OTC
hearing aid to bear the marks ``OTC'' and ``hearing aid'' (see
Additional Revision 2 in section III.D.3). We are also finalizing a
corresponding condition for sale that sellers may only make a hearing
aid available OTC when its package bears the requisite marks (see
Additional Revision 4 in section III.G). Moreover, we are finalizing
the aforementioned draft guidance document, intended to describe
hearing aids, PSAPs, their respective intended uses, and the regulatory
requirements that apply to both types of products.
[[Page 50710]]
We are not, however, modifying the definition of ``hearing aid'' to
state that PSAPs are not hearing aids. As we explained in the proposed
rule, the name of a product on its own would not ordinarily demonstrate
intended use (86 FR 58150 at 58154). Thus, merely excluding PSAPs from
the definition of hearing aid does not remove a product from device
regulation under the FD&C Act if, for example, its labeling
demonstrated that the product was intended to compensate for hearing
loss. We think the actions we are taking will better assist
stakeholders to distinguish between products than modifying the
definition of ``hearing aid'' in the OTC Hearing Aid Controls.
(Comment 20) Some comments suggested adding definitions to the
classification regulation for self-fitting hearing aids (Sec.
874.3325). For example, comments suggested FDA define ``programming the
hearing aid'' and ``self-fitting strategy.''
(Response) FDA is not adding definitions for purposes of the self-
fitting air-conduction hearing aid classification at this time. In
considering possible definitions to add, including those suggested in
the comments, we sought to balance clarity with flexibility. The
phrasing of Sec. 874.3325(a) is intended to cover a range of
technologies, both present and future, without unduly constraining
innovation. For example, the regulation refers to a ``self-fitting
strategy,'' rather than a more prescriptive description. Under this
regulation, manufacturers could choose different strategies to achieve
self-fitting by the user while still being substantially equivalent to
other devices of the same type. After considering the comments, we have
decided not to constrain the classification further.
However, we recognize that these commenters desired to clarify the
classification of different types of air-conduction hearing aids,
including the applicability of special controls and premarket
notification requirements. We have provided our thinking and
expectations in section V.A. of this document to address such concerns.
Further, FDA may issue guidance on this subject in the future following
our Good Guidance Practices and inviting additional comments (see 21
CFR 10.115).
(Comment 21) Several comments requested that FDA define self-
fitting hearing aids in such a way as to clarify that the devices must
be manipulable by the general public. Many of these comments showed
concern about predatory business practices, through which manufacturers
might prevent users from customizing device output, because they did
not view self-fitting capability as clearly required for OTC hearing
aids.
(Response) FDA agrees that OTC hearing aids must be somehow
manipulable by lay users; however, we are not adopting these
suggestions.
As explained in the response to Comment 1, not all OTC hearing aids
are self-fitting devices classified under Sec. 874.3325. Thus, FDA
declines to define self-fitting hearing aids in the way suggested by
comments.
Further, modifying the self-fitting hearing aid classification
regulation in the suggested way is not necessary. By definition, self-
fitting air-conduction hearing aids allow users to program their
hearing aids, and the devices integrate user input with a self-fitting
strategy and enable users to independently derive and customize their
hearing aid fitting and settings. Should users themselves be unable to
derive or customize the fitting and settings independently, or program
their hearing aids, FDA likely would not consider it a self-fitting
air-conduction hearing aid.
More generally, section 520(q)(1)(A)(iii) the FD&C Act defines an
OTC hearing aid, in part, as a device that allows the user to control
the hearing aid and customize it to the user's hearing needs. Should
users of a hearing aid be unable to control and customize the device in
the manner required, the hearing aid would not be an OTC hearing aid as
defined in the FD&C Act or final Sec. 800.30, and thus, would be a
prescription device.
FDA also notes that the FD&C Act, the OTC Hearing Aid Controls, and
the classification regulation for self-fitting air-conduction hearing
aids all refer to the ``user'' of the hearing aid. Referring to
manipulation by the general public may not accurately or adequately
represent the intended user(s) of a hearing aid because the intended
user(s) may differ in significant ways from the general population.
However, FDA agrees that manufacturers should generally assume that
users are laypeople (not experts) regarding OTC hearing aids, and we
are finalizing the definition of ``tools, tests, or software'' as
proposed. The definition specifically requires that a lay user be able
to control and customize an OTC hearing aid. Further, because OTC
hearing aids are not prescription devices (and are not otherwise exempt
from certain labeling requirements), the labeling must include adequate
directions for use, which are directions under which a layperson can
use the device safely and for its intended use(s) (see Sec. 801.5 (21
CFR 801.5)).
(Comment 22) A comment suggested that FDA explicitly require that
users have control of the device output to customize the device to
their hearing needs. This comment argued the phrasing of the definition
for ``tools, tests, or software'' that FDA proposed is ambiguous,
potentially allowing manufacturers to restrict control of the device to
physical fit but not the sound output.
(Response) As explained in the response to Comment 21, section
520(q)(1)(A)(iii) of the FD&C Act defines an OTC hearing aid as a
device that, through tools, tests, or software, allows the user to
control the hearing aid and customize it to the user's hearing needs.
In final Sec. 800.30(b), we define ``tools, tests, or software'' as
components that allow lay users to control the device and customize the
device sufficiently. As explained in the response to Comment 1, we
interpret the requirement for customization to hearing needs to mean
that the device must allow the user to cause frequency-dependent
changes based on the user's preference, and the requirement for user
control to mean that the user can access or select the output
characteristics most significant to the user's hearing perception.
These elements sufficiently describe the requisite controllability and
customization without unnecessarily constraining future technologies
that could be available OTC. We are not modifying the OTC Hearing Aid
Controls as suggested. However, as explained elsewhere in this
document, we added a user-adjustable volume control to the design
requirements for OTC hearing aids so users will be able to control this
aspect of the sound output.
(Comment 23) Comments suggested that FDA include in the definition
of ``used hearing aid'' a stipulation that a bona fide hearing aid
evaluation extend through a trial period that might last as long as 90
days. That is, a device would not be considered a ``used hearing aid''
solely because a prospective purchaser wore it for an extended trial
period, without the presence of the dispenser or a hearing health
professional selected by the dispenser.
(Response) FDA is not adopting this suggestion because purchasers
should be aware of use of the device outside of observation to ensure
appropriate operating conditions. This is because a device will be in
contact with the ultimate user's skin for extended periods, and the
device contains sensitive electronics. Without observation, a device
that a prospective
[[Page 50711]]
user is evaluating may be used in a way that would make the device
unsanitary for the ultimate user, or the device could have been
subjected to damaging conditions.
However, we are revising the definitions and labeling requirements
to clarify labeling terms to convey information better. If a
manufacturer inspects and tests a used hearing aid, makes any necessary
modifications to the hearing aid to ensure it satisfies applicable
requirements to be available OTC, including for labeling,
electroacoustic performance, and design, and the manufacturer has
adequately reprocessed the hearing aid for the next user, then the
manufacturer may describe the device as ``rebuilt'' in the required
labeling rather than ``used.''
(Comment 24) Multiple comments proposed that FDA define mild to
moderate hearing impairment in terms of objective criteria. For
example, these comments suggested that FDA adopt thresholds used by the
American Speech-Language-Hearing Association (ASHA) or the World Health
Organization (WHO) to categorize hearing impairment. Others suggested
more generally that labeling describe hearing impairment in detail so
that prospective OTC hearing aid users would ``understand exactly''
their degree of hearing impairment.
(Response) FDA is declining to define hearing impairment for
purposes of the OTC Hearing Aid Controls in terms of objective
measurements because defining hearing impairment in such a way is
neither necessary for, nor consistent with, establishing an OTC
category of hearing aids.
Inconsistency would arise because the requirements to establish the
OTC category focus on the hearing aid user's perception as well as
making devices available without the involvement of a licensed person.
Specifically, section 520(q)(1)(A)(ii) of the FD&C Act refers to
``perceived'' impairment in defining the intended use of OTC hearing
aids. As explained in the response to Comment 11, the subjective nature
of hearing impairment is integral to the regulatory category we must
establish for OTC hearing aids.
Further, an objective definition based on measurement of hearing
impairment would imply the need to involve a licensed person, such as
an audiologist or hearing instrument specialist, to administer a test
or otherwise provide an exact understanding. However, OTC hearing aids
must be available without the involvement of a licensed person (see 21
U.S.C. 360j(q)(1)(A)(v)), and FDA has determined that an objective
measurement of hearing impairment is not necessary for reasonable
assurance of safety and effectiveness of OTC hearing aids. Thus,
defining the degrees of impairment in objective terms, using one of
several available schemes for categorization, would be contrary to the
purposes of this final rule as well as unnecessary.
We acknowledge that many licensed persons use audiometric
threshold-based hearing loss categories to describe hearing loss
severity, and this information may be useful to OTC hearing aid users
should they choose to seek it out. However, the perception of hearing
difficulties is on a continuum that is not confined to specific
audiometric threshold categories. For example, two people with the same
audiometric thresholds may have different subjective perceptions of,
and different personal preferences for addressing, the impairment. The
intended user population will have a broad range of perceptual
difficulties and communicative function because of the wide variability
and overlap in perception of hearing impairment within and across
hearing loss severity.
The ASHA and WHO hearing loss categories each reflect a continuum
while providing high-level clinical guidance. These categories do not
represent discrete perceptual boundaries for the patient or for the
treating professional. Furthermore, these hearing loss categories were
not formulated to determine regulatory questions such as whether an
individual should have access to OTC hearing aids. We are declining to
adapt and apply such a scheme in that way.
Nonetheless, we are establishing labeling requirements to help
consumers recognize perceived mild to moderate hearing impairment. See
the response to Comment 35 for more on this topic. Further, the
labeling encourages users and prospective users to seek professional
services in several circumstances, and people who wish to measure their
degree of hearing impairment objectively or definitively may still
obtain such measurements voluntarily.
(Comment 25) One comment suggested that the definition of
``prescription hearing aid'' be revised to further state that these
devices are dispensed by a State-licensed professional.
(Response) FDA declines to revise the definition of ``prescription
hearing aid'' as suggested because it is unnecessary. Prescription
hearing aids are prescription devices and as such, they are subject to
Sec. 801.109. Under Sec. 801.109(a), a prescription device is a
device that is: (1) either in the possession of a person, or his agents
or employees, regularly and lawfully engaged in the manufacture,
transportation, storage, or wholesale or retail distribution of such
device or in the possession of a practitioner, such as physicians,
dentists, and veterinarians, licensed by law to use or order the use of
such device and (2) is to be sold only to or on the prescription or
other order of such practitioner for use in the course of his
professional practice. Because prescription hearing aids are required
to be in the possession of persons lawfully engaged in the retail
distribution (or certain other activities) of such devices, and must be
sold only to or on the prescription or other order of a licensed
practitioner, the revision suggested in the comment is unnecessary.
(Additional Revision 1) After further consideration, FDA is
modifying the definition of ``dispenser'' for the purposes of
prescription hearing aids under final Sec. 801.422(b). FDA proposed
that the term refer to any person engaged in the sale of prescription
hearing aids. However, we observed a potential for confusion based on
comments we received, because a person engaged in the sale of OTC
hearing aids would also be a dispenser. Thus, while the definition of
the term in Sec. 801.422(b) is for the purposes of prescription
hearing aid labeling, the definition as proposed may have appeared to
create an inconsistency with the use of the term outside of Sec.
801.422. To avoid the potential inconsistency and confusion, we are
removing ``prescription'' from the final definition of ``dispenser.''
D. Labeling (Sec. 800.30(c))
FDA received many comments related to labeling for OTC hearing
aids. Most of these comments focused on ensuring the information would
be easy to understand for most people, that is, people who are not
professionals in a field related to hearing impairment. Commenters
suggested various means to improve the labeling, including different
phrasing, formatting, or positioning. Others provided general feedback
and emphasized Plain Language principles, and a need to avoid jargon or
overly technical phrasing, to help readers understand information in
the labeling. FDA agrees that Plain Language principles apply in the
case of labeling for hearing aid users, and that Plain Language will
help users to understand the information in the device labeling.
[[Page 50712]]
1. User-Friendly Labeling
(Comment 26) Some comments expressed concern that FDA did not
validate the labeling of the OTC hearing aids. Many of these comments
are concerned that without labeling validation, a consumer's ability to
self-diagnose their hearing loss will be hindered. These comments
suggested that a requirement for manufacturers to validate labeling
will help to ensure that users can properly self-diagnose their hearing
loss.
(Response) FDA is declining to adopt labeling validation
requirements for OTC hearing aids at this time. The labeling
requirements we are finalizing benefitted from extensive input from
many sources, including docket comments and public workshops, such as
the one convened by NASEM. Additionally, self-fitting air-conduction
hearings aids under Sec. 874.3325 are subject to a special control
requiring usability testing, which inherently includes testing the
directions for use by the user. Further, any device must have labeling
bearing adequate directions for use unless subject to an exemption (see
section 502(f)(1) of the FD&C Act and Sec. 801.5). This means that the
directions for use for an OTC hearing aid must allow a lay user to use
the device safely and for its intended purposes (see Sec. 801.5).
Given these requirements, and the extensive input we have received for
labeling, a requirement for additional validation is not needed for
reasonable assurance of safety and effectiveness.
(Comment 27) Multiple comments proposed that labeling refer to an
``Ear-Nose-Throat Doctor,'' ``ENT,'' or similar terms instead of
referring to an ``ear specialist.'' These comments suggested that ``ear
specialist'' is not specific enough because it might imply somebody
besides a physician. For example, it could refer to an audiologist or a
hearing aid dispenser, neither of whom need be a physician. As such,
``ear specialist'' may confuse or inadvertently mislead hearing aid
users.
(Response) FDA agrees that ``ear-nose-throat doctor'' and ``ENT''
are more descriptive and likely more common than ``ear specialist.'' We
have revised labeling throughout to adopt this suggestion when
referring to physicians.
(Comment 28) A comment suggested that labeling refer to
``physicians'' rather than ``doctors'' because people who are not
physicians may be doctors, for example, people who hold Ph.D.s
(philosophical doctors) or chiropractors (some of whom are doctors of
chiropractic).
(Response) We are not adopting this suggestion. We are adopting
suggestions to refer to ``ear-nose-throat doctors'' instead of ``ear
specialists'' to provide better guidance to people who may be
unfamiliar with hearing healthcare delivery (see the response to
Comment 27). However, we do not expect that people will seek the
assistance of philosophical doctors or chiropractors for their hearing
needs just because the labeling for OTC hearing aids refers to a
``doctor'' rather than a ``physician.'' Instead, we expect people who
seek the assistance of a doctor for their hearing needs will exercise
reasonable judgment in discerning which kind of doctor might help them
with their hearing needs, in the same way they might exercise
reasonable judgment to find appropriate providers when suggested by OTC
labeling for other health concerns.
(Comment 29) A comment requested that ``doctor'' and ``physician''
in the labeling be revised to ``licensed healthcare practitioner.'' The
comment argued that use of ``licensed healthcare practitioner'' is
consistent with FDARA and would ensure that patients see qualified
individuals, yet not confuse and limit consumers about whom they can
consult.
(Response) FDA is declining to replace all references to ``doctor''
or ``physician'' with ``licensed healthcare practitioner'' because
there are certain aspects of hearing care where it is warranted that a
patient consult a ``doctor.'' As discussed in the response to Comment
27, FDA is updating the term ``ear specialist'' to ``ear-nose-throat
doctor (ENT)'' to avoid confusion as to whom a consumer should consult.
Where FDA now uses the term ``ENT'' it is to clarify who is best
positioned for a patient to consult on a particular matter. For
example, an ENT would generally be the kind of provider who has the
necessary qualifications and expertise to conduct an examination for
the diagnosis of Red Flag conditions. We acknowledge, however, that not
all hearing healthcare providers need to be physicians and there are
many situations, such as consumers continuing to have difficulty
hearing even after beginning use of OTC hearing aids, where consulting
licensed healthcare providers would be necessary or appropriate.
(Comment 30) A few comments recommended rewording the ``red flag''
condition warnings to present the issue first and then the solution.
Comments suggested the warning should be updated to read, ``[p]rior to
purchasing this device, if you have any of the following you should
promptly consult with a licensed physician, preferably, an Ear-Nose-
Throat (ENT) doctor.''
(Response) FDA agrees that a different presentation would more
effectively communicate the warning. In response to comments proposing
rewording to increase readability, we have retitled the warning and
reordered the introduction in the manner suggested and adopted slightly
different phrasing that we think will be more user-friendly.
(Comment 31) A comment expressed concern about the caution that
hearing aids are not hearing protection. Some comments argued that it
is impracticable for hearing aid users to take out their hearing aids
in situations where a loud sound is passing by. Comments recommended
the caution be updated to advise individuals to mute or turn off their
hearing aids when experiencing a loud sound and only recommend removal
of hearing aids if the hearing aid does not provide any hearing
protection.
(Response) FDA is declining to implement this revision. FDA has
included information in the labeling requirements to help users have
realistic expectations when using hearing aids. This particular caution
is intended to assist users in the day-to-day use of their hearing aid
and to notify them that they should not rely on their hearing aid for
hearing protection. Additionally, the labeling includes a caution that
individuals should turn down the volume or remove the device if the
sound is uncomfortably loud or painful. These two cautions provide
appropriate guidance to help ensure safety when experiencing a loud
sound.
(Comment 32) A few comments requested revisions to the note
regarding expectations about what a hearing aid can do to use more
positive framing. Comments argued that the note was more a notice of
what hearing aids cannot do, and a more positive framing would increase
readability and product desirability.
(Response) FDA agrees that it is important for users to read and
understand the labeling easily, and we have updated the note to include
language about the benefits as well as limitations of OTC hearing aids.
The language was further updated to provide notice that users may need
to wait a few weeks to get used to their hearing aids.
(Comment 33) A few comments requested that FDA require a minimum
font size so that consumers can read and understand the particulars of
each OTC hearing aid. Comments recommended requiring font sizes from
12-14 points.
(Response) FDA is declining to implement this suggestion. This rule
applies to a large number of manufacturers and their various hearing
aids so FDA believes some flexibility is
[[Page 50713]]
warranted. Additionally, we do not believe a minimum font size is
necessary to ensure users can read and understand the labeling for OTC
hearing aids because there are requirements that address this. For
example, under section 502(c) of the FD&C Act, a device is misbranded
if any word, statement, or other information required by or under
authority of the FD&C Act to appear on the label or labeling is not
prominently placed thereon with such conspicuousness and in such terms
as to render it likely to be read and understood by the ordinary
individual under customary conditions of purchase and use (see 21
U.S.C. 352(c)). Given this and other requirements, and the need for
some flexibility as the rule applies to a variety of devices, FDA does
not believe a minimum font size is warranted.
(Comment 34) A few comments recommended that the descriptions of
functions of the hearing aids include figures and videos alongside text
to provide additional clarity on how to use hearing aids.
(Response) To help users after purchase, the inside labeling must
include, among other information, a description of accessories;
illustration(s) of the OTC hearing aid that indicates operating
controls, user adjustments, and battery compartment; adequate
directions for use; technical specifications; and a description of
commonly occurring, avoidable events that could adversely affect or
damage the OTC hearing aid. The labeling requirements will allow a lay
user to use the device safely and for its intended purposes (see Sec.
801.5). The additions suggested by comments are not necessary for
reasonable assurance of safety and effectiveness.
2. User Education
(Comment 35) A comment suggested that device package labeling
describe hearing impairment in terms of common perceptual difficulties.
In specific, it proposed that labeling describe mild impairment as
having difficulty hearing soft-spoken people and young children.
According to the comment, people with mild impairment are often able to
hear loud or more-intense vowel sounds but may miss some of the softer
consonant sounds. Thus, they may have to ask people to speak up or
repeat themselves on occasion. The comment further stated that for
someone with typical hearing, this is comparable to placing a finger in
one's ears.
The comment proposed that labeling describe moderate impairment as
having additional difficulty hearing vowel sounds in addition to
missing consonant sounds. According to the comment, this means that
when someone is speaking at a normal volume, a person with moderate
hearing impairment is unable to hear most of the speech sounds.
Accordingly, people with moderate hearing impairment often comment that
they hear sounds but cannot always understand speech.
(Response) To help users determine whether they have perceived mild
to moderate hearing impairment, FDA has revised the package labeling
requirements by simplifying the language and making it less formal.
(See the response to Comment 41 for more about these revisions.)
However, while we agree that the suggested descriptions may also be
useful for prospective users, other factors impact determining the
labeling requirements. These factors include, for example, the limited
space available for the outside package labeling, as many comments
emphasized, and whether the information is necessary to provide
reasonable assurance of safety and effectiveness. The descriptions
suggested in the comment would add to the length of the material on the
outside packaging for OTC hearing aids. Additionally, the required
information under final Sec. 800.30(c)(1)(B) sufficiently helps to
provide reasonable assurance of safety and effectiveness, without the
addition of the suggested text, because it contains enough information
for someone to identify whether an OTC hearing aid may be intended for
their particular hearing impairment. Therefore, we are not revising
this final rule in the way suggested by the comment.
However, as stated above, the additional information described in
the comment may still be useful so we intend to add similar information
to FDA's website, which has pages focused on hearing aids and hearing
loss. You can access the main web page at: https://www.fda.gov/medical-devices/consumer-products/hearing-aids. You may also wish to review
information from the National Institute on Deafness and Other
Communication Disorders. You can access their web pages at: https://www.nidcd.nih.gov/health/hearing-ear-infections-deafness. These
websites provide more information for people interested in learning
about hearing aids and hearing loss.
(Comment 36) A few comments expressed concern that, without proper
warnings on the label, purchasers would not be informed on the
limitations of OTC hearing aids with regard to their degree of hearing
impairment.
(Response) FDA agrees and is finalizing the clear statement that we
proposed, with an updated, more user-friendly list of common symptoms
of mild to moderate hearing impairment. We are also finalizing the
requirement, with similarly improved language, that the labeling
describe signs of more severe impairment.
(Comment 37) A few comments expressed concern about the statement
that hearing aids will not restore normal hearing and that training and
counseling from a hearing healthcare professional may increase
satisfaction. Comments argued that these ideas are based upon current
limitations of hearing aids and recommended the statement be removed
because, they argued, future hearing aids may have the capability to
restore hearing to a normal level.
(Response) FDA is declining to remove this statement. The note
informs consumers of the limitations and benefits they should expect
from an OTC hearing aid. Since many purchasers will be selecting and
using OTC hearing aids without the involvement of a licensed person,
FDA has included statements, including the one discussed above, to help
consumers have realistic expectations about OTC hearing aids. This
helps provide reasonable assurance of safety and effectiveness.
(Comment 38) A few comments requested that labeling include a
warning of when to stop use of OTC hearings aids. The comments
expressed concerns that some hearing aid users may be unaware that they
should stop use of OTC hearing aids due to the onset of certain
conditions, for example, ear drainage, pain, and balance issues.
(Response) FDA agrees that certain conditions should suggest that
users consult with a hearing healthcare provider, but we do not agree
that the onset of such conditions necessarily indicates the user should
stop using OTC hearing aids. FDA has revised the labeling to make it
more general so that it warns users to see a doctor, preferably an ear-
nose-throat doctor, if the user experiences any of the listed problems
before or after purchase.
(Comment 39) A few comments recommended an additional warning on
the inside package labeling to alert individuals that there is
potential harm when wearing hearing aids for longer than recommended.
Comments proposed a warning to users to exercise special care in the
use of the device. It would warn against use of the hearing aid for
more than 12 hours a day, for example, and against use if the device
becomes uncomfortable, either due to the loudness of sound or the
physical fit of the device. Such proposed warnings sought to mitigate
the risk of further
[[Page 50714]]
impairment if the device was set to the maximum output level and worn
for periods of time exceeding these recommendations.
(Response) FDA is declining to implement such suggestions. OTC
hearing aids are designed to be worn all waking hours in a variety of
listening environments and situations. The labeling required in this
rule provides reasonable assurance of safety and effectiveness,
including through notices that the hearing aid sound output should be
neither uncomfortable nor painful, and that the hearing aid should not
cause pain or discomfort when inserting or placing it.
(Comment 40) A few comments expressed concern that the labeling
lacked reference to how a hearing healthcare professional can assist
and benefit a person purchasing an OTC hearing aid. Comments
recommended FDA develop labeling that includes guidance that, due to
their specialized knowledge, hearing healthcare professionals are
better at assisting in hearing tests and maximizing the benefits of a
hearing aid.
(Response) FDA declines to make this addition to the labeling. This
rule includes requiring specific language to assist consumers in
determining whether an OTC hearing aid best meets their needs and when
to consult a licensed professional. As mandated by FDARA, this rule
establishes requirements to provide reasonable assurance of safety and
effectiveness of OTC hearing aids without the involvement of a licensed
person; therefore, while FDA agrees that licensed professionals provide
valuable services, FDA will not be incorporating further requirements
to include additional information about the benefit of licensed
professionals in the labeling.
(Comment 41) FDA proposed that the outside package labeling include
a statement that the device may not be useful for more significant
hearing loss or complicated hearing needs. Some comments expressed
concern that the warning used ``significant hearing loss'' without
providing a definition of how to distinguish mild to moderate from
significant hearing loss. These comments suggested that FDA further
delineate mild to moderate from significant hearing loss, some of them
suggesting we use objective criteria rather than more-subjective
perceptual terms.
(Response) The final labeling requirements include the signs
suggestive of both perceived mild to moderate hearing impairment and
more significant hearing impairment. FDA included this information to
assist consumers in determining whether OTC hearing aids can meet their
needs. We have improved the phrasing of this information to be more
understandable to inexperienced hearing aid users, including by
removing the phrases the comments characterized as not defined well
enough. However, as discussed in the response to Comment 24, FDA is
declining to define hearing impairment in terms of objective criteria
for the reasons explained in that response. We are continuing to
delineate the different degrees of severity with perceptual terms as we
believe this will be most useful to the intended users.
(Comment 42) Comments expressed concern that the symptoms
suggesting perceived mild to moderate hearing impairment can also be
indications of more significant hearing loss.
(Response) FDA infers these comments are concerned that consumers
may mistake their degree of hearing loss due to the commonality of
symptoms. FDA disagrees. FDA has specified some listening scenarios
that represent some of the most common perceptual difficulties a user
with perceived mild to moderate hearing impairment may experience.
Although these symptoms may apply to multiple types and degrees of
impairments, they are most common to perceived mild to moderate hearing
impairment and therefore helpful to prospective users of OTC hearing
aids. Further, FDA is also requiring that the symptoms commonly
experienced by individuals with more significant impairment, with a
recommendation to consult with a hearing healthcare professional, be
included on the outside package labeling. Although FDA is finalizing
more user-friendly language, we are declining to modify the symptoms
for perceived mild to moderate hearing impairment. We believe that this
information, along with the information required in the labeling to
assist people with more severe impairment, will help prospective users
determine whether an OTC hearing aid is a good choice for them.
(Comment 43) A few comments suggested labeling requirements include
notice to individuals younger than 18 years old who are experiencing
hearing issues that they should visit a hearing healthcare provider
prior to using hearing aids due to complications that can cause
auditory impairment and developmental issues.
(Response) FDA agrees with the concerns expressed by these comments
and believes the labeling requirements address these concerns. For
example, the labeling requirements in the proposed rule, which are
being finalized here, include language that individuals under the age
of 18 should consult with a doctor and refrain from using OTC hearing
aids. It emphasizes the possible need for medical testing and the
potential for hearing impairment in younger people to affect speech and
learning.
(Comment 44) A few comments recommended that labeling include an
explanation on the differences between prescription hearing aids, OTC
hearing aids, and PSAPs to help consumers to select the appropriate
device.
(Response) FDA is declining to require in the labeling an
explanation of the differences between OTC hearing aids, prescription
hearing aids, and PSAPs. Although this information may be helpful to
know, it is not necessary for reasonable assurance of safety and
effectiveness of OTC or prescription hearing aids. The labeling
requirements for OTC hearing aids include common symptoms of those with
mild to moderate hearing impairment and symptoms of more significant
hearing loss to help consumers decide whether an OTC hearing aid is a
good choice for them. Further, as discussed elsewhere in this document,
prescription hearing aids must be sold only to or on the prescription
or other order of a licensed practitioner (see Sec. 801.109).
Therefore, a licensed practitioner will be involved in determining
whether a prescription hearing aid is appropriate for an individual
with hearing impairment. Additionally, FDA is issuing a guidance with
this final rule that will provide additional clarification of the
differences between hearing aids and PSAPs. The notification of
availability for the guidance appears elsewhere in this issue of the
Federal Register.
(Comment 45) A few comments requested that OTC hearing aid labeling
include a warning that people should not use OTC hearing aids if they
have tinnitus. Comments expressed concern that tinnitus can be an
indicator of serious medical conditions requiring proper management
from a hearing healthcare professional, and failure to seek immediate
treatment could cause further harm.
(Response) In the labeling requirements, FDA has included tinnitus
in one ear as a condition for which users should seek medical
evaluation. FDA is declining to expand upon this labeling requirement
to include tinnitus in both ears since bilateral tinnitus often occurs
in the presence of any degree of hearing loss. As such, the warning
would be overly broad if it were to include bilateral tinnitus.
[[Page 50715]]
(Comment 46) A few comments suggested modifying the proposed
language recommending users consult a hearing healthcare professional
if they remain concerned about their hearing or struggle to use the
device. The comments suggested that the labeling recommend users first
contact the manufacturer to allow them an opportunity to resolve any
issues.
(Response) FDA is declining to implement this suggestion. The
statement notifies users that dissatisfaction with the compensation for
impaired hearing may call for the attention of a hearing healthcare
professional. Although FDA sees the potential benefit in users
consulting with manufacturers to resolve certain technical or use
questions, the purpose of the note is not to assist with device
troubleshooting. Manufacturers may, however, include a troubleshooting
section (or similar section) in the user instructions and provide
suggestions for when users should consult them for technical or use
issues that would not necessarily call for the involvement of a hearing
healthcare professional.
(Comment 47) Some comments requested FDA require the labeling on
and/or inside the package of OTC hearing aids include information about
telecoils. Comments expressed concern that first-time hearing aid
purchasers will not be able to make informed decisions about telecoils
without an explanation of telecoil capabilities. Specific labeling
suggestions varied, but they included statements of whether the device
includes telecoils, explanations of what telecoils are, and the
benefits telecoils may provide.
(Response) FDA is declining this suggestion because not all OTC
hearing aids will have telecoils, and existing requirements would
apply, for example for adequate directions for use (see section
502(f)(1) of the FD&C Act and Sec. 801.5). (See also the response to
Comment 94 about requiring telecoils.) Including the information about
the feature could be confusing to consumers when the device does not
include telecoils. Conversely, if a hearing aid includes telecoils,
information about them would be necessary to provide adequate
directions for use, so the information would have to appear in the
labeling (see section 502(f)(1) of the FD&C Act and Sec. 801.5).
(Comment 48) Some comments requested that labeling for OTC hearing
aids include a questionnaire to assist consumers in deciding if OTC
hearing aids are appropriate for them. Comments recommended the
questionnaire to assist consumers in determining if they have a medical
condition that requires a visit to a hearing health care provider prior
to using OTC hearing aids.
(Response) FDA will not be implementing this suggestion. The
labeling requirements we are finalizing, including information on Red
Flag conditions and symptoms of more significant hearing loss, are
sufficiently informative to provide reasonable assurance of safety and
effectiveness without the additional time and effort necessary to
complete a questionnaire and assess the results for purposes of
deciding whether an OTC hearing aid is appropriate.
(Comment 49) A few comments expressed concern about the note
regarding what a hearing aid can do, which includes a statement that,
if a user has hearing loss in both ears, use of hearing aids for both
ears (bilateral hearing aids) may provide more benefit than just one
hearing aid. Comments suggested that this may discourage individuals
who wish to begin with only one hearing aid. Comments recommended
removing this paragraph from the note.
(Response) FDA disagrees that this statement would deter
individuals from using one hearing aid. This statement does not suggest
that individuals must use two hearing aids in all cases. This statement
in the note simply conveys that two OTC hearing aids may provide more
benefit in the case of hearing loss in both ears. Moreover, should
individuals with hearing loss in both ears start with one OTC hearing
aid and desire more benefit, this information would be useful to help
them understand how to achieve greater benefit.
(Comment 50) A few comments requested that the labeling include
guidance as to what to do when an eartip gets stuck in the ear canal.
(Response) FDA infers that the information requested by comments is
meant to assist users in determining when to consult a healthcare
professional. FDA agrees that providing guidance to users on this issue
is important. We have updated the labeling to help users decide when to
seek medical help (see new Sec. 800.30(c)(2)(iii)(C)).
3. Outside Package Labeling and Purchasing Decisions
(Comment 51) A few comments recommended a statement for individuals
with ability limitations, such as a developmental disability, similar
to statements directing people under the age of 18 to seek examination
and evaluation by hearing healthcare professionals. Commenters implied
that, just as with individuals under 18, individuals with ability
limitations may not have the same ability to determine their hearing
loss or the presence of more serious medical issues; therefore,
evaluation by a licensed professional would be necessary.
(Response) FDA is declining to implement this suggestion. The
statements addressed to those under age 18 concern hearing healthcare
needs that are specific to younger people, such as speech and learning
difficulties. Additionally, as explained in the proposal, the use of
OTC hearing aids in people younger than 18 presents risks to health
beyond those typically associated with use in older people. Whereas
hearing loss in older adults is most commonly related to noise exposure
and aging, the etiology (causes) of hearing loss in younger people is
varied and may result from conditions that warrant prompt diagnosis to
avoid serious risks to health (see 86 FR 58150 at 58158). The comments
provided no information to support that adults with ability limitations
face similar risks to those younger than 18.
Further, we have revised the labeling with more user-friendly terms
throughout. We believe the information required in the labeling,
including statements identifying Red Flag conditions and advising users
to consult with a hearing healthcare professional if they continue to
struggle with or remain concerned about their hearing, are appropriate
for adults with perceived mild-to-moderate hearing impairment. We do
not agree that revising the labeling or limiting purchases for certain
adults in the manner suggested by the comments is necessary to provide
reasonable assurance of safety and effectiveness of OTC hearing aids.
(Comment 52) A comment requested that FDA standardize the names of
hearing aid features so that interested people could compare products
more easily. In that vein, multiple comments suggested that FDA develop
a rating system to compare features. The commenter expressed that
information should be accessible to lay users and that relying on a
regulatory guidance document, should FDA issue one in the future, to
convey such information is unlikely to assist most consumers, who are
not experts in hearing aid technology. Similar comments desired a
rating system for device performance in certain conditions, for
example, live concerts.
(Response) FDA agrees that interested people should have sufficient
information to compare products as easily as possible, and we have made
various revisions in this final rule to
[[Page 50716]]
improve the usefulness of the required labeling for laypeople. We are
also finalizing a requirement for a conspicuous mark identifying the
hearing aid as OTC that we expect will help purchasers and others
distinguish product categories (see Additional Revision 2 in section
III.D.3). Further, FDA's website describes common hearing aid
technologies and features to help orient consumers with the technology
and terminology, available at: https://www.fda.gov/medical-devices/hearing-aids/types-hearing-aids. However, we are not making additional
revisions in the final rule to standardize the names of device
features.
We note that a number of regulatory requirements will nevertheless
assist consumers to compare devices and features. For example, the
applicable classification regulation for a device specifies the name of
the device type (so is standardized in that way), and the principal
display panel on the package of an OTC device must display a statement
of identity that includes the common name of the device, in bold
typeface (see Sec. 801.61). Further, the labeling must include
adequate directions for use that allow a layperson to use the device
safely and for its intended purpose(s) (see Sec. 801.5). And for OTC
hearing aids, we proposed and are finalizing a requirement under new
Sec. 800.30(c)(4) that the labeling include certain technical
specifications. Purchasers interested in the electroacoustic
performance could use this information to compare across devices.
We acknowledge that manufacturers may use proprietary names for
device features, even when other manufacturers offer a similar feature
under a different name (perhaps also proprietary). However, FDA expects
that hearing aid technology will continue to evolve and that device
features will similarly evolve, including the specific capabilities.
Precisely identifying, describing, and naming those features and ways
to compare them by regulation, even for the present, is neither
practical nor necessary. Further, individuals may have different
preferences as to which features are more valuable in a hearing aid.
For similar reasons, a rating system is neither practical nor
necessary. Even with additional standardization of terminology, the
import of each feature may still not be apparent to purchasers, and
similarly, rating systems may not reflect (rate highly) the features of
a device that a given purchaser would value. Thus, finalizing
regulatory requirements for such a system of comparison is not likely
to communicate useful information to purchasers and may hinder
innovation by codifying current characteristics of device features.
To communicate useful information, we expect that manufacturers
will describe their devices' features in ways that best appeal to the
intended users, and the labeling of a hearing aid will have to be
available to prospective users prior to purchase (see new Sec. Sec.
800.30(c)(2) and 801.422(c)(2)). Moreover, the labeling of a device
must not be false or misleading in any particular (see 21 U.S.C.
352(a)(1)). These requirements will help ensure that purchasers have
accurate information about a hearing aid and its features in a way that
allows them to compare these devices.
As for ratings for device performance in certain conditions, given
the subjective nature of user preferences, developing a useful rating
system is impracticable. We expect that purchasers will have access to
a wealth of opinions from other purchasers, product testers or
reviewers, and consumer information organizations. This will allow
purchasers to find ratings that reflect their interests more than any
possible criteria standardized by regulation. For example, a purchaser
may prefer OTC hearing aids that users rate highly for use in a
restaurant. Additionally, user preferences may change in the future, so
any rating system may become quickly outdated.
Regarding device performance more generally, as we explained in the
proposal, we are establishing electroacoustic performance requirements
for high-fidelity amplification (see 86 FR 58150 at 58163). A hearing
aid must meet these requirements to be available OTC, but the device
need not outperform them. By extension, a device need not perform
better than a high-fidelity level of amplification. Establishing a
rating system for compliant devices, that is, for those that would
already have high fidelity, would incorrectly imply some devices are
substandard. We are not finalizing requirements for describing how well
a device performs beyond the electroacoustic performance specifications
in the labeling, the performance itself being required to meet a
standard for high fidelity.
(Comment 53) A few comments recommended that information about
whether a battery was included, and what type of battery is required,
be included on the labeling. Comments recommended the inclusion of this
information so that consumers can purchase the necessary batteries at
the same time as the OTC hearing aid and adequately compare OTC hearing
aids.
(Response) We agree that it is important for manufacturers to
include information about the type, as well as the number, of
batteries, and whether batteries are included because this is
information consumers will need to use the hearing aid. Therefore, FDA
is revising the final rule to require this information on the labeling
outside the package of the hearing aid so that consumers are aware of
the battery requirements prior to, or at the time of, purchase.
(Comment 54) A few comments recommended including a description of
any smartphone compatibility requirements to operate the hearing aid on
the outside package labeling. Comments argued this would allow
consumers to determine if they have the necessary device and
programming to operate the hearing aid prior to purchase.
(Response) FDA agrees with the comments that this information is
important for consumers to know when comparing OTC hearing aids at the
retailer. Similar to the battery information discussed above,
information on the control platform is necessary for use of the hearing
aid. Therefore, FDA is revising the final rule to require that the
outside package labeling indicate whether a mobile device or other non-
included control platform is required, such as a smartphone, a remote
sold separately, or a personal computer. The labeling also will have to
indicate the type of control platform and how the hearing aid connects
to the control platform, for example, via Bluetooth and/or USB-C.
(Comment 55) A few comments suggested that the rule require a list
of other basic features of each OTC hearing aid (for example, mobile
operating system, volume controls, feedback, telecoil, or accessories)
on the outside package. Comments expressed concern that, without a list
of features, consumers may have difficulty comparing different OTC
hearing aids and make an informed decision.
(Response) FDA is declining to implement this suggestion in its
entirety. The packaging provides limited space for required labeling,
and while we have adopted some such suggestions--see the responses to
Comment 53, about batteries, and Comment 54, about smartphone
compatibility--we have not determined that the other information is
necessary on the outside package labeling to provide reasonable
assurance of safety and effectiveness. Additionally, we are finalizing
the requirements as proposed
[[Page 50717]]
that the inside package labeling, among other requirements, provide
illustration(s) of the OTC hearing aid that indicates operating
controls, user adjustments, and the battery compartment (see Sec.
800.30(c)(2)(iv)), provide information on the function of all controls
intended for user adjustment (see Sec. 800.30(c)(2)(v)), and describe
any accessory that accompanies the OTC hearing aid (see Sec.
800.30(c)(2)(vi)). As the inside package labeling must be made
available prior to purchase (see Sec. 800.30(c)(2)), consumers will be
able to access this information prior to purchase. Further, as
discussed in the response to Comment 26, any OTC hearing aid must have
labeling that bears adequate directions for use that allow a lay user
to use the device safely and for its intended purposes (see Sec.
801.5). In cases where necessary for adequate directions for use,
information on other features not specified in Sec. 800.30(c) will
have to appear in the labeling, and prospective users will have access
to the labeling prior to purchase.
(Comment 56) Some comments expressed concerns for device labeling
that states an OTC hearing aid is ``FDA approved,'' ``FDA cleared,'' or
otherwise endorsed by the FDA. The comments asserted that such labeling
indicates that: FDA has inspected an OTC device for quality and/or
compliance with applicable legal requirements, that FDA has approved
the device for use by the individual purchaser, and/or that FDA favors
the device over others without such labeling. The comments argued that
such indications are misleading for purchasers.
(Response) FDA does not endorse particular devices and
representations of such in labeling can be false or misleading. The
determination of whether ``FDA cleared,'' ``FDA approved,'' or similar
language on a device's labeling suggests FDA endorsement of the device
or is otherwise false or misleading is made on a case-by-case basis.
Clearance of a device indicates that FDA has determined the device
to be substantially equivalent to a class I or II device. It does not
in any way denote official approval of a device or in any way imply
that the device is in compliance with any other pertinent sections of
the FD&C Act (see 41 FR 37458 at 37462, September 3, 1976). Likewise, a
grant of a De Novo classification request under 21 CFR 860.260(a)(1) or
compliance with registration and listing requirements under part 807
does not denote official approval or imply compliance with other
pertinent device requirements. Any representation that creates an
impression of official approval of a device due to complying with
requirements for premarket notification or registration is misleading
and constitutes misbranding (see Sec. Sec. 807.97 and 807.39,
respectively).
The labeling of a device may be false or misleading for other
reasons too. For example, if a statement in the labeling creates an
impression that FDA officially favors one classified device over
another, it would likely be false or misleading. Or, if the labeling
uses FDA's logo, creating an impression that FDA has endorsed the
product, it would likely be false or misleading.\8\ A device would be
deemed to be misbranded under section 502(a)(1) of the FD&C Act if its
labeling included such false or misleading statements. The FD&C Act
prohibits doing or causing certain acts with respect to a misbranded
device (see, e.g., 21 U.S.C. 331(a)-(c), (k)).
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\8\ FDA's logo is not for use on private sector materials,
including device packaging. For more information, you may wish to
review FDA's logo policy, available at: https://www.fda.gov/about-fda/website-policies/fda-logo-policy.
---------------------------------------------------------------------------
(Comment 57) A comment requested clarification on the applicability
of prescription labeling requirements under new Sec. 801.422 to the
implantable components of a bone-conduction hearing aid. The comment
argued that applying the labeling requirements to the implantable
components is unnecessary because a surgeon has already decided to
implant specific components, and the labeling under new Sec. 801.422
is neither necessary nor helpful for the surgeon or the hearing aid
user. In contrast, the non-implantable components of a bone-conduction
hearing aid, such as the sound processor, are often marketed separately
and not necessarily through a physician.
(Response) FDA agrees that the labeling requirements under Sec.
801.422 are not necessary for reasonable assurance of safety and
effectiveness with respect to the implantable components of a bone-
conduction hearing aid. We have modified the classification regulation
to clarify that the labeling requirements for prescription hearing aids
apply only to the non-implantable components of a bone-conduction
hearing aid. In cases where the implantable components are not sold or
distributed with the non-implantable components, the implantable
components need not bear the labeling under new Sec. 801.422.
(Comment 58) One comment requested that FDA strike Sec.
801.422(c)(1)(ii)(A). The comment stated that the decision to offer
trial rentals or purchase options is a trade issue and does not relate
to the safety or effectiveness of the device.
(Response) FDA has decided to retain Sec. 801.422(c)(1)(ii)(A) (in
the final rule, this information is in Sec. 801.422(c)(1)(i)(C)). FDA
notes that Sec. 801.422(c)(1)(ii)(A) does not require offering a
trial-rental or purchase-option program. Instead, this provision just
requires that the outside package labeling for a prescription hearing
aid include information advising prospective users to inquire about the
availability of a trial-rental or purchase-option program.
FDA also notes that Sec. 801.422(c)(1)(ii)(A) is substantially
identical to what was already required to be included in the user
instructional brochure for a hearing aid under former Sec.
801.420(c)(3). In other words, the information required under Sec.
801.422(c)(1)(ii)(A) is not new and has been required to be in hearing
aid labeling for many years. The only differences between Sec. Sec.
801.420(c)(3) and 801.422(c)(1)(ii)(A) are: Sec. 801.422(c)(1)(ii)(A)
applies only to prescription hearing aids, Sec. 801.422(c)(1)(ii)(A)
requires that the information be provided on the outside package
labeling for a prescription hearing aid, and the required statement
under Sec. 801.422(c)(1)(ii)(A) uses language that is easier to
understand.
FDA continues to believe that this labeling requirement is
necessary to provide reasonable assurance of safety and effectiveness
of prescription hearing aids. When FDA included the requirement in
former Sec. 801.420(c)(3) to provide information in the user
instructional brochure advising prospective users to inquire about the
availability of a trial-rental or purchase-option program, FDA
acknowledged the difficulty of determining in advance whether an
individual will benefit from a hearing aid, and we noted that voluntary
trial-rental or purchase-option programs for prospective hearing aid
users were available (42 FR 9286 at 9289).
FDA believed that trial-rental or purchase-option programs, which
provide prospective hearing aid users the opportunity to wear the
selected hearing aid so that the user can make an informed judgment on
whether a benefit is obtained from the use of the hearing aid, were
important to the welfare of the hearing impaired and therefore,
required that the user instructional brochure contain information
advising prospective users to inquire about the availability of such
program (42 FR 9286 at 9289). FDA explained that this information would
help assure that the
[[Page 50718]]
selected hearing aid would be beneficial and would encourage hearing
aid use among those prospective users who lack the motivation to try a
hearing aid because of the fear that they will spend a great deal of
money with no guarantee of benefit (42 FR 9286 at 9289). FDA believes
that the reasons for requiring this information in labeling continue to
apply for prescription hearing aids, which are typically sold through
licensed hearing aid dispensers, many of whom offer such programs.
(Additional Revision 2) In response to various concerns evident in
the comments, we are including in this final rule a requirement that
the principal display panel of the outside package labeling of an OTC
hearing aid bear the conspicuous marks, ``OTC'' and ``hearing aid.''
FDA intends these marks to clarify for purchasers and others, including
retailers and State agencies, whether a product is a hearing aid
(regulated as a device), and whether it is available OTC. (See also the
response to Comment 18 discussing hearing aid terminology.) However,
these marks do not in any way denote official approval of the device,
and any representation that creates an impression of official approval
because of complying with these marking requirements or with the OTC
Hearing Aid Controls would be considered false or misleading and
constitute misbranding. (See also the response to Comment 56 regarding
other false or misleading statements.) The marking is necessary for
reasonable assurance of safety and effectiveness of OTC hearing aids
because it provides assurances that non-OTC hearing aids or non-devices
will not be confused for OTC hearing aids.
The marks must have the same prominence as required under Sec.
801.61(c) for the device's statement of identity, and a manufacturer
may satisfy this new marking requirement if the statement of the
device's common name includes both ``OTC'' and ``hearing aid.'' For
example, a manufacturer may label its product as a ``Self-Fitting OTC
Hearing Aid'' (assuming the device's common name is ``self-fitting
hearing aid''). Such a device would meet this new marking requirement
as well as the requirement for the common name in the statement of
identity. Alternatively, the manufacturer may, for example, label its
product without including the marks in the common name of the device,
perhaps by placing ``OTC'' in a corner of the principal display panel
with the required prominence (assuming the device's common name
includes ``hearing aid''). Formatting the marks, for example, by
outlining them with a box, would be permissible provided the formatting
does not cause the marks to lack the required prominence (see 21 CFR
801.15(a)(6)).
4. Labeling Inside the Package and Technical Matters
(Comment 59) A few comments requested that the frequency response
and ANSI S3.22 specifications of OTC hearing aids be included in the
user manual.
(Response) FDA infers this request is to assist in selecting an OTC
hearing aid with optimal performance. We are not requiring the
requested information in OTC hearing aid labeling because, as we
explained in the proposal, this information is highly technical and
generally not useful to the lay user (see 86 FR 58150 at 58163).
However, we are finalizing the proposed requirement that OTC hearing
aid labeling include key electroacoustic performance specifications
that are more likely to assist prospective lay users in comparing and
selecting the devices, including the values for maximum output, full-on
gain, total harmonic distortion, self-generated noise, latency, and
upper and lower cutoff frequencies for the acoustic bandwidth.
(Comment 60) A few comments expressed concern that requiring
summaries of clinical studies conducted by or for the manufacturer on
the inside labeling is not practical. Comments suggested that providing
a link to an online library of the clinical studies and a summary of
each study on the manufacturer's website would suffice.
(Response) FDA disagrees that providing summaries of clinical
studies in the labeling inside the package is impractical. While we
understand that fully appreciating the outcomes of a study can entail a
lengthy technical document, presenting the most important findings
regarding the performance of the OTC hearing aid, in a user-friendly
format, need not take significant space in the labeling. We are
finalizing the requirement as proposed.
(Comment 61) A few comments requested that the labeling include
information on how the OTC hearing aid can be fixed or repaired.
Comments requested that the information include whether a local hearing
healthcare professional can repair the device or if it needs to be sent
to the manufacturer. Comments argued this would allow prospective users
to make an informed decision when purchasing their devices.
(Response) FDA agrees that manufacturers should provide users with
information on how to have their hearing aid repaired because this
information may be difficult for users to obtain on their own. The
inside package labeling requirements now include information on how and
where to obtain repair service or replacements, with at least one
specific address where the user can go or send the OTC hearing aid to
obtain such repair service or replacements.
(Comment 62) A few comments expressed concern that estimating the
expected battery life will be difficult for manufacturers due to
inconsistencies between batteries and use conditions. Comments proposed
removing this requirement from the labeling inside the package.
(Response) FDA recognizes that battery performance can vary but
will retain this requirement in the final rule because this information
will help prospective purchasers determine whether a hearing aid will
be suitable for their circumstances. Recognizing that performance can
vary from device to device, we did not propose, and are not requiring,
a specific method of estimating the battery life. However,
manufacturers may want to review Clause 4.7 (Battery Life) of ANSI/CTA-
2051:2017, which currently provides an acceptable method to estimate
the battery life (Ref. 8).
(Comment 63) A comment proposed a requirement for OTC hearing aid
labeling to include information about the transport methods for
configuration information and other data to and from the OTC hearing
aid with all points along the supply chain.
(Response) FDA is not adopting this proposal because such
information is focused on the electronic transfer of non-diagnostic
data and is not generally necessary for reasonable assurance of safety
and effectiveness of all OTC hearing aids. We note, however, that
should States establish or continue in effect requirements to disclose
such information, and the requirements are not specifically applicable
to hearing products, section 709(b)(4) of FDARA likely would not
preempt them. However, FDA is not opining on whether such disclosure
requirements likely would or would not be preempted under section
521(a) of the FD&C Act. (See also the response to Comment 115
concerning the collection of personal information as part of a sale of
an OTC hearing aid.)
(Comment 64) A comment requested that FDA require labeling that
specifies the latency of any wireless streaming technologies the OTC
hearing aid uses.
(Response) In certain circumstances, latency information in the
labeling may be necessary under existing requirements. For example, if
the information is necessary to provide adequate directions for use or
necessary
[[Page 50719]]
for practitioners licensed by law to use the device safely and for its
intended purpose(s), then the latency information would have to appear
in the device labeling (see Sec. Sec. 801.5 and 801.109(c),
respectively).
However, as a general matter for hearing aids that incorporate
wireless streaming technology, FDA has determined that stating the
streaming latency is not necessary to provide reasonable assurance of
safety and effectiveness. Additionally, a variety of factors can affect
wireless streaming latency, including nearby radio interference,
distance between the transmitter and receiver, and the presence of
materials that absorb certain radiofrequencies. As such, a standardized
wireless streaming latency value may not reflect a particular device's
design or the environment in which the user wears the hearing aid; and
thus, FDA is not adding a requirement to include wireless streaming
latency information for all OTC hearing aids in this rule. We note that
FDA is finalizing requirements for OTC hearing aid labeling to include
manufacturer contact information. If users or prospective users are
interested in the streaming latency specifically, they will be able to
contact the manufacturer.
(Comment 65) A few comments requested a labeling requirement
describing the fitting range across different frequencies (500, 1000,
2000, and 4000 Hertz) to help consumers determine the suitability of
different OTC hearing aids to meet their needs.
(Response) FDA understands that traditionally, hearing aids are
designed and marketed with a specific fitting range in mind, and
manufacturers may maintain this practice. However, OTC hearing aids are
intended to be available without the involvement of a licensed person
(see 21 U.S.C. 360j(q)(1)(A)(v)). As such, FDA is not using audiometry-
defined thresholds or ranges of hearing loss in the final rule.
Instead, FDA is using descriptions of common symptoms of mild to
moderate hearing impairment in the labeling. As such, describing the
fitting ranges across different frequency bands is not necessary for
reasonable assurance of safety and effectiveness of OTC hearing aids.
However, manufacturers may choose to include this information in device
labeling, and prospective users will have access to the manufacturer's
contact information prior to purchase should they desire to inquire
about the fitting ranges.
5. Adverse Event Reporting
(Comment 66) The proposed labeling included instructions on
reporting adverse events through the MedWatch portal, https://www.fda.gov/Safety/Medwatch, or by phone, 1-800-FDA-1088. A few
comments requested that email and mailing options also be provided for
adverse event reporting. Comments further recommended that FDA provide
a receipt of the complaint to individuals.
(Response) We are declining to include a mailing address in the
labeling because submissions by mail should be on a MedWatch form, for
example, the Consumer Voluntary Reporting Form (FDA 3500B), which
contains the address along with additional instructions. Reference to
just the address in hearing aid labeling may result in reports
submitted in an unexpected manner and format, potentially causing
confusion, incomplete reports, and significant delays in processing
them. However, in addition to reporting events through the MedWatch
portal and 1-800-FDA-1088, consumers can submit their adverse event
reporting form to FDA by fax or the mailing address according to the
instructions on the form. Submitters will receive a reply from FDA
after we receive their report. Email is not currently an alternative to
the MedWatch online submission system.
(Comment 67) A few comments recommended that in addition to
labeling information on reporting adverse events to FDA, contact
information for manufacturers should be required so that manufacturers
are provided the opportunity to review adverse events. Comments implied
that providing manufacturers with awareness about adverse events and
opportunity to address them would be beneficial to consumers.
(Response) To help facilitate communications between users and
manufacturers, FDA has added the manufacturer's email and mailing
address to the labeling requirements (see final Sec.
800.30(c)(1)(i)(E)). Should users wish to report adverse events to the
manufacturer, they may use this information to do so. Manufacturers may
also include instructions in the labeling, that do not conflict with
the labeling requirements, on how to directly report adverse events to
them.
(Comment 68) FDA included in the proposed labeling examples of
adverse events to be reported to FDA: irritation of the ear canal or
outer ear skin, injury from the device (like cuts or scratches, or
burns from an overheated battery), pieces of the device getting lodged
in the ear canal, and sudden increased severity in hearing loss with
the device. Some commenters suggested limiting the list to more-serious
conditions to avoid the adverse reporting system being overwhelmed by
reports of minor adverse events. Commenters expressed concern that if
the labeling were finalized as proposed, more serious adverse events
may get lost in the volume of what the commenters see as minor.
Commenters recommended adverse event reporting be limited to
significant injury and/or death.
(Response) FDA is declining to limit the examples of adverse
events, or the reporting of adverse events, to significant injury and/
or death. FDA is interested in receiving information on all adverse
events to have a better understanding of OTC hearing aid product safety
and performance. Additionally, under section 709(d) of FDARA, FDA is
required to submit a report to Congress ``analyzing any adverse events
related to over-the-counter hearing aids.'' FDA is prepared to review
adverse event reports and has experience in sorting through adverse
event reporting data to identify safety signals and trends.
(Comment 69) Comments requested that users of prescription hearing
aids be able to report adverse events to FDA similar to how OTC hearing
aid users can report through the MedWatch portal at https://www.fda.gov/Safety/Medwatch, or by phone, 1-800-FDA-1088.
(Response) We agree that prescription hearing aid users should also
report adverse events to FDA. We proposed and are finalizing the same
note for prescription hearing aids to notify users of how to report
adverse events to FDA.
6. Miscellaneous Labeling Considerations
(Comment 70) Some comments recommended that restrictions on the use
of OTC hearing aids by individuals under the age of 18 be removed.
Comments expressed the need for cost effective hearing aids for
individuals under 18. Additionally, comments asserted that individuals
under 18 are increasingly suffering from hearing loss as a result of
exposure to loud sounds, which they argued is hearing loss that can be
addressed by OTC hearing aids.
(Response) FDA is declining to allow the sale of OTC hearing aids
to individuals under the age of 18. This condition for sale is
consistent with section 709(b)(2)(C) of FDARA and section
520(q)(1)(A)(ii) of the FD&C Act, which establish that OTC hearing aids
are only intended for people aged 18 and older. The use of OTC hearing
aids
[[Page 50720]]
in people younger than 18 presents risks to health beyond those
typically associated with use in older people. While FDA appreciates
the need for cost effective hearing aids for individuals under the age
of 18, the sale of OTC hearing aids will be limited to individuals who
are age 18 and older.
(Comment 71) A few comments expressed concern that the manufacturer
contact information that FDA proposed to include in the labeling of OTC
hearing aids is limiting because the only alternative to a website
address was a telephone number. Comments argued that many individuals
with hearing loss do not prefer to communicate using the telephone and
recommended the inclusion of the manufacturer's email and mailing
address on labeling to provide greater access to users.
(Response) FDA agrees that providing additional ways for users to
communicate with manufacturers will allow for users to resolve issues
with their hearing aids more easily. The labeling requirements have
been updated to include the manufacturer's mailing address and email
address.
(Comment 72) A few comments noted that hearing aids are physically
small and do not have room for a serial number on them. Comments
recommended that the serial number be located on an accompanying item,
such as on the storage case or registration card.
(Response) FDA is declining to implement this suggestion.
Manufacturers have been complying with this long-standing requirement
for labeling under Sec. 801.420, which we are revising and renumbering
as Sec. 801.422, and marking the serial number on the device itself
(since 1977). Additionally, because accompanying items can be
misplaced, marking the device itself is essential to the utility of the
serial number.
(Additional Revision 3) As noted in the response to Comment 8, we
are finalizing labeling requirements for hearing aid software. We
expect much of the labeling to be electronic in nature, for example,
the graphic and printed matter that appear on a download web page or in
electronic display ``cards'' or dialogs in the software's user
interface. As such, electronic labeling may have a transitory nature,
and we are specifying the occasion and persistence of presentation. For
example, we are requiring that the labeling present a warning against
use in people younger than 18. In this example, the electronic
labeling, perhaps appearing in a modal dialog, need not appear at all
times. Rather, we are requiring that the labeling present the warning
to the user prior to first use of the software and persist until the
user acknowledges it. We are further requiring that the software
provide access to all of its labeling for later review, for example,
through a Help menu selection.
We intend the software device labeling requirements to correspond
with the labeling requirements we proposed for packaged hearing aids to
the greatest extent possible. As such, we are requiring that the
software device labeling present certain information prior to first use
or obtaining payment information for the software (not necessarily the
hearing aid or amplification platform), reflective of the nature of the
information we are requiring on the packaging, that is, information the
prospective user should know prior to purchase, if a purchase is
involved. Some labeling is required prior to first use, but it could
appear after purchase of the software, if a purchase is involved. Other
labeling is required to be accessible in the software, but it need not
be presented at any particular time.
We recognize that some of the information required in the labeling
under final Sec. 800.30(c)(1) through (4) may not apply to software.
For example, specific instructions for cleaning and disinfection likely
would not apply to stand-alone software (see final Sec.
800.30(c)(2)(vii)(D)). As another example, an illustration of the
battery compartment likely would not apply (see final Sec.
800.30(c)(2)(iv)). To address this, we made it clear that certain
information is required to the extent applicable. Thus, in the first
example, the software device labeling need not include instructions for
cleaning and disinfection if that information is not applicable. In the
second example, the software device labeling must include an
illustration(s), but not necessarily of the battery compartment if not
applicable. Further, in that example, a video would be an adaptation of
and suffice for an illustration(s). Although software may not have a
principal display panel like a packaged hearing aid, a software-loading
or Home screen could serve a similar function to provide the
information required under Sec. 800.30(c)(1)(iii).
We have also included requirements for the software device labeling
to disclose compatibility requirements as well as any fees or payments.
Disclosure of compatibility requirements is necessary for reasonable
assurance of safety and effectiveness because this information
describes some of the necessary conditions under which the software
device will be usable and thus safe and effective. The disclosures of
any fees or payments are similarly necessary because they describe
necessary conditions under which the software or additional features
will start, continue, and/or cease to operate safely and effectively.
The software labeling requirements we are finalizing under new
Sec. 800.30(c)(5) are in addition to any other applicable requirement,
including special controls. For example, 21 CFR 801.50, regarding
labeling requirements for stand-alone software, would still apply to
the software when appropriate under that regulation. As another
example, the general requirements for adequate directions for use (see
section 502(f)(1) of the FD&C Act and Sec. 801.5) would also apply,
unless the software device is exempt under Sec. 801.109.
We are adding similar software device labeling requirements in
Sec. 801.422.
E. Output Limits (Sec. 800.30(d))
Generally, comments on the output limits for OTC hearing aids
either agreed that FDA's proposed limits were appropriate or comments
proposed lower limits. Several comments recommended output limits that
depend on device design, for example volume control, compression, or a
limit on gain. FDA received many comments on this subject, some of
which included references to published scientific literature, consensus
standards, stakeholder position papers, and public health guidelines.
For the following reasons, we are finalizing lower output limits than
we proposed--111 and 117 dB SPL, which are multiples of 3-dB reductions
from the proposal--but we are not including a separate gain limit.
1. Finalizing Lower Output Limits
After further considering the potential risk of worsening users'
hearing impairments as discussed below, as well as the literature
submitted to us in the comments (e.g., Refs. 10 and 11), we have
decided to finalize lower output limits than we proposed. We are
retaining the conditional structure of the output limits, with the
higher output permitted for devices with activated input-controlled
compression. (See the response to Comment 87 about requiring a user-
adjustable volume control for all OTC hearing aids.) We are also
retaining the limits expressed as Output Sound Pressure Level 90
(OSPL90) values rather than A-weighted values as suggested by some
comments. OSPL90 values are more common expressions of hearing aid
outputs, and they are consistent with the consensus standards we are
adopting, which refer to OSPL90 values.
[[Page 50721]]
Comments suggested a variety of lower limits, but we are adopting a
general limit of 111 dB SPL, which is sufficient to mitigate the
greater risk potential from both acute high-output-levels and
cumulative exposure that we identified after further consideration. We
are correspondingly finalizing the higher conditional limit of 117 dB
SPL for devices with activated input-controlled compression.
Many commenters suggested an output limit of 110 dB SPL and
considered this output limit sufficient to address even moderate
impairment, as each commenter defined the term ``moderate.'' However,
as discussed further below, we have applied an equal-energy principle
and used a 3-dB exchange rate in revising the general output limit to
111 dB SPL. We do not believe that an output limit of 110 dB SPL would
provide any meaningful difference with regard to safety.
The output limits that we are finalizing balance safety and
effectiveness without unduly sacrificing either. We are not adopting
the even lower limits suggested in some comments because these lower
limits would reduce device effectiveness for people with perceived mild
to moderate hearing impairment to such a degree that the limits would
exclude some intended users from obtaining sufficient benefit of OTC
hearing aids. At the same time, progressively lower output limits yield
diminishing returns in terms of safety. Thus, lowering the output limit
even further as suggested in some comments would begin excluding
intended users without achieving meaningful improvements in safety for
them. As a result, lowering the output limits even further as suggested
in some comments would not provide reasonable assurance of
effectiveness for people with perceived mild to moderate hearing
impairment, and thus would not be ``appropriate'' for OTC hearing aids
per section 709(b)(2)(B) of FDARA.
The reduction in effectiveness and benefit would result primarily
because, with even lower output limits, the hearing aid would no longer
have a sufficient dynamic range (``headroom'') for high-fidelity
amplification. The hearing aid could then apply compression and/or
other output limiting measures more often or to a greater degree,
resulting in perceptibly lower-fidelity (less effective) amplification.
In such circumstances, OTC hearing aids would have significantly
reduced effectiveness for the intended users, sometimes even in
normally non-hazardous environments. This reduction in effectiveness
would be increasingly noticeable for intended users as the device
output is reduced.
By way of comparison, a comment urging FDA to adopt an output limit
of 102 dB SPL also urged FDA to limit the intended users of OTC hearing
aids to people with mild impairment rather than mild to moderate
impairment. As we explain in the response to Comment 10, we are not so
limiting the OTC category, and an output limit that low would not
provide reasonable assurance of safety and effectiveness in addressing
perceived mild to moderate hearing impairment. As provided in section
520(q)(1)(A)(ii) of the FD&C Act, OTC hearing aids are ``intended to be
used by adults age 18 and older to compensate for perceived mild to
moderate hearing impairment.''
Moreover, many comments urging FDA to adopt lower limits than the
ones we are finalizing referred to material that stated output levels
in root mean square (RMS) terms. The limits we are finalizing are
expressed differently--expressed in terms of maximum peak values
(implicit in the measurement of OSPL90 values). To derive a peak value
based on an RMS level, one would increase the RMS level by an amount
that represents the ``crest factor'' of the output. Thus, except in one
circumstance that is not applicable to the materials submitted to us,
RMS values are lower than peak values for the purposes of considering
the sound output of hearing aids, and comparisons between RMS and peak
values need to take this difference into account.\9\
---------------------------------------------------------------------------
\9\ For square wave signals, the peak and RMS values would be
the same (a 0-dB difference). However, for the purposes of
describing hearing aid performance, a crest factor would be an
important element for considering limits as RMS values, for example,
to ensure a limit expressed as an RMS value allowed for effective
amplification of speech. Crest factors for speech are often 12-17
dB, with 15 dB being a value frequently cited in comments.
---------------------------------------------------------------------------
As noted, we are also finalizing a lower limit for OTC hearing aids
with input-controlled compression activated. This value, 117 dB SPL, is
intended to maximize the available headroom for OTC hearing aids while
still providing reasonable assurance of safety and effectiveness. As we
explained in the proposal, input-controlled compression is an automatic
function that dynamically reduces the device's output and helps prevent
the device from continuously performing at its output limit (see 86 FR
58150 at 58161-58162). In these ways, the use of input-controlled
compression adequately addresses the safety concerns that the increased
output can raise. We explain our reasons for finalizing lower output
limits in more detail below.
We wish to emphasize that, in finalizing lower output limits, we do
not intend to reduce the number of intended users for whom the use of
OTC hearing aids is safe and effective (in comparison to the proposed
limits). Rather, we are lowering final limits to allow sufficient
headroom for the same intended users, albeit less headroom than we
proposed. As stated above, the output limits that we are finalizing are
intended to balance safety and effectiveness without unduly sacrificing
either.
In response to comments, we are also revising the final regulation
to permit the use of alternative acoustic couplers when a 2-cubic
centimeter (cm\3\) coupler is not compatible with the device design.
See the response to Comment 81 for more on this topic.
Additionally, we are slightly modifying the phrasing of the
regulation to clarify that the device may reach the higher limit only
while the input-controlled compression is activated. For example, if a
user were to deactivate the feature, the device must not exceed the
general output limit of 111 dB SPL while the feature is deactivated.
2. Considerations for Appropriateness of Output Limits
In deciding to finalize lower output limits, FDA is primarily
considering output limits that will provide reasonable assurance of
safety and effectiveness and are ``appropriate'' for OTC hearing aids
as section 709(b)(2)(B) of FDARA uses the term. To determine such
limits, we are balancing considerations of safety and effectiveness for
all intended users of these devices to both protect and promote the
public health. As we explained in the proposed rule, too high of an
output can be unsafe (see 86 FR 58150 at 58161). However, too low of an
output reduces device effectiveness and can lead to poor device
performance, and ultimately, can reduce satisfaction and use (see 86 FR
58150 at 58161).
Many comments described the communication needs of hearing aid
users and how those interests relate to the output limits and the
purposes of establishing the OTC category of hearing aids. FDA agrees
that those interests are relevant to safety and effectiveness as well
as what would be appropriate. However, balancing the various
considerations related to safety and effectiveness is complex and
involves the application of scientific judgment. Thus, while FDA agrees
with the many thoughtful comments that several factors, discussed
further in this section, affect the determination of appropriate output
limits, we do not always agree
[[Page 50722]]
with the determination reached by commenters.
One of the purposes of this rulemaking is to address a widespread
public health need stemming from relatively low adoption and use of
hearing aids by people who could benefit from them. More specifically,
an underlying goal of this rulemaking is broadening access to these
devices, without the involvement of a licensed person, to compensate
for perceived mild to moderate hearing impairment in adults. (See the
responses to Comments 10-12 for more about the scope of this
rulemaking.) FDA is mindful of the need to establish or adopt output
limits that would provide sufficient amplification to meet the user's
listening needs and thereby bolster user satisfaction, adoption, and
use. Moreover, OTC hearing aids need a sufficient output, maximizing
the available dynamic range (the headroom), to meet the hearing needs
of the breadth of the intended population of adults with perceived mild
to moderate hearing impairment. Therefore, the output limits must not
be too low.
The appropriateness of output limits for OTC hearing aids should
also account for circumstances in which users must determine for
themselves when amplification may be excessive and then potentially
take action to mitigate or avoid the situation, without the involvement
of a licensed person for training or intervention. We are aware that
some users of hearing aids who have perceived mild to moderate
impairment may have difficulties with such tasks. For example, they may
have reduced dexterity or may have difficulty judging their listening
environments. Thus, we are also mindful of the need to establish or
adopt output limits that provide for reasonable assurance of safety and
effectiveness for such users and others. Therefore, the output limits
must not be too high. (See also the response to Comment 100 regarding
the use of consensus standards.)
FDA has considered quantitative information to inform our
consideration of safety and effectiveness. In the proposed rule, we
referred to a national workplace safety guideline, ``Occupational Noise
Exposure,'' developed by the National Institute for Occupational Safety
and Health (NIOSH) (see 86 FR 58150 at 58161-62) (Ref. 9). That
guideline, which we will refer to as NIOSH-98, defines, among other
subjects, hazardous levels of sound exposure in relation to the
duration of exposure. It uses as its basis 85 dBA (A-weighted decibels)
over 8 hours (as in, a generic workday) as the maximum non-hazardous
exposure level (see paragraph 1.1 of NIOSH-98). Roughly speaking, the
difference between A-weighted decibels and decibels of sound pressure
level, for present purposes, is about 5 dB. As such, 120 dB SPL, or
about 115 dBA, of exposure over 28 seconds would be equivalent to a
full workday's allowable exposure for purposes of occupational safety
(see table 1-1 of NIOSH-98). To address different levels of exposure
besides 85 dBA, NIOSH-98 uses a 3-dB exchange rate (or equal-energy
rule), meaning that the allowable time before the exposure is
considered hazardous halves for every 3-dB increase (see paragraph
1.1.2 of NIOSH-98). In other words, for louder exposures, NIOSH-98
indicates less allowable time than 8 hours and vice versa for lower
exposures.
We have applied an equal-energy principle and used a 3-dB exchange
rate as a basis for revising the output limits. This interval, rather
than another amount, more clearly reflects our consideration of non-
hazardous outputs and the differing output levels. Thus, 117 dB SPL,
which is 3 dB less than proposed, represents half the output power of
the proposal or twice the time to achieve the same cumulative exposure
(when the hearing aid is outputting at the limit). This translates to a
lower risk of impairment from using OTC hearing aids. However, half the
allowable power does not mean the output will sound ``half as loud.''
As such, not only does 117 dB SPL translate to a lower risk, it also
does not unduly sacrifice effectiveness.
For the purpose of illustration, you might think of a person as
having a ``budget'' of allowable sound exposure from a hearing aid to
avoid further hearing impairment. The rate at which the person goes
through the budget depends on the output level, and higher outputs
(which have higher power) will use up the budget faster than lower
outputs. In other words, because outputs at 117 dB SPL are half the
power of those at 120 dB SPL, 117 dB SPL will use up the sound budget
more slowly. If a hearing aid user encounters a sound at 117 dB SPL
while using hearing aids, the user will thus have more of the budget
left over to continue wearing the hearing aid for the rest of the day
(without over-exposure) than if the loud sound were at 120 dB SPL.
Note, however, that this analogy is merely an illustration of some
concepts of cumulative exposure. Hearing healthcare professionals use
more technical and precise concepts to describe the effects of sound
exposure on hearing abilities.
FDA notes that nothing in this rulemaking is intended to interpret
the application of NIOSH-98 for purposes of occupational exposure.
Rather, we are considering the effects of cumulative and ongoing
exposure in relation to equivalent peak output levels for the purposes
of this rulemaking. Conversely, we wish to clarify that referring to
NIOSH-98 does not mean that hearing aids should offer an output
comparable to occupational noise exposure. (The sound output of a
hearing aid is unlikely to reach its output limit regularly.)
Nonetheless, NIOSH-98 provides a well-reasoned quantitative approach to
the effects of sound exposure on people's hearing.
While many comments agreed that FDA's proposed output limits
provided an adequate safety margin, other comments disagreed and called
our attention to scenarios in which sound exposure at a relatively high
level might be followed by continuing exposure at a relatively modest
level. In certain circumstances, the equal-energy principle would imply
that the relatively modest exposure could nevertheless be hazardous. In
the proposed rule, we used the 3-dB exchange rate to compare the
presumable reaction times between 120 dB SPL and 115 dB SPL, explaining
that the latter offers about triple the time, an additional 61 seconds
(approximately), given the 5-dB difference (see 86 FR 58150 at 58161).
This does not imply that a continuous sound output of 115 dB SPL is
safe for an extended period of use of an OTC hearing aid. This also
does not imply that the user has approximately 89 seconds to intervene
(for example, to remove the OTC hearing aid). Experiencing these output
levels for long-enough periods of time could place the user at greater
risk for further hearing impairment even though the user might judge
the follow-on exposures to be modest or normal.
We acknowledge that the statement in ANSI/CTA-2051:2017 that 115
dBA (about 120 dB SPL) is an acceptable listening level for up to 30
seconds might imply that repeated exposures to 115 dBA (about 120 dB
SPL) over the course of a day's use of a hearing aid are necessarily
acceptable as long as the exposures are shorter than 30 seconds. (Note
that a day's use of a hearing aid may be longer or shorter than the
generic 8-hour workday that NIOSH-98 uses.) Further, we recognize that
referring to the full time as a safety margin did not adequately
account for exposure to other sounds throughout the day because using
the entire 28-second interval would equate to a day's worth of
allowable cumulative exposure. The
[[Page 50723]]
28-second interval assumes no other sound exposure during that 8-hour
timeframe rather than continuing use (and exposure) at a low-enough
level. In consideration of the comments, especially those calling our
attention to possible scenarios leading to excess cumulative exposure,
we have determined we should reduce the risks of cumulative exposure
and do so by finalizing lower output limits than proposed.
Nevertheless, FDA does not expect OTC hearing aids to perform at or
near their maximum output capabilities for extended periods of time
during the day, if at all. As such, neither our reference to NIOSH-98
nor to ANSI/CTA-2051:2017 should be read to imply that constant outputs
at or near 115 dB SPL (about 110 dBA) are necessarily safe. Instead,
the limits we are finalizing are meant to be high enough to allow
sufficient headroom for high-fidelity amplification for people with
perceived mild to moderate hearing impairment, including amplification
of occasional peaks necessary to reproduce certain kinds of higher
intensity, but infrequent, sounds (see 86 FR 58150 at 58161-62).\10\
However, a device's design or software may have sufficient headroom
without reaching the maximum allowable output. We intend these output
limits to facilitate wide adoption of hearing aids and design
flexibility without being unnecessarily prescriptive.
---------------------------------------------------------------------------
\10\ The maximum output for a person with greater hearing
impairment is likely to be higher than for a person with less
impairment; however, this general rule is subject to considerable
individual variability.
---------------------------------------------------------------------------
Some comments recommended that FDA adopt a requirement for
dosimetry, in essence applying similar principles as those described in
NIOSH-98. That is, they suggested that FDA require that OTC hearing
aids be able to measure the weekly sound exposure from the use of the
device. Instead of limiting peak output, the devices could then limit
exposure to a safe cumulative dose. While this approach may be one way
to limit exposure, insufficient scientific data exist regarding
cumulative exposure with the use of hearing aids by people with
perceived mild to moderate hearing impairment. Moreover, as we noted
above, this rulemaking and NIOSH-98 contemplate very different
contexts, so the quantitative information cannot be directly applied to
determining cumulative output limits appropriate for OTC hearing aids.
In sum, FDA believes that establishing a dosimetry-based limit for
regulatory purposes would be scientifically premature at this time.
Indeed, quantitative analyses of safe maximum output limits are
generally difficult to apply because the data do not necessarily
reflect regulatory considerations. For example, they do not fully
reflect the intended users, specifically users with perceived mild to
moderate hearing impairment, or other considerations for reasonable
assurance of safety and effectiveness of OTC hearing aids. Some sources
use audiometric threshold-based analyses to quantitatively predict safe
maximum output limits (e.g., Ref. 10). However, such analyses use
criteria that FDA is not adopting as they have the effect of excluding
some people for whom OTC hearing aids would be appropriate. Other
references use threshold-based analyses for the maximum output for a
hearing aid that is programmed using existing professional fitting
formulas, applied to a database of audiograms (e.g., Ref. 11). These
results, however, do not fully reflect the intended users of OTC
hearing aids, and interpreting the results often involves the
application of criteria that FDA is not adopting, for example, the
choice and application of threshold-based hearing loss categories.
In either case, these findings are limited for identifying
appropriate output limits for OTC hearing aids because this rulemaking
is intended to address perceived, not audiometrically quantified,
impairment. (See also the response to Comment 24 regarding measurements
of hearing loss and incorporating numerical thresholds into this
rulemaking.) Moreover, different commenters interpreted the same
references differently, demonstrating that even quantitative analyses
leave much to interpretation. Well-reasoned, scientific views still
exhibited significant diversity. The analyses are instructive, and we
have updated our risk assessment based in part on them, but they cannot
definitively settle the regulatory questions of this rulemaking. Hence,
although we are finalizing lower output limits based on the available
information, we are establishing the limits at 111 and 117 dB SPL
(peak, not RMS, values) rather than the even lower levels found or
suggested in some of the references submitted to us.
Other comments recommended FDA adopt international standards
developed jointly by the WHO and the International Telecommunication
Union (ITU). These comments identified ITU-T H.870 (2018), ``Guidelines
for safe listening devices/systems,'' and ITU-T H.871 (2019), ``Safe
listening guidelines for personal sound amplifiers.'' However, the
guidelines refer to a WHO-derived standard value for the cumulative
sound exposure for non-hearing-impaired adults. In other words, they
use a dosimetry-based method, which we do not believe is a suitable
basis to establish an appropriate limit, as explained above.
The guidelines do equate this to an output value of 80 dBA for 40
hours per week. However, the rationale underlying the guidelines relies
on WHO thresholds and citations to literature that, as explained, FDA
is not adopting and does not consider definitive (see the response to
Comment 24 about the WHO hearing loss thresholds). Further, as even
ITU-T H.871 (2019) explains, Ref. 10 can be read to suggest 90 dB SPL
RMS as the maximum sound output for persons with normal hearing (see
Appendix II of ITU-T H.871 (2019)). Such maximum sound output
recommendations for normal-hearing listeners cannot be used to derive
maximum output limits for a hearing aid to compensate for perceived
mild to moderate hearing impairment. Thus, FDA is declining to adopt
this cumulative exposure limit or the equivalent peak output value.
The lack of sufficient data to establish regulatory limits based on
dosimetry does not, however, mean that dosimetry is not a useful
feature. Manufacturers that wish to include dosimetry-based features in
OTC hearing aids may do so.
Ultimately, as stated previously the output limits that we are
finalizing reflect a balancing of safety and effectiveness. By lowering
the output limit 3 dB SPL from the proposed rule, these output limits
result in a meaningfully lower risk to the intended users, without
unduly sacrificing effectiveness.
3. Applying Analyses to Real-World Use of Hearing Aids
As we explain in the responses to Comments 11 and 24, the
perception of hearing impairment is conceptually integral to
establishing the OTC category of hearing aids, and the application of
audiometric thresholds to make regulatory decisions is inconsistent
with how the hearing loss categories themselves were formulated.
Moreover, audiometric threshold ranges or databases of audiograms do
not necessarily reflect the needs and wants of the intended users of
OTC hearing aids in a precise way. As such, while quantitative analyses
provide useful information, including data on exposure versus stability
of hearing impairment, the conclusions have inherent limitations that
militate against adopting them wholesale for the regulatory purposes of
this rulemaking.
FDA also considered how hearing health care providers fit hearing
aids in
[[Page 50724]]
a clinical environment. Ordinarily, a fitting algorithm determines the
necessary amplification, including the effective output limit of the
device for a given user. The provider would then make further,
iterative adjustments in consultation with the hearing aid user. These
processes effectively guarantee that the device's output will rarely
reach the device's maximum capability, if ever.
However, OTC hearing aids may not have features that prevent the
user from continuous access to the device's maximum output. Some
comments conveyed concerns that users, without the aid of professional
judgment, would want to use unnecessarily high amplification on a
continual basis; they would tend to prefer higher outputs than a
hearing healthcare professional would set. In a worst-case example, the
volume control and other features could cause maximum device
amplification in a loud environment, and the user does not take action
to mitigate the effects. In such a worst-case scenario, the user could
suffer further impairment. Although these comments used anecdotes or
more general concerns based on professional experience to support their
views, we recognize that hearing healthcare providers sometimes
recommend lower outputs than hearing aid users might initially prefer.
Thus, while we would expect that a device would seldom perform at its
maximum, much less continuously, even when set at the applicable output
limit, that possibility is greater than for professionally fit devices,
for which the audiologist or hearing instrument specialist has, in
effect, limited the output. In further consideration of the differences
between professionally fit and user-customizable devices, we find
additional indications that the safety margin of the proposed output
limits is lower than we initially believed regarding the risks of
cumulative exposure.
Several comments suggested that FDA also reconsider users' ability
to react to loud situations in which continued use of an OTC hearing
aid could present significantly increased risks of injury should the
user not remove the hearing aids or reduce the output. Some comments
observed that users of OTC hearing aids are likely to have
characteristics not shared by the general population. For example, OTC
hearing aid users may be more likely to have reduced dexterity or
experience cognitive difficulties. Such characteristics can hinder
adjusting a device in sufficient time, especially if the controls are
physically small or require navigation (as in opening a software
application on a smartphone to navigate to the correct control
interface).
Other comments noted that, while obviously-loud sounds pose risks
of further hearing impairment, continuous exposure to lower intensities
can pose such risks over a sufficiently long period of device use.
Under the proposed limits, overexposure is possible in scenarios where
the device is set to its maximum (providing the maximum gain), yet the
amplified output does not discomfit the user enough to mitigate the
exposure. Such a scenario would entail an increased risk of impairment
to residual hearing from use of an OTC hearing aid.
The ability for users to act to protect themselves was an important
factor in our proposed output limits (see 86 FR 58150 at 58162), and it
remains so for this final rule. FDA recognizes that some OTC hearing
aid users may need more time or assistance to react to noticeable
overexposure than an average member of the general population. The
required design and electroacoustic performance features for OTC
hearing aids will significantly reduce such risks for the intended
users. For example, a user-adjustable volume control will allow a user
to set and maintain the device's output below the maximum. However,
after considering the diversity of scientific comments, we are
persuaded that our proposal did not adequately account for cumulative
exposure to lower-intensity sounds during daily use over an extended
period of time--on account of users' ability or desire to intervene as
well as the other factors, explained above, that might increase
cumulative exposure and the resulting risks. Since a dosimetry-based
limit is impractical as discussed above, we are lowering the allowable
maximum output to address considerations of cumulative exposure.
4. Declining To Include Gain Limit
Multiple comments, many of which urged FDA to establish or adopt a
lower output limit, recommended that FDA also adopt a gain limit. These
comments contended that a gain limit would improve device safety by
further reducing the risks of over-amplification, primarily due to the
device reaching its gain limit and providing no further amplification
before it reached its output limit (see 86 FR 58150 at 58162). In
effect, a gain limit would lower the output limit.
FDA acknowledges that a gain limit may play a role in the
management of risks from overamplification. However, a gain limit
reduces the ability to adequately amplify soft sound inputs in some
cases, which can lead to decreased device effectiveness and user
satisfaction. Moreover, the appropriate gain for a given device will
depend on device design and features. Imposing a gain limit may
constrain device design and innovation, which could have an undesirable
effect on device benefit for intended users.
In addition to preserving flexibility in device design, FDA is not
requiring a gain limit in order to maximize access to these devices for
the full range of intended users with perceived mild to moderate
hearing impairment. Intended users of these devices are a heterogenous
population with a range of hearing and communication difficulties and
needs. By not requiring a gain limit, the broadest range of intended
users will have access to effective devices. This flexibility empowers
users to customize their hearing aids to their needs, listening
preferences, and communication goals, and it allows for a wider range
of options should users' needs, preferences, and goals change over
time.
FDA is establishing requirements to provide reasonable assurance of
safety and effectiveness of OTC hearing aids for the intended user
population, and further reducing the device's output by establishing a
gain limit is not necessary for such reasonable assurance. Indeed, a
gain limit in this case may detract from such reasonable assurance by
broadly reducing the available amplification for the user and limiting
the range of intended users of the device. Because the appropriate
output limits we are finalizing will sufficiently limit device output,
we are not finalizing a gain limit that would further reduce the
output. (See also the response to Comment 78, describing how frequency
response smoothness helps prevent under- and overamplification of
frequency bands, in effect, a more-focused reduction than a gain
limit.) This also allows manufacturers the flexibility to design their
devices to balance the required output limits with the amplification
needs of the intended user population.
F. Other Device Requirements (Sec. 800.30(e) and (f))
Several comments shared a concern for an influx of unsafe or
ineffective devices to the marketplace, for example, devices that do
not satisfy the requirements of the OTC Hearing Aid Controls because of
lax enforcement and/or manufacturers or sellers evading regulatory
controls necessary for reasonable assurance of safety and effectiveness
of OTC hearing aids. Such comments tended to focus on the risks to
health of violative or non-conforming products, for example, impairment
of
[[Page 50725]]
remaining hearing from excessive device output, injury stemming from
inferior manufacturing practices, or ineffective treatment resulting
from the possible difficulty of distinguishing an OTC hearing aid from
consumer electronics not intended to compensate for hearing loss.
To provide reasonable assurance of safety and effectiveness of OTC
hearing aids, and thereby avoid an influx of unsafe or ineffective
devices, we are establishing requirements for, among other things, the
design and performance of OTC hearing aids. At the same time, the
requirements will not unnecessarily constrain device design or burden
manufacturing, which could hinder innovation or impede adoption and use
of the devices. Further, compliance with regulatory controls is a
concern for all devices, and FDA monitors the marketplace and conducts
regular inspections and other postmarket surveillance as part of
maintaining reasonable assurance of safety and effectiveness.
1. Electroacoustic Performance
(Comment 73) Some comments urged FDA to adopt the same
electroacoustic performance requirements for prescription hearing aids
as those for OTC hearing aids.
(Response) While FDA agrees that prescription hearing aids should
provide high-fidelity amplification for users, we do not agree that
prescription hearing aids should be subject to the same electroacoustic
performance requirements as OTC hearing aids. The requirements for OTC
hearing aids will provide reasonable assurance of safety and
effectiveness without the involvement of a licensed person, such as an
audiologist or hearing instrument specialist, to adjust the device
output and ensure it performs adequately. However, the requirements we
are finalizing for prescription hearing aids presume the involvement of
a licensed person: As prescription devices, they may only be sold to or
on the prescription or other order of a practitioner licensed by law to
use or order the use of the devices (see Sec. 801.109(a)(2)).
The labeling requirements we are finalizing for prescription
hearing aids include technical specifications that an audiologist or
hearing instrument specialist can use to select and adjust the hearing
aid (see 86 FR 58150 at 58164). These requirements are virtually
identical to the long-standing labeling requirements for hearing aids
in former Sec. 801.420(c)(4) upon which professionals rely.
Additionally, we are finalizing a new requirement to state the latency
of the prescription hearing aid, measured with a method that is
accurate and repeatable to within 1.5 ms. This information will be
particularly useful for fitters given evolving hearing aid designs and
sound processing capabilities. However, we are not also establishing a
latency performance limit for prescription hearing aids. The
aforementioned information and the involvement of a licensed person
will provide reasonable assurance of safety and effectiveness of
prescription hearing aids without the additional performance
requirements necessary for OTC hearing aids.
(Comment 74) A comment recommended that the requirements for an OTC
hearing aid sold by a licensed person be no different than those for
sale by a non-licensed person, and that the final rule should clearly
state that preemption would apply to this situation.
(Response) To the extent that this comment recommends that the
requirements for the OTC hearing aid itself be no different when sold
by a licensed person, versus a non-licensed person, FDA agrees with the
comment. The requirements for OTC hearing aids themselves (output
limits, electroacoustic performance, labeling, etc.) that we are
finalizing apply equally to those sold by licensed and non-licensed
persons. To the extent that this comment recommends that State
regulation of the activities associated with the sale of OTC hearing
aids, for example, via licensing requirements, be preempted, we have
addressed that request along with similar comments in the Preemption
sections III.H and VIII.
(Comment 75) A comment suggested that prescription hearing aids
have the same output limit as OTC hearing aids.
(Response) FDA does not agree that prescription hearing aids should
have the same output limit as OTC hearing aids because people with a
more severe degree of hearing loss than perceived moderate impairment
may need additional gain, and therefore would need a higher output,
potentially above limits appropriate for OTC hearing aids. We recognize
that people with more severe hearing impairment can still suffer
further impairment of their remaining hearing, so the device output
must not be too high for them. We are finalizing a requirement, as
proposed, that labeling warn dispensers to exercise special care when
selecting and fitting a hearing aid with an output that exceeds 132 dB
SPL. This warning is nearly the same as the required warning statement
in former Sec. 801.420(c)(2). Nevertheless, the output necessary to
compensate for more severe hearing impairment safely and effectively,
though subject to individual variability, will generally be higher than
would be permissible for OTC hearing aids.
(Comment 76) Comments suggested that FDA require input-controlled
compression for all OTC hearing aids to help significantly reduce the
risk that users could worsen their hearing impairment by using an OTC
hearing aid.
(Response) FDA agrees that input-controlled compression can provide
multiple benefits for OTC hearing aid users. For example, this feature
allows the device to adapt the output dynamically, based on the
listening environment. This can reduce the user interaction necessary
to adjust the device for different situations. Some users find the
feature improves the hearing aid's comfort, contributing to their
satisfaction and encouraging continued use. This in turn can help
accomplish this rule's purposes of promoting wider adoption and use.
However, some users find the feature annoying or distracting, reducing
their satisfaction and discouraging them from using their hearing aids.
Moreover, the feature is not necessary for reasonable assurance of
safety or effectiveness (when the device does not exceed an output of
111 dB SPL). For these reasons, FDA is not requiring input-controlled
compression for all OTC hearing aids. (See also the response to Comment
77 about including noise-cancelling technology.)
(Comment 77) A comment suggested requiring that OTC hearing aids
include noise-cancelling technology to prevent a loss of benefit from
using the devices in noisy environments.
(Response) FDA agrees that noise-cancelling technology can help
hearing aid users in certain situations. For example, the feature can
help improve the clarity of voices by reducing the volume of only
background noise. This can reduce the user interaction necessary to
adjust the device for different situations. However, the feature is not
generally necessary for reasonable assurance of safety or effectiveness
because air-conduction hearing aids can still provide adequate
amplification to achieve effectiveness without the feature, so FDA is
not requiring noise-cancelling technology for all OTC hearing aids.
(See also the response to Comment 76 about including input-controlled
compression.)
(Comment 78) Comments requested that FDA remove the frequency
response smoothness requirements so, these comments asserted, OTC
hearing aids would accommodate all kinds of
[[Page 50726]]
perceived mild to moderate hearing impairment, not just individuals
with typical age-related, sloping hearing impairment.
(Response) Although FDA agrees that OTC hearing aids should be safe
and effective for the breadth of the intended user population with
perceived mild to moderate hearing impairments, we are not removing the
frequency response smoothness requirements for OTC hearing aids. As we
explained in the proposed rule, a smooth frequency response will ensure
that an OTC hearing aid does not under- or overamplify certain sounds
(see 86 FR 58150 at 58164). A device that does not have a smooth
frequency response can, for example, perceptibly distort speech quality
(see 86 FR 58150 at 58164).
Moreover, the proposed frequency response smoothness requirements
do not limit device output to compensating only for typical age-
related, gradually sloping hearing impairment. More specifically, the
frequency response smoothness describes the flatness of the output when
the device is set to provide constant gain as a function of frequency,
that is, when the device is not set to provide frequency shaping. The
idea is that the flatter the response when the device is not set to
provide frequency shaping, the more consistently the device will
achieve any intended frequency shaping to accommodate the user's
customization, for example, to compensate for a sloping hearing loss.
This is similar to how a loudspeaker's frequency response is later
adjusted by an equalizer, which shapes the input signal. In short,
frequency response smoothness does not prevent the device from
appropriately amplifying lower frequencies. Instead, it helps prevent
under- and overamplification at any frequency band that could result
from a device that does not appropriately shape the output. We are
finalizing the smoothness requirements as proposed.
(Comment 79) Some comments proposed that OTC hearing aids have
cutoff limits: if the output were to exceed certain thresholds for a
long-enough time, the device would reduce or stop amplification, even
if the device never exceeded the allowable output limit.
(Response) FDA agrees that an OTC hearing aid user could experience
over-amplification even if the device does not exceed the allowable
output limit. As we explain in section V.E of this document, we have
considered this possibility further and are correspondingly finalizing
output limits lower than we proposed. We also explain in that section
that insufficient data exist to establish regulatory limits for
exposure over time based on dosimetry. As with implementing dosimetry-
based features, manufacturers may establish cutoff limits for their
devices, but FDA is not requiring such features for OTC hearing aids.
(Comment 80) A comment requested that FDA allow greater latency for
OTC hearing aids, suggesting 25 milliseconds (ms). The comment argued
that this delay would still not be perceptible to the user. Other
comments requested that FDA address latency for wireless streaming
technologies, such as Bluetooth, and other hearing aid designs.
(Response) FDA does not agree that allowing greater latency will be
imperceptible. One comment cited for support material that showed four
out of nine people perceived a delay of 25 ms. (Two out of nine
perceived it at 15 ms.) This does not suggest that allowing greater
latency will be equally imperceptible, though such a small sample may
not have yielded generalizable results. Regardless, human hearing
perception can be sensitive to differences longer than 15 ms, depending
on frequencies and conditions, and signal processors for hearing aids
can reliably achieve latencies shorter than 15 ms. Given these
considerations, we do not agree that greater latency will be
imperceptible or that a limit of 15 ms unduly constrains device design.
FDA is not revising the latency limit for OTC hearing aids.
Regarding wireless streaming technologies, the latency limit we are
finalizing is an electroacoustic performance metric that describes how
quickly an OTC hearing aid must produce the output sound relative to
the input sound, that is, the acoustic input (see 86 FR 58150 at
58164). It does not describe the time necessary for an OTC hearing aid
to receive and process a wireless signal after transmission, which can
often exceed 15 ms, even under ideal conditions. In contrast to
electroacoustic performance, FDA has not determined that a wireless
transmission latency limit is generally necessary for reasonable
assurance of safety and effectiveness of OTC hearing aids because air-
conduction hearing aids compensate for impaired hearing primarily by
detecting sounds with on-board microphones. As such, wireless streaming
latency does not generally raise the same perceptual concerns as
electroacoustic latency. Therefore, we are not establishing a wireless
transmission latency limit. (See also the response to Comment 64
regarding labeling for wireless streaming latency.) However, there may
be circumstances where, based on the device's design, wireless
streaming latency does raise the same perceptual concerns as
electroacoustic latency. In such circumstances, manufacturers will
likely need to consider wireless transmission latency for devices that
incorporate such technology.
As for different device designs regarding acoustic transmission,
the latency limit applies. For example, ``open-fit'' devices that allow
some incoming sound to bypass the hearing aid would also need to
respect the latency limit. Moreover, the latency limit is a performance
baseline. Manufacturers may design devices with lower latency should
they want to improve electroacoustic performance.
(Comment 81) Some comments suggested that FDA permit different
acoustic couplers than proposed for the electroacoustic performance
testing requirements. These comments argued that standard 2-cm\3\
couplers would not be the most appropriate for some device designs, and
performance measurements would more accurately reflect device
capabilities if more suitable couplers were permitted.
(Response) FDA agrees that 2-cm\3\ couplers may not be compatible
with some device designs. We are revising the final regulations to
permit use of alternative acoustic couplers that are compatible with
the device. The manufacturer would have to document how use of the
alternative approach is scientifically valid and technically
equivalent.
(Comment 82) A comment requested that FDA prescribe the method to
test latency beyond requiring that measurements be accurate and
repeatable to within 1.5 ms.
(Response) Although FDA is finalizing standardized test methods to
ensure other electroacoustic specifications are comparable across
devices, the comparability of latency is less sensitive to the specific
method. Latency is a measurement of time, so essentially any
scientifically suitable and accurate timing method will produce a
result that is comparable to other suitable and accurate methods, even
though the methods may differ in the specifics. As such, we are
specifying how accurate the timing must be but allowing flexibility for
the specific method. Nevertheless, clause 4.8 of ANSI/CTA-2051:2017
suggests two different methods, either of which is acceptable provided
the testing equipment is sufficiently accurate and precise.
(Comment 83) A comment observed that FDA considered the
electroacoustic performance requirements in ANSI/
[[Page 50727]]
CTA-2051:2017, including the self-generated noise limit. However, FDA
did not specify A-weighted measurements for the self-generated noise
limit in the proposed regulation as the standard does. The comment
suggested FDA specify A weighting consistent with the standard.
(Response) FDA agrees that A weighting is more consistent with the
standard. We are revising the self-generated noise limit in the final
regulation to refer to A-weighted decibels.
2. Design Requirements To Ensure Proper Physical Fit and Prevent User
Injury
(Comment 84) Several comments urged FDA to hold OTC hearing aids to
the same hardware standards as prescription hearing aids. Some of these
comments focused on Quality System requirements (see Comment 95 and our
response). Others focused on equivalent electroacoustic performance.
(Response) FDA agrees that OTC and prescription hearing aids should
both be held to standards appropriate for medical devices. However, we
are not applying all of the same specific rules to both because OTC and
prescription hearing aids differ in important respects, for example,
the intended uses.
Some of the same rules will apply to both. As we explain in the
response to Comment 95, OTC hearing aids will be subject to quality
management system requirements that are appropriate for medical
devices. The same will be true for prescription hearing aids. Thus,
both OTC and prescription hearing aid manufacturers will need to comply
with the same Quality System requirements under part 820, even if their
individual implementations differ in the details. (See also the
response to Comment 96 about a risk-based approach to quality
management systems.)
However, some of the requirements will differ, such as those for
device performance. We explain in the responses to Comments 73 and 75
that OTC and prescription hearing aids have different intended uses,
and therefore, they must satisfy different performance needs. Thus,
having reasonable assurance of safety and effectiveness of both
categories of hearing aids entails different specific requirements for
each category.
(Comment 85) Some comments proposed requiring that eartips for OTC
hearing aids be made of ``medical grade'' materials to prevent
irritation or damage from the components of the device in contact with
the ear canal.
(Response) FDA agrees that contact with substances can cause
adverse tissue reactions like skin irritation; however, the design
requirements that we are finalizing for OTC hearing aids, along with
existing requirements and policies, are sufficient to address the kinds
of materials used.
The design requirements that we are finalizing for OTC hearing aids
include a requirement that the material for the eartip be atraumatic,
which is the same as proposed. As explained in the proposal, atraumatic
materials are those that prevent injuries to the skin and bone, and the
use of atraumatic materials reduces the chance that daily use or
accidental contacts will cause damage to the delicate skin or bone of
the ear (86 FR 58150 at 58165). In evaluating the material for the
eartip to determine whether it meets this requirement, manufacturers
may wish to review FDA's guidance, ``Use of International Standard ISO
10993-1, `Biological evaluation of medical devices--Part 1: Evaluation
and testing within a risk management process,' '' issued September 4,
2020, which describes FDA's approach to biocompatibility evaluation of
medical devices, including considerations and recommendations for
manufacturers.\11\
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\11\ The document is available online at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and.
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As described in the aforementioned guidance, OTC hearing aids
(depending on the specific device) would likely be a surface device in
contact with intact skin. As such, manufacturers should consider the
specific biological effects of cytotoxicity (toxic effects on cells),
sensitization (becoming more sensitive to materials over time), and
irritation or intracutaneous reactivity (a reaction within the layers
of the skin). The use of certain common materials in surface devices
contacting intact skin may help manufacturers to pursue least-
burdensome methods for evaluating biocompatibility.
Additionally, as we explain in the responses to Comments 95, 96,
and 97, OTC hearing aids will be subject to the Quality System
requirements, which will also help provide for reasonable assurance of
safety and effectiveness.
(Comment 86) Several comments suggested requiring that OTC hearing
aids use non-proprietary designs and/or open-platform technology
because, in the commenters' views, proprietary designs or closed
platforms would limit the compatibility of accessories, availability of
replacement parts, or possibility of modifications to the devices.
Other, similar comments proposed that OTC hearing aids have a
standard user interface or support a standard application programming
interface (API) to allow users to access and modify device settings,
perhaps through third-party software, when the manufacturer has not
exposed the desired settings to user control. Some comments identified
a standard API (or some other standard protocol) as a way to enable
device interaction with other electronics of the user's choosing, for
example, a smartphone from a different manufacturer.
(Response) While some OTC hearing aid users may desire such
features, we do not currently consider them necessary for reasonable
assurance of safety and effectiveness of OTC hearing aids generally.
Hearing aids that incorporate proprietary designs and interfaces can be
safe and effective, without interaction with third-party products.
Manufacturers may implement open features, but we are not requiring
them.
(Comment 87) Several comments suggested that all OTC hearing aids
have a user-adjustable volume control because the feature would be
integral to device safety regardless of its output limit. A comment
suggested that all hearing aids should have a volume control built into
the device itself, separate from a software controller (as in, a
``slider'' in a smartphone application, for example).
(Response) FDA agrees that a user-adjustable volume control should
be a design feature of all OTC hearing aids, and we are finalizing such
a requirement under new Sec. 800.30(f)(5). However, although FDA
understands that a physical (that is, built into the device itself)
volume control could provide ready access for some users to adjust the
volume, we are declining to adopt this suggestion.
While some users may find a physical volume control useful, several
comments that FDA received observed that many users of OTC hearing aids
may have limited dexterity, which would in turn limit the usefulness of
a hardware controller, for example, a small dial or push buttons on the
device. Similarly, we received comments emphasizing hearing aid users'
desire for a discreet device, including both its form and its
operation. A user interface, perhaps implemented on a remote control or
a mobile device, will allow design flexibility for manufacturers to
develop and market smaller hearing aids, and adjusting the volume
through such an interface may feel more discreet for many users than
reaching up to the
[[Page 50728]]
device to adjust it, perhaps needing additional effort to manipulate
physically small controls.
This is consistent with the many comments we received urging that
we require the devices to have wireless controls. (See the response to
Comment 94 for further discussion on this topic.) For people who are
less inclined to use software, they may still purchase a device with a
physical volume control or, alternatively, they may still manually
limit the sound exposure by, for example, removing the device, covering
the microphone, or seeking a quieter environment.
(Comment 88) A comment suggested that all OTC hearing aids have an
option for volume limitation and a parental volume control.
(Response) FDA is not adopting these suggestions because the output
limits we are finalizing will provide reasonable assurance of safety
and effectiveness without requiring an additional feature that would
limit the output further. (See also section V.E.4 of this document
explaining why FDA is not establishing a separate gain limit.) However,
we are finalizing a requirement that all OTC hearing aids have a user-
adjustable volume control (see the response to Comment 87).
A parental volume control is likewise not necessary for reasonable
assurance of safety and effectiveness, including cases in which the
caregiver is not the user's parent. Moreover, establishing a
requirement for ``parental control'' may imply that the devices are
intended for people younger than 18, which is not the case for OTC
hearing aids (see 21 U.S.C. 360j(q)(1)(A)(ii)).
(Comment 89) A comment proposed that the user-adjustable volume
control must allow for at least 6 dB of potential adjustment to the
device output to ``ensure perceptual functionality.'' This amount, the
comment asserted, would help significantly reduce the risk that users
could worsen their hearing impairment by using an OTC hearing aid.
Other similar comments suggested that FDA specify the performance
requirements for the volume control in terms of the range.
(Response) FDA is not requiring that a user-adjustable volume
control adjust the volume in 6-dB increments at a minimum, and FDA is
not specifying the range for the volume control.
The comment proposing 6-dB increments asserted that a 3-dB change
in signal intensity is the average needed for users to perceive a
volume difference, thus a 6-dB increment would ensure that users
perceive it. However, FDA expects that users will manipulate the
control until they perceive not only a difference but a satisfactory
output volume, regardless of the size of the increment. Further, a 6-dB
minimum increment may force users to increase the volume more than
desired, providing unnecessarily high amplification while constraining
device design and performance. FDA does not agree that a minimum volume
adjustment increment of 6 dB will appreciably reduce risks or increase
effectiveness.
As for the range over which the volume control must operate, a
specification is not necessary for reasonable assurance of safety or
effectiveness, and it may constrain device design unnecessarily. The
output of an OTC hearing aid may not exceed the applicable limit under
final Sec. 800.30(d) regardless of the performance of the volume
control, so establishing an upper limit would be redundant. As for a
lower limit, a specific minimum setting would generally depend on the
device design. Thus, for similar reasons to not requiring a minimum
increment, we are not requiring a minimum volume setting.
(Comment 90) Comments suggested establishing an absolute limit on
the maximum insertion depth for OTC hearing aids. There was variability
in the range of recommended insertion depth limit ranging from 7.5 mm
to 21 mm, though the most frequent recommendation was 15 mm to 17 mm.
(Response) FDA agrees that a fixed limit on the insertion depth of
an OTC hearing aid is a better measurement than the anatomical landmark
that we proposed (the bony cartilaginous junction). We are finalizing a
fixed insertion depth limit relative to the expected distance from the
eardrum (tympanic membrane). Note that a ``fixed insertion depth
limit'' means a limit that is a specific distance measurement rather
than a more relative description. This meaning is different from
describing a hearing aid as ``fixed length'' (or similar) in reference
to a hearing aid that does not change length. FDA did not propose and
is not finalizing a design requirement that hearing aids have a fixed
length.
As we explained in the proposal, the length of the ear canal can
vary greatly among adults (see 86 FR 58150 at 58165). A fixed insertion
depth limit may be too deep for some individuals, potentially resulting
in injury. Comments noted that a hearing aid inserted too deeply in the
ear canal can cause increased sound pressure levels to be delivered to
the eardrum as well as push earwax deeper into the ear canal. However,
the same fixed depth limit may be too short for others, potentially
reducing device effectiveness. As comments recognized, the hearing aid
must be inserted deeply enough for it to stay in place despite jaw
movement, and deeper insertion also helps with reducing acoustic
feedback and improving gain (amplification). Moreover, deeper insertion
can help reduce the cosmetic impact of the hearing aid, that is, help
it to be less visible, which may reduce self-consciousness or
perceptions of stigma from wearing the device.
Furthermore, we are not aware of any widely accepted method to
describe the measurement of the insertion depth of hearing aids. Ear
canal anatomy varies across individuals, and methods may not agree on
exactly where to start the measurement for various OTC hearing aid
designs. These factors may lead to significantly different measurements
of insertion depth for the same device.
We proposed a limit based on an anatomical landmark, and several
comments characterized the proposal as insufficiently defined and
subject to significant variability across individuals. While
measurements relative to the individual's anatomy would be ideal, we
recognize it is not currently practical, considering the uncertainties
stemming from anatomical variability and insertion depth measurement.
As such, following review of all relevant comments, we have
determined a limit defined by the distance of the innermost (that is,
most medial) component of the hearing aid relative to the eardrum. This
should be a generally understandable and consistently measurable way to
ensure safe design of the device with respect to placement in the ear
canal. Thus, we are limiting the insertion depth to a specific expected
distance (``setback'') from the eardrum (tympanic membrane): 10 mm from
the innermost component of the device to the eardrum. In establishing
this limit, we considered that its primary purpose is to minimize the
risk of injury to the tympanic membrane and the skin of the bony
portion of the ear canal. We believe that an OTC hearing aid designed
to have a 10-mm setback will minimize the risk of injury from inserting
the device too deeply while allowing for individual anatomic
variability, but without unduly limiting effectiveness.
For adults, the average length of the ear canal has been estimated
to be 23-28 mm (Refs. 12 and 13). Using an average length of 25 mm,
manufacturers may generally assume that the maximum insertion depth of
a hearing aid designed with a setback of 10 mm
[[Page 50729]]
from the tympanic membrane would be approximately 15 mm. We acknowledge
that an OTC hearing aid design based on this setback limit may result
in an actual setback of somewhat less than 10 mm in users with shorter
than average ear canals. However, we believe that the limit is
conservative enough to ensure safety even in these cases. Some comments
pointed out that receiver-in-the-canal hearing aids can have insertion
depths of 20-21 mm. However, an audiologist or hearing instrument
specialist typically fits such a device. We do not currently consider
such insertion depths to be appropriate for OTC hearing aids.
(Comment 91) Some comments proposed either encouraging or requiring
that OTC hearing aids use only instant-fit eartips or customized
eartips, fabricated based on non-invasive ear scans, to couple the
device to the ear canal. A few of these comments further suggested that
FDA require a licensed person to fabricate custom earmolds or ear
shells.
(Response) FDA is not requiring the use of instant-fit eartips or
eartips fabricated based on non-invasive ear scans because currently
classified devices to create earmolds and ear shells are not intended
for the user of the OTC hearing aid. Instead, earmolds and ear shells
are intended for use by a hearing health professional because they
often require an impression-making procedure. As some comments noted,
improperly taking the impression can leave behind impression material
or injure the ear. Separately requiring instant-fit (or non-invasively
created) eartips is unnecessary for reasonable assurance of safety and
effectiveness of OTC hearing aids.
However, a manufacturer may design an OTC hearing aid intended to
be compatible with custom earmolds or ear shells, that is, the use of
such is optional but not necessary. (A device intended to rely on
taking impressions would imply the need for a licensed person, hence
the device would not be ``available'' over the counter.) We do not wish
to preclude this possibility, nor do we wish to limit the kinds of
eartips in the future that may be safe and effective for users of OTC
hearing aids. Considering the current regulatory framework and a desire
to avoid unduly constraining design, we are not adopting this
suggestion.
(Comment 92) A comment suggested that OTC hearing aids with
removable eartips must have a specific minimum amount of force to
remove the eartips from the device. The comment asserted this would
help prevent an eartip from falling off the device and lodging in the
ear canal.
(Response) FDA is not requiring that eartips have a minimum force
to detach them from the device because determining a generally
applicable threshold would be impractical and unnecessary. The force
exerted on an eartip during normal removal or wear may vary depending
on the device design, materials, and the user's anatomy, among other
factors. Furthermore, any minimum force requirement would need to
ensure that the force was not so great as to hinder the ability of
users to change eartips, particularly for users who have limited
dexterity. However, we note that manufacturers of devices with
removable eartips should consider the risks of accidental separation of
an eartip within the canal and ensure their specific designs prevent
such adverse events. Although we are not establishing a threshold for
force that would apply to all OTC hearing aids, manufacturers should
incorporate robust device designs that help provide for safe and
effective hearing aids.
(Comment 93) Comments suggested that FDA require a self-
administered hearing test to accompany OTC hearing aids because users
are not always able to determine whether their hearing loss is mild or
moderate.
(Response) While a self-administered hearing test may be one way
for users to control OTC hearing aids and customize the devices to
their hearing needs, we are not requiring that self-administered
hearing tests accompany OTC hearing aids. In some cases, a test is not
necessary to achieve safe and effective amplification to compensate for
perceived mild to moderate hearing impairment. For example, a self-
fitting strategy could do so by guiding the user through a setup
process that is not a diagnostic hearing test. Further, users may wish
to obtain a hearing test by some other means, for example, by
voluntarily visiting an audiologist. The inclusion of a hearing test
with the device, in either case, would be unnecessary. Manufacturers
may decide to incorporate a validated diagnostic function as
appropriate for their device designs, but we do not agree that it
should be a requirement for all OTC hearing aids.
(Comment 94) A comment suggested requiring that OTC hearing aids
integrate Bluetooth or telecoil technology so users can configure the
devices with their smartphones.
(Response) While Bluetooth or other wireless technologies may be
desirable for some users of OTC hearing aids, we are not requiring such
functionality. We acknowledge that, by definition, a wireless hearing
aid will incorporate wireless technology in its programming or use, and
we would expect that, with current technologies, most OTC hearing aids
will incorporate wireless.
However, we also expect that wireless technology will continue to
evolve, and specifying protocols or capabilities may unnecessarily
constrain design and hinder innovation. For example, telecoil
technology may currently be practical for relatively larger form factor
devices, but users may not desire the functionality or the size
necessary to incorporate a telecoil, for example, if preferring a
smaller device. Other methods of connectivity may also develop, and
such devices may be appropriate for OTC availability despite lacking
wireless technology. In sum, requiring such features could potentially
increase cost while hindering innovation and reducing adoption and use
of OTC hearing aids. (See also the response to Comment 87 about
requiring a physical control for volume adjustment.)
3. Quality System Requirements
In the proposal, we sought input on the Quality System requirements
that would apply to OTC hearing aids but also explained that any
changes to the Quality System requirements would be proposed in a
separate rulemaking proceeding (86 FR 58150 at 58165). Below we
summarize the input that we received and respond to it.
(Comment 95) Many comments supported FDA's proposal that all
applicable Quality System requirements under part 820 remain in force
for the manufacture of OTC hearing aids. Most of these comments
emphasized that hearing aids are medical devices and, as such, should
be subject to commensurate manufacturing requirements. Most such
comments also opined that the current requirements are not unduly
burdensome or unreasonably costly, and in fact, can aid device
development. For example, as one such comment stated, the application
of Quality System requirements helps manufacturers to identify risks
and problems early, helping to focus resources on the most promising
new ideas. Such requirements allow manufacturers to identify what works
well and effectively investigate what does not. The requirements
collectively help reduce costs and time to market.
(Response) We have further considered the applicability of Quality
System requirements under part 820, and we are not modifying the
applicability of the requirements for
[[Page 50730]]
OTC hearing aids. The device quality system requirements are part of
the general controls for all devices that help provide for reasonable
assurance of safety and effectiveness. In the proposal, we explained
that we had previously received conflicting feedback on the
possibilities but that we believed a quality management system specific
to medical devices was appropriate (see 86 FR 58150 at 58165).
Moreover, we consider the Quality System requirements to be
interdependent yet inherently flexible (see 86 FR 58150 at 58165). We
continue to hold these views, and although we again received
conflicting comments, we agree that the requirements are not unduly
burdensome. (See also the response to Comment 96, explaining the risk-
based nature of the Quality System requirements and the revisions FDA
is proposing in a separate rulemaking.)
(Comment 96) A comment proposed that the extent of Quality System
controls be based on the risks of device use and the complexity of the
device. It suggested that manufacturers be allowed to maintain a
Declaration of Conformity, along with supporting documentation, that
the manufacturer could provide to FDA upon request.
(Response) As we explained in the proposed rule, the Quality System
requirements under part 820 are inherently flexible (see 86 FR 58150 at
58165). We have elsewhere explained that one of the purposes of the
flexibility is to allow manufacturers to develop and follow procedures
and processes that are appropriate to a given device and according to
the state of the art for designing and manufacturing that device (see
87 FR 10119 at 10121, February 23, 2022). Moreover, FDA is proposing to
harmonize part 820 with an international consensus standard,
International Organization for Standardization (ISO) 13485:2016,
``Medical devices--Quality management systems--Requirements for
regulatory purposes,'' that has an even more flexible approach to
quality based on risk management (see 87 FR 10119 at 10122). Thus,
although FDA agrees that Quality System controls should be based in
part on the risks of device use, we are not modifying this final rule
because the requirements are already flexible and risk-based, and we
are elsewhere proposing to harmonize the risk-based approach with a yet
more flexible international consensus standard.
Regarding the use of Declarations of Conformity, section
514(c)(1)(A) of the FD&C Act provides that a person may submit a
Declaration of Conformity to an FDA-recognized consensus standard to
meet a requirement under the FD&C Act (see 21 U.S.C. 360d(c)(1)(A)). If
a person elects to use a Declaration of Conformity in such a way, the
person must provide a Declaration of Conformity certifying that the
device in question is in conformity with an FDA-recognized consensus
standard (see 21 U.S.C. 360d(c)(1)(B)). That is, Declarations of
Conformity appertain to devices themselves; to declare that a device is
in conformity to a standard for a quality management system is not
equivalent to declaring that the quality management system itself
conforms to the standard. For more information on using Declarations of
Conformity, you may wish to refer to FDA's guidance, ``Appropriate Use
of Voluntary Consensus Standards in Premarket Submissions for Medical
Devices,'' issued September 14, 2018.\12\
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\12\ The document is available online at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-standards-premarket-submissions-medical-devices.
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For systems, a certificate (or certification process) is an
analogous mechanism to document and declare conformity. However, in our
separate proposal regarding harmonization of Quality System
requirements with an international consensus standard, we stated that
FDA does not intend to exempt from FDA inspections manufacturers that
are certified as conforming to the standard (see 87 FR 10119 at 10128).
Further, FDA does not intend to develop a certification program or
issue such certificates (see 87 FR 10119 at 10128). As explained
elsewhere in this document, FDA does not view OTC hearing aids as a
unique case for purposes of Quality System requirements. As such, we
are declining to modify how manufacturers may use Declarations of
Conformity or to accept certifications in lieu of demonstrating
compliance under FDA's usual policies for the manufacture of OTC
hearing aids. Should FDA determine to follow a different general
approach to certifications for purposes of quality management, we will
announce such a determination in the final rule based on our proposal
to harmonize part 820 with ISO 13485:2016.
(Comment 97) Multiple comments proposed that OTC hearing aids be
exempt from the Quality System requirements of part 820. Some of these
comments stated that the requirements of the Hearing Aid Restrictions,
Sec. Sec. 801.420 and 801.421, addressed safety concerns with
specialized labeling but that modern devices no longer raise these
concerns. As such, these commenters viewed the requirements under part
820 as unnecessary.
(Response) FDA does not agree that specialized labeling for, or the
diminution of past risks of, hearing aids suggests that the OTC
category of hearing aids be exempt from Quality System requirements.
Rather, FDA expects that the establishment and continued application of
an appropriate Quality System would help reduce device risks and
support effectiveness, and are an important control to help provide for
reasonable assurance of safety and effectiveness. Further, an
appropriate Quality System serves different purposes than labeling, and
the two are not substitutes for each other. For example, a Quality
System includes production and process controls to ensure that a device
conforms to its specifications (see Sec. 820.70(a)). Labeling does not
serve this purpose and cannot substitute for production and process
controls. We note that the implementation of a Quality System entails
risk-based decision-making and that the system's appropriateness is
related to the device. The Quality System requirements are inherently
flexible, and comments we received agree that a Quality System that
complies with part 820 is not unduly burdensome.
4. Choice and Specification of Standards
(Comment 98) Some comments suggested that FDA not specify the exact
editions of the standards we are incorporating by reference. In this
way, the commenters sought to simplify the process for keeping
regulations up to date with new editions of the standards, as the
respective organizations develop and publish them.
(Response) While FDA appreciates the value in keeping regulations
in sync with consensus standards, we are not adopting this suggestion
as doing so would impermissibly allow the standards organizations to
change regulatory requirements without FDA going through notice-and-
comment rulemaking. In addition, we note that, under the incorporation
by reference regulations issued by the Office of the Federal Register,
incorporation by reference of a publication is limited to a specific
edition and ``future amendments or revisions of the publication are not
included'' (1 CFR 51.1(f)). Thus, under Federal regulations, we cannot
incorporate by reference a specific standard and all future editions of
that standard. By incorporating all or parts of a standard by
reference, we are referring to those parts exactly as they are in that
specific edition, at the time we finalize the rule.
[[Page 50731]]
(Comment 99) Some comments observed that FDA proposed different
consensus standards for regulatory purposes for OTC and prescription
hearing aids, specifically ANSI/CTA-2051:2017 and ANSI/ASA S3.22-2014,
respectively. These comments raised concerns that the different
standards treat the same hearing aid performance aspects differently,
which could be confusing or create inconsistencies. They proposed that
FDA use only one standard for both OTC and prescription hearing aids.
(Response) FDA does not agree that these standards treat the same
performance aspects differently. These standards are not incompatible
or divergent for purposes of regulating OTC and prescription hearing
aids. Rather, the standards serve different purposes, which is
appropriate for regulating different categories of hearing aids.
As we explained in the proposal, ANSI/ASA S3.22-2014 specifies test
methods and measurement tolerances, not device performance (see 86 FR
58150 at 58163). For example, ANSI/ASA S3.22-2014 does not specify an
output limit. Instead, it describes to manufacturers one way to
determine the maximum output, using an OSPL90 curve over a specific
bandwidth, and the measurement tolerance for it, that the maximum
``shall not exceed that specified by the manufacturer plus 3 dB,'' (see
clause 6.2). ANSI/ASA S3.22-2014 does not help provide for safety and
effectiveness by establishing a baseline for performance but rather, in
effect, by defining common terms to describe device performance.
ANSI/CTA-2051:2017 itself integrates use of those common terms. For
example, ANSI/CTA-2051:2017 relies on ANSI/ASA S3.22-2014 to describe
test methods by using OSPL90 curves. (However, we note that in one
place, the standard refers to ANSI/ASA S3.22-2009, rather than 2014, as
a normative reference.) In other words, one standard builds on the
other: ANSI/CTA-2051:2017 specifies how well an amplifier should
perform instead of leaving it solely to the manufacturer (as ANSI/ASA
S3.22-2014 does for hearing aids), but in either case, the
specifications are measured and tested based on ANSI/ASA S3.22-2014.
(Comment 100) Some comments objected to the use of ANSI/CTA-
2051:2017 for purposes of regulating hearing aids on the basis that an
industry group developed the standard rather than a disinterested
organization. Other similar comments alternatively or additionally
objected that the standard was developed for consumer electronics but
not medical devices. In either case or both, these comments argued, the
use of the standard is not appropriate for the regulation of OTC
hearing aids.
(Response) FDA acknowledges that, in some cases, standards
developed specifically for medical devices may be more appropriate for
regulatory purposes. For example, we are continuing to apply Quality
System requirements specific to manufacturing medical devices, as
opposed to a quality management system intended for other kinds of
manufacturers. We note that the comments questioning the use of ANSI/
CTA-2051:2017, as opposed to a standard specifically for medical
devices, generally did not question the test methods or performance
specifications specifically--the major exception being the device
output limit in clause 4.3, as discussed in the previous section. (Some
comments did question the performance specifications on grounds besides
being adopted from a consumer-technology standard. See, for example,
Comment 78 and the response.)
Some of these comments suggested that FDA use ANSI/ASA S3.22-2014
instead because that standard applies specifically to hearing aids.
However, as explained in the response to Comment 99, the standards do
not serve the same purposes, so they are not substitutes for each
other. Additionally, as explained in response to Comment 99, although
ANSI/CTA-2051:2017 specifies how well an amplifier should perform
instead of leaving it solely to the manufacturer (as ANSI/ASA S3.22-
2014 does for hearing aids), in either case, the specifications are
measured and tested based on ANSI/ASA S3.22-2014. Although ANSI/CTA-
2051:2017 was intended for personal sound amplification more generally
than hearing aids, as discussed elsewhere in this document (see also
the discussion in 86 FR 58150 at 58163-64), the performance
specifications we are adopting based on that standard will provide
reasonable assurance of safety and effectiveness of OTC hearing aids.
We are therefore not replacing it with a different standard.
(Comment 101) A comment stated that FDA violated the Information
Quality Act by not subjecting the ``CTA Standard'' to pre-dissemination
review requirements. This comment argued that FDA cannot therefore use
the ``CTA Standard'' in support of the output limits.
(Response) Neither the Information Quality Act (IQA) nor any
information quality guidelines require FDA to engage in the pre-
dissemination review this comment said is required.
The IQA, or Data Quality Act,\13\ required the Director of the
Office of Management and Budget (OMB) to issue ``guidelines . . . that
provide policy and procedural guidance to Federal agencies for ensuring
and maximizing the quality, objectivity, utility, and integrity of
information (including statistical information) disseminated by Federal
agencies.'' Under the IQA, the guidelines OMB issues must require each
covered Federal agency to issue guidelines concerning information
``disseminated by the agency,'' and to ``establish administrative
mechanisms allowing affected persons to seek and obtain correction of
information maintained and disseminated by the agency that does not
comply'' with OMB's guidelines. OMB's initial guidelines, as corrected,
were published in February 2002. ``Guidelines for Ensuring and
Maximizing the Quality, Objectivity, Utility, and Integrity of
Information Disseminated by Federal Agencies; Republication'' (67 FR
8452, February 22, 2002) (``OMB Guidelines''). HHS's guidelines, which
include the FDA guidelines, were published in September 2002 and have
been periodically updated (``HHS/FDA Guidelines'').\14\
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\13\ Section 515 of the Treasury and General Government
Appropriations Act, 2001, Public Law 106-554 (2000) (codified at 44
U.S.C. 3516 note).
\14\ These are available at https://aspe.hhs.gov/reports/hhs-guidelines-ensuring-maximizing-quality-objectivity-utility-integrity-information-disseminated.
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In 2005, OMB published its Final Information Quality Bulletin for
Peer Review, which addressed ``peer review of scientific information
disseminations that contain findings or conclusions that represent the
official position of one or more agencies of the Federal government''
(70 FR 2664 at 2666, January 14, 2005). In 2019, OMB issued a
Memorandum entitled ``Improving Implementation of the Information
Quality Act'' (``Improving Implementation Memorandum''),\15\ the
purpose of which was to ``reinforce, clarify, and interpret agency
responsibilities with regard to responsibilities under the Information
Quality Act (IQA).''
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\15\ M-19-15 (April 24, 2019).
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As an initial matter, the IQA ``orders the Office of Management and
Budget to draft guidelines concerning information quality and specifies
what those guidelines should contain.'' Salt Inst. v. Leavitt, 440 F.3d
156, 159 (4th Cir. 2006). The IQA does not require pre-dissemination
review. Nevertheless, to the extent pre-dissemination review may be
required under the OMB Guidelines, it would not apply here, as
[[Page 50732]]
FDA did not disseminate the referenced information.
The specific source this comment asserted required pre-
dissemination review is ANSI/CTA-2051, a voluntary consensus standard
established by the ANSI and the CTA. In the proposal, FDA explained
that the Agency is basing its proposed output limits on physiological
data and stakeholder input. ANSI/CTA-2051:2017 is one of the scientific
sources FDA has considered. Other data and scientific sources
considered are described in the proposal and include a national
workplace safety guideline from the National Institute for Occupational
Safety and Health, comments from speakers at a 2017 public workshop
meeting held by NASEM, and public comments stemming from a 2016 FDA
public workshop (Refs. 14 and 15).
The IQA and associated information quality guidelines concern only
information ``disseminated'' by a Federal agency. ANSI/CTA-2051:2017 is
not within the scope of the IQA and OMB guidelines because it is
disseminated by ANSI and CTA, not a Federal agency. See, e.g., HHS
Guidelines section I.D.2.h. (`` `Dissemination' means agency initiated
or sponsored distribution of information to the public.''). Because a
Federal agency did not develop or disseminate ANSI/CTA-2051:2017, ANSI/
CTA-2051:2017 is not within the scope of the IQA or any information
quality guidelines, and is not subject to any pre-dissemination review
requirements arising under them.
FDA is committed to using and developing high quality information
and follows the applicable requirements and guidelines. See, e.g., 67
FR 8452 at 8459 (``Agencies shall treat information quality as integral
to every step of an agency's development of information, including
creation, collection, maintenance, and dissemination.''). Additionally,
as discussed elsewhere in this document and as discussed in the
proposal (see 86 FR 58150 at 58163-64), FDA believes the performance
specifications for OTC hearing aids, having taken into account ANSI/
CTA-2051:2017, will provide reasonable assurance of safety and
effectiveness of these devices.
(Comment 102) A comment stated that FDA has denied the right of a
work group, composed of several third-party trade groups and/or
professional associations, to seek or secure adoption of a purported
voluntary consensus standard it has put forth (``work group's
standard''). This comment stated that the National Technology Transfer
and Advancement Act, OMB Circular No. A-119, the Administrative
Procedure Act, the Information Quality Act, and Executive Order 12866
give this work group that right. The comment further stated that, to
remedy the alleged violation(s), FDA must incorporate the work group's
standard into an amended notice of proposed rulemaking or the final
rule.
(Response) None of the authorities this comment cited require FDA
to adopt the work group's standard.
Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) states that ``all Federal agencies and departments
shall use technical standards that are developed or adopted by
voluntary consensus standards bodies'' unless their use is
``inconsistent with applicable law or otherwise impractical.'' Public
Law 104-113, section 12(d)(1), (3) (1996). Office of Management and
Budget Circular No. A-119, as revised (Circular A-119), implements
NTTAA section 12(d) by establishing policies on Federal use of
voluntary consensus standards, among other things. Contrary to this
comment's assertion, the work group's standard does not fit within
Circular A-119's definition of a ``voluntary consensus standard.''
According to this comment, the work group's standard was created by
several trade groups and/or professional associations. So the work
group's standard is not a voluntary consensus standard within the
meaning of Circular A-119, because it was not ``developed or adopted''
by an organization that ``plan[s], develop[s], establish[es], or
coordinate[s] voluntary consensus standards using agreed-upon
procedures.'' Circular A-119 section 4.A., 4.A.1. But even if the work
group's standard were a voluntary consensus standard, nothing in NTTAA
or Circular A-119 would require FDA to choose it over ANSI/CTA-
2051:2017, the voluntary consensus standard FDA included in the
proposal. As explained in the proposal, ANSI/CTA-2051:2017 is, to FDA's
knowledge, the first voluntary consensus standard to describe
performance characteristics for hearing amplifiers. In the proposal,
FDA proposed to establish as requirements a subset of specifications
from ANSI/CTA-2051:2017, in conjunction with other proposals. FDA's
actions are consistent with NTTAA and Circular A-119. Indeed, Circular
A-119 states that it ``does not establish a preference among standards
developed in the private sector.'' Id. section 6.g.
This comment did not identify any language in the Administrative
Procedure Act (APA) or IQA it claimed would require FDA to adopt the
work group's standard. And these statutes do not require FDA to adopt
any particular standard. These are procedural statutes that do not
demand specific substantive outcomes, let alone use by FDA of any
commenter's preferred standard.
Finally, this comment asserted that the ``compelling need
requirement'' set forth in Executive Order 12866 prohibits FDA's
consideration of ANSI/CTA-2051. Under Executive Order 12866, Federal
agencies should issue only such regulations as are required by law, are
necessary to interpret the law, or are made necessary by compelling
public need, such as material failures of private markets to protect or
improve the health and safety of the public, the environment, or the
well-being of the American people. Regulatory Planning and Review,
section 1, 58 FR 51735 (September 30, 1993). FDA has complied with this
provision of Executive Order 12866 because the regulation it is issuing
is ``required by law.'' See FDARA, section 709(b) (2017). In any event,
Executive Order 12866 ``reaffirm[s] the primacy of Federal agencies in
the regulatory decision-making process,'' gives ``due regard to the
discretion that has been entrusted to the Federal agencies,''
recognizes that ``Federal agencies are the repositories of significant
substantive expertise and experience,'' and does not ``displac[e] the
agencies' authority or responsibilities, as authorized by law.''
Executive Order 12866 pmbl., sections 2(a), 9; see In re United Mine
Workers of Am. Int'l Union, 190 F.3d 545, 551 (D.C. Cir. 1999) (stating
that Executive Order 12866 ``does not purport'' to ``set aside
congressional legislation''). Executive Order 12866 certainly does not
prohibit or require adoption of any particular standard. See Helicopter
Ass'n Int'l, Inc. v. FAA, 722 F.3d 430, 439 (D.C. Cir. 2013)
(explaining that Executive Order 12866 does not ``create[] private
rights'').
(Comment 103) A comment stated that a third party provided a
standard to FDA in advance of the proposal, and that FDA's alleged
failure to consider that standard before issuing the proposal is
arbitrary and capricious and therefore a violation of the
Administrative Procedure Act.
(Response) The APA's notice-and-comment procedures provide the
requirements that govern this rulemaking, and do not require the kind
of pre-proposal special consideration this comment discussed.
Consistent with the APA, FDA published in the Federal Register, a
``[g]eneral notice of proposed rulemaking'' that included, among other
things, ``the terms or substance of the
[[Page 50733]]
proposed rule or a description of the subjects and issues involved.'' 5
U.S.C. 553(b)(3). The APA states that, ``[a]fter notice required''
thereby, the agency ``shall give interested persons an opportunity to
participate in the rule making through submission of written data,
views, or arguments.'' Id. section 553(c). FDA has complied with this
provision by, in the proposal, soliciting public comment.
FDA has considered the comments received in response to the
proposal, and is in this preamble responding as appropriate. But the
APA's notice-and-comment procedures, which require that the public be
given an opportunity to participate in the rule making only ``[a]fter''
publication of the notice of proposed rulemaking (NPRM), id., do not
require that FDA consider or respond to any comments received in
advance of the NPRM.
G. Conditions for OTC Sale (Sec. 800.30(g))
Many comments on the conditions for sale of OTC hearing aids sought
more stringent conditions or enforcement to prevent possible misuses of
OTC hearing aids. Although FDA is attentive to these concerns, we are
also mindful of unduly impeding access by creating barriers rather than
removing them if appropriate (see also 86 FR 58150 at 58166).
(Comment 104) Some comments suggested that FDA require any seller
of OTC hearing aids to staff customer support in the United States with
licensed persons, for customers to meet with them via telemedicine
technology.
(Response) FDA is not adopting these suggestions because this would
require the involvement of a licensed person in the sale of an OTC
hearing aid, contrary to section 520(q)(1)(A)(v) of the FD&C Act and
section 709(b)(2)(D) of FDARA. Further, the requirements in this
rulemaking will provide reasonable assurance of safety and
effectiveness of OTC hearing aids without the involvement of a licensed
person. In any case, FDA would expect such a requirement to entail
substantial, perhaps prohibitive, costs for sellers in addition to a
significant amount of time to develop or contract for such services.
Neither would be compatible with the purposes of this rulemaking,
including the purpose of broadening the kinds of sellers that can offer
OTC hearing aids.
(Comment 105) Multiple comments proposed a requirement for age
verification prior to the sale or delivery of an OTC hearing aid.
Similarly, comments proposed a requirement for purchasers to affirm
that they are at least 18 years old at the time of purchase. Some of
these additionally proposed that purchasers acknowledge or agree that
the OTC hearing aid is not for use by anyone younger than 18 years old.
(Response) FDA is not adopting these suggestions. While people
younger than 18 should not use hearing aids without the involvement of
a licensed person, such as an ear-nose-throat doctor, we do not agree
that the risk warrants age verification at this time.
We considered other purchases that require age verification and
found that, in such cases, the risks to individuals and the public
health were significantly greater than the risks posed by the use of
OTC hearing aids by people younger than 18. Furthermore, we do not
expect that OTC hearing aids will be as attractive for purchase by
people younger than 18 as other age-restricted products that do require
verification. Thus, the benefit of mandatory age verification would
likely be small relative to the risks posed to the individual by OTC
hearing aids compared to the benefit of restricting and risks posed by
other age-restricted products.
At the same time, we would expect mandatory age verification, or
similar processes like certifications or acknowledgments, to increase
the difficulty or complexity of purchases by people who are the
intended users, and can benefit from the use, of OTC hearing aids.
Since one of the purposes of this rulemaking is to promote the public
health by reducing or eliminating barriers to access for such people,
we considered which approach is likely to benefit the public health
more. In this case, lower-income people or people who live in
relatively isolated conditions (for example, in rural areas) are more
likely to benefit from broadened access while at the same time being
less able to present official documentation of their age (for example,
because they lack a driver's license or are buying hearing aids by
mail). We have determined that the public health is better served at
this time by not imposing requirements for age verification,
certification, or acknowledgment.
The above considerations also took into account that we are
finalizing requirements to improve the warnings against use of OTC
hearing aids by people younger than 18. We are also finalizing the
condition for sale that will prohibit sale of OTC hearing aids to or
for people younger than 18 under new Sec. 800.30(g)(1). These
requirements, along with the others in this rule, will help provide
reasonable assurance of safety and effectiveness of OTC hearing aids
for the intended users without the need for age verification. We expect
that sellers will likely adopt their own practices, tailored to their
business models, to prevent violating this condition for sale and/or
engaging in a prohibited act. Such practices may, but are not required
to, entail age verification by checking a government-issued
photographic identification. However, in some cases, the seller may not
need to check a government-issued photographic identification, for
example, when the seller has personal knowledge of the purchaser's age
or may otherwise be certain that the purchaser is 18 or older.
(Comment 106) Several comments proposed that FDA enhance
enforcement of legal requirements for labeling, sales, or other
provisions for legally marketing hearing aids. Similar comments
suggested that FDA enhance enforcement for selling non-compliant
products as hearing aids, for example, by making false or misleading
statements or improperly avoiding premarket requirements for devices.
Other such comments urge in any case that FDA monitor the sales of OTC
hearing aids and/or non-compliant consumer electronics marketed as
hearing aids.
(Response) FDA intends to apply existing practices for monitoring
the market and will take action, including enforcement as necessary and
appropriate. Should stakeholders wish to call FDA's attention to
potential concerns that we may not otherwise learn, including potential
regulatory misconduct, they may file a report sometimes known as a
trade complaint. Anyone may file such a report (a complaint), and we
encourage people to include supporting and contact information for
possible followup questions. However, the reports can be anonymous.
More information about the process is available on FDA's website:
https://www.fda.gov/medical-devices/medical-device-safety/reporting-allegations-regulatory-misconduct. See also the response to Comment 122
regarding the role of State authorities in enforcing requirements
applicable to OTC hearing aids.
Moreover, we are finalizing labeling requirements that describe the
process of reporting adverse events to FDA (see final Sec. Sec.
800.30(c)(2)(iii)(F) and 801.422(c)(2)(ii)(E)). Section 709(d) of FDARA
directs FDA to report on an analysis of adverse events relating to OTC
hearing aids not later than 2 years after the date we issue this final
rule. FDA expects this information to be helpful in identifying and
analyzing device risk trends, and it will likely inform enforcement
prioritization.
[[Page 50734]]
(Comment 107) Comments suggested that FDA impose a penalty on
persons who sell an OTC hearing aid that is used by a child.
(Response) The FD&C Act sets forth penalties for prohibited acts
respecting devices and electronic products as described in section IV
of this document (see 21 U.S.C. 331, 333, 360oo and 360pp(b)).
Prohibited acts include, among other things, doing or causing a variety
of acts involving adulterated and/or misbranded devices (see, e.g., 21
U.S.C. 331(a)-(c), 331(k)). In turn, a device is deemed adulterated
and/or misbranded for a variety of reasons (see 21 U.S.C. 351 and 352).
For example, an OTC hearing aid sold to or for a person younger than 18
would not, among other deficiencies, bear adequate directions for use
for such users. The hearing aid would be deemed misbranded (see 21
U.S.C. 352(f)), and certain activities with respect to the misbranded
device (for example, the introduction of the misbranded device into
interstate commerce) would be a prohibited act in that example and
subject to the penalties under the FD&C Act.
(Comment 108) Several comments suggested that FDA establish a
variety of post-sale requirements on manufacturers or sellers of OTC
hearing aids. Such proposals included requirements that manufacturers
or sellers: accept returns for a certain minimum period (either for
money back or credit), warrant certain features or components for a
given period, guaranty products or services in some way, and/or provide
a minimum rescission period (a period in which a buyer could cancel the
purchase).
Many of these comments mentioned user satisfaction and that, if
users buy an unsatisfactory device and are unable to return or exchange
it, such users could incur unnecessary expenses to obtain a
satisfactory OTC hearing aid or forego hearing aid use entirely. Other
such comments described a benefit or need to establish a national
standard, as opposed to one that varies by State, to encourage broader
availability of the devices. The proposed time periods for the
application of such requirements varied but were generally 30, 45, 60,
or 90 days after purchase.
(Response) FDA is not establishing the suggested post-sale
requirements on manufacturers or sellers of OTC hearing aids. We are
finalizing a requirement for OTC hearing aid labeling to provide notice
of the manufacturer's return policy. We believe this adequately
addresses the concern mentioned in the comments that the risk of
obtaining an unsatisfactory OTC hearing aid may result in people
foregoing hearing aid use entirely, and that additional requirements in
this regard are not necessary to provide a reasonable assurance of
safety and effectiveness for OTC hearing aids. To the extent the post-
sale requirements proposed in the comments are aimed at consumer
protection rather than providing a reasonable assurance of safety and
effectiveness for OTC hearing aids, we note that there may be other
Federal laws, administered by other agencies that provide this type of
consumer protection. Likewise, many States have existing requirements
that also address these types of consumer protection concerns. See the
response to Comment 122 regarding the applicability of State consumer
protection requirements.
(Comment 109) A comment proposed that FDA prohibit the resale of
OTC hearing aids by consumers. The comment expressed a need for
appropriate disinfection of used hearing aids and the need to apply
labeling required for used hearing aids. The comment asserted that used
OTC hearing aids should be returned by the vendor to the manufacturer
for it to take the necessary steps to market a used OTC hearing aid.
(Response) Although FDA agrees that all used hearing aids should be
labeled as required and adequately reprocessed regardless of the type
of reseller, we are declining to revise the proposed rule to
incorporate this suggestion. We are finalizing the requirement that if
the OTC hearing aid is used or rebuilt, the outside package must
declare that fact, and we have modified the design requirements for OTC
hearing aids to specify that if the OTC hearing aid is used or rebuilt,
it must be adequately reprocessed for the next user prior to sale. OTC
hearing aids must meet these requirements regardless of the type of
reseller. We believe that the requirements that we are finalizing for
OTC hearing aids provide for reasonable assurance of safety and
effectiveness, and prohibiting resale of an OTC hearing aid by a
consumer will not add anything and will likely be impractical to
enforce.
(Comment 110) Comments proposed that FDA require referrals to
physicians for prescription hearing aids when a user or prospective
user manifests any of the ``red flag'' conditions. However, one such
comment proposed an option for waivers since, it asserted, most people
with a ``red flag'' condition have already been advised to seek or
previously sought an examination by a physician.
(Response) FDA is declining this suggestion because it would
require the involvement of a licensed person in the use of OTC hearing
aids in some cases, and it is not necessary for reasonable assurance of
safety and effectiveness of OTC hearing aids. We believe that the
required prominent warnings and other statements in the labeling of OTC
hearing aids are sufficient to advise users and prospective users to
consult hearing health care providers, including ENT doctors, in
certain circumstances, such as when experiencing certain pathological
(``red flag'') conditions. For these reasons, we are not including an
examination or waiver requirement for the OTC category of hearing aids.
(Comment 111) Some comments urged FDA to establish generally more-
stringent requirements for the sale of OTC hearing aids. These comments
reasoned that because hearing aids are medical devices, are
technologically complex, and/or intended to compensate for a complex
condition, they should not be as easily available as other devices such
as bandages (see, e.g., 21 CFR 880.5075, classifying elastic bandages).
(Response) Except as explained elsewhere in this document, FDA is
declining this suggestion. We are establishing requirements that are
sufficiently stringent to provide reasonable assurance of safety and
effectiveness of OTC hearing aids. We have taken into account, among
other considerations, the seriousness of hearing impairment as well as
the complexity of both the impairment and the technology intended to
compensate for it. More stringent requirements are not necessary to
provide reasonable assurance of safety and effectiveness, and the
requirements we are establishing generally do not depend on the sales
environment, provided the environment does not cause the device to be
adulterated, misbranded, or otherwise out of compliance with applicable
requirements (see, e.g., 21 U.S.C. 351(a)(2)(A) regarding adulteration
if held under insanitary conditions).
Moreover, the extent to which the availability of OTC hearing aids
is comparable to that of elastic bandages does not suggest the devices
themselves are otherwise similar. Similarly, the broad availability of
elastic bandages does not cause the devices to be less safe and
effective for their intended use(s), and the same would be true for OTC
hearing aids. The purposes of this rule include promoting broader
availability of OTC hearing aids while establishing requirements that
will provide reasonable assurance of safety and effectiveness, which is
[[Page 50735]]
incompatible with establishing unnecessarily stringent regulations.
(Comment 112) Comments suggested that sellers of OTC hearing aids
be required to keep the devices behind the counter or in a locked
cabinet to prevent people younger than 18 from purchasing the devices.
(Response) FDA is declining this suggestion because we are allowing
flexibility for sellers to determine how to comply with the condition
for sale that prohibits the sale of OTC hearing aids to or for people
younger than 18. FDA intends this flexibility to minimize regulatory
burdens while promoting access to safe and effective devices. If a
seller determines that it can comply with the condition for sale
without special storage provisions, then it need not make such storage
provisions. Mandating special storage provisions for such sellers of
OTC hearing aids would add unnecessary burdens. However, a seller may
decide keeping the devices in a locked display case and verifying the
purchaser's age with a form of photographic identification will be the
most practical approach for its circumstances. (See also the response
to Comment 105 regarding age verification.) Although we are not
mandating a specific approach to ensure that OTC hearing aids are not
sold to people younger than 18, FDA expects that sellers will implement
an approach appropriate for their circumstances.
(Comment 113) A comment suggested pairing the purchase of an OTC
hearing aid with membership in an organization that could serve first-
time hearing aid users, for example, by assisting with or explaining
the initial selection and purchase of an OTC hearing aid.
(Response) FDA is not adopting this suggestion as condition for
sale of OTC hearing aids. Although such organizations can provide
useful and valuable services for users and prospective users of hearing
aids, FDA proposed and is finalizing requirements for OTC hearing aids
that would provide reasonable assurance of safety and effectiveness
without the involvement of a licensed person. Requiring the involvement
of such an organization is neither necessary for reasonable assurance
of safety and effectiveness nor consistent with the approach we are
taking to establish the OTC category for hearing aids to promote
broader availability of OTC hearing aids.
Further, as we explained in the proposal, we expect this final rule
to lower costs of hearing aids by unbundling the purchase of hearing
aids from professional services, including professional advice,
fitting, adjustment, or maintenance to make the devices available over
the counter (see 86 FR 58150 at 58172). Requiring membership in an
organization with the purchase of OTC hearing aids would be contrary to
our intent of unbundling services and device purchases. In that vein,
we would expect that membership with such an organization would present
costs to users, either directly, as in a membership fee, or indirectly,
as in increasing the purchase price of a device. Thus, although users
and prospective users may choose to seek membership with organizations
to obtain related benefits, we do not agree that such membership should
be required with the purchase of an OTC hearing aid.
(Comment 114) A comment proposed that FDA require sellers of OTC
hearing aids to obtain certifications for relevant standards developed
by the ISO as well as comply with appropriate Quality System
requirements. For example, dispensers might conform to ISO 21388:2020,
``Acoustics--Hearing aid fitting management.''
(Response) FDA is not requiring sellers of OTC hearing aids that
are not manufacturers to comply with part 820 requirements for a
Quality System or conform to consensus standards. An OTC hearing aid,
by definition, is a device that, among other qualities, allows the user
to control and customize it to the user's hearing needs, without the
involvement of a licensed person (see 21 U.S.C. 360j(q)(1)(A)(iii) and
(v)). Further, multiple provisions of this rule are intended to ensure
that persons do not incur special licensing obligations or the
equivalent (certifications, for example) on account of commercial
activity involving OTC hearing aids (see, e.g., final Sec.
800.30(h)(2)(i)). As such, requiring a seller of OTC hearing aids to be
specially licensed or certified is both unnecessary for reasonable
assurance of safety and effectiveness of OTC hearing aids and
inconsistent with the approach we are taking to establish the OTC
category for hearing aids.
Additionally, the scope of part 820 extends to manufacturers of
finished devices, as Sec. 820.3(o) defines the term, but generally not
other persons (see Sec. 820.1(a)(1)), and the requirements of part 820
are not intended to extend to sellers who are not manufacturers.
Instead, part 820 specifies that, among other controls, manufacturers
must ensure that device labeling, packaging and shipping containers
maintain label and device integrity during customary conditions of
processing, storage, handling, and distribution (see Sec. Sec.
820.120(a) and 820.130).
We likewise observe that the consensus standard ISO 21388:2020
applies to hearing aid fitting management (see clause 1), but not non-
licensed persons (i.e., non-hearing aid professionals). As such, this
standard is not likely to apply to sellers of OTC hearing aids who are
not licensed persons. As we explained above, sellers of OTC hearing
aids are not required to have a specialized license or the equivalent.
Nevertheless, FDA acknowledges that quality management may also be
useful to many persons who are not manufacturers or hearing aid
professionals (as ISO 21388:2020 defines the term). Some concepts in
part 820, ISO 21388:2020, or ISO 13485:2016, for example, may help
inform such other person's determination of best practices. A number of
standards exist for other persons to implement quality management
systems, for example, ISO 9001:2015, ``Quality management systems--
Requirements,'' and those persons may wish to obtain related
certifications and advertise as such. However, FDA has determined that
special licensing (or its equivalent) is not necessary, as explained,
and we are not requiring sellers of OTC hearing aids that are not
manufacturers to comply with part 820 or conform to ISO 21388:2020, ISO
13485:2016, or any other consensus standard.
(Comment 115) A comment proposed that FDA protect consumers from
predatory practices throughout the supply chain for OTC hearing aids.
It specifically referred to unnecessarily collecting or sharing private
information by or with several kinds of persons: manufactures,
retailers, medical practitioners, payment processors, service
providers, device monitoring and configuration providers, data
aggregators, computer hosting services, and platforms.
(Response) FDA is declining this proposal because it is not
necessary for reasonable assurance of safety and effectiveness of OTC
hearing aids. Moreover, although certain deceptive practices would be
prohibited under the FD&C Act, other Federal and State agencies
establish and enforce such requirements as those concerning protection
of private information. For example, if a seller were to modify the
labeling of an OTC hearing aid to mislead prospective purchasers, that
would constitute misbranding of a device while held for sale in
interstate commerce, which is prohibited under the FD&C Act (see, e.g.,
21 U.S.C. 331(k)). Deceiving prospective purchasers in such a way may
additionally violate Federal and/or State requirements that FDA is not
[[Page 50736]]
responsible for administering or enforcing. For more information about
the kinds of health fraud issues FDA addresses, which includes unlawful
sales of medical products, you may visit our website: https://www.fda.gov/consumers/health-fraud-scams.
However, FDA does not generally administer or enforce requirements
respecting predatory commercial practices that do not involve the
safety or effectiveness of FDA-regulated products. Should stakeholders
wish to raise concerns for deceptive practices not related to
requirements that FDA administers or enforces, they should approach the
appropriate Federal or State agencies. For example, stakeholders may
wish to report fraud to the Federal Trade Commission's Bureau of
Consumer Protection. More information is available online: https://www.ftc.gov/about-ftc/bureaus-offices/bureau-consumer-protection.
(Additional Revision 4) FDA is finalizing a condition for sale for
OTC hearing aids that sellers may not sell the devices over the counter
unless the principal display panel of the outside package labeling bear
prominent marks identifying the device as ``OTC'' and a ``hearing
aid.'' As explained in Additional Revision 2 (section III.D.3), FDA is
finalizing a requirement for the outside package labeling to bear the
marks to assist purchasers and others, including retailers and State
agencies. However, in some cases, purchasers may not view the principal
display panel of the package prior to purchase. For example, a person
shopping online may filter a list of the devices offered by the seller
with ``OTC'' and view only pictures of the device itself. This
condition for sale will help ensure that only OTC hearing aids are sold
as such, particularly for purchasers who shop online or by mail. This
is necessary for reasonable assurance of safety and effectiveness of
OTC hearing aids because it provides assurances that non-OTC hearing
aids or non-hearing aids will not be sold as or confused for OTC
hearing aids.
H. Preemption Provisions (Sec. 800.30(h))
Most comments on preemption sought clarification on the effects of
this rule on State and local requirements, including consumer
protections and professional licensing requirements. Many strongly
supported preserving States' roles in protecting prospective and
current hearing aid users.
(Comment 116) Several comments suggested that FDA define ``restrict
or interfere'' in the FDARA preemption provision because these terms
are ambiguous. Specifically, one suggestion was that FDA define
``restrict or interfere'' to pertain only to State and local laws that
prevent or create an obstacle to a commercial activity involving OTC
hearing aids so that State consumer protection laws that pertain to
commercial activity involving OTC hearing aids, such as a warranty
requirement and mandatory returns for OTC hearing aids, would not be
preempted. Another suggestion was that FDA define ``restrict or
interfere'' to mean ``present actual legal or procedural impediment to
the exclusion of business disincentives.'' One comment expressed
concerns that return requirements could be viewed as interfering with
distribution of OTC hearing aids because such requirements make
distribution chains more complicated and potentially more expensive;
warranty requirements would, by mandating servicing of OTC hearing
aids, interfere with the servicing of the devices; and both kinds of
requirements could be viewed as discouraging the sale of OTC hearing
aids by increasing prices for patients.
(Response) FDA declines to include the definitions suggested by
comments because the Agency is concerned that the suggested definitions
may not be consistent with ``restrict or interfere with'' in section
709(b)(4) of FDARA. For example, the dictionary defines ``restrict'' to
mean ``to confine within bounds,'' Merriam-Webster at https://www.merriam-webster.com/dictionary/restrict, and this definition seems
somewhat different from ``prevent or create an obstacle'' or ``present
actual legal or procedural impediments.''
Instead of adopting the definitions proposed by the comments or
some other definition, in assessing whether a State or local
requirement would ``restrict or interfere with'' commercial activity
involving OTC hearing aids, FDA intends to consider, among other
things, the ordinary meaning of these terms in the context of section
709 of FDARA, including the objectives of section 709, and the specific
facts, such as the specific language of the State or local requirement
and the effects of the requirement on commercial activity involving OTC
hearing aids.
One of the reasons for the proposed definitions of ``restrict or
interfere'' in the comments appears to be the concern that State
consumer protection laws, such as those that provide for a return
period or warranty for hearing aids, would be preempted under section
709(b)(4) of FDARA. For a discussion of this topic, see the response to
Comment 122.
FDA notes that ``restrict or interfere with'' is just one element
of the FDARA preemption provision in section 709(b)(4). In other words,
there are other elements to consider in assessing whether a State or
local requirement is preempted under section 709(b)(4) of FDARA, such
as whether the State or local requirement is ``specifically related to
hearing products.'' As discussed in the proposal, we do not interpret
FDARA to preempt generally applicable requirements, i.e., requirements
that relate to other products in addition to hearing products, to
services not specific to hearing products, or to unfair trade practices
in which the requirements are not limited to hearing products. See 86
FR 58150 at 58167 for further discussion.
(Comment 117) A comment suggested that FDA consider requests from
States for exemption from Federal preemption as OTC devices enter the
market. Another comment suggested that FDA state in the final rule that
the existing processes in Sec. 808.20 (21 CFR 808.20) (which relate to
requests for exemption from Federal preemption under section 521 of the
FD&C Act) will continue to apply, and that FDA will find against
preemption when consistent with the statutory language and ``in the
public interest.''
(Response) As discussed in the proposal, section 709(b)(4) of FDARA
established preemption specific to OTC hearing aids that is different
from the general rule for preemption under section 521 of the FD&C Act.
See 86 FR 58150 at 58166. Unlike section 521 of the FD&C Act, section
709(b)(4) of FDARA does not provide for any exemptions for State or
local requirements that fall within this provision. Therefore, FDA is
unable to provide exemptions from preemption for State or local
requirements that fall within the scope of section 709(b)(4).
Section 521 of the FD&C Act does provide for exemption from
preemption for State or local requirements that fall within this
provision, and the procedures for requesting and granting or denying an
exemption are provided in part 808, subpart B (21 CFR part 808, subpart
B). Section 808.20 will continue to apply to State or local
requirements that fall within section 521 of the FD&C Act, such as
requirements for prescription hearing aids. FDA did not propose any
changes to Sec. 808.20.
FDA intends to assess preemption consistent with the statutory
language of section 709(b)(4) of FDARA for State or local requirements
that fall within this provision. We believe this approach to assessing
preemption is consistent with the Supreme Court's approach to Federal
preemption. See, e.g., Puerto
[[Page 50737]]
Rico v. Franklin Cal. Tax-Free Trust, 579 U.S. 115, 125 (2016)
(explaining that ``because the statute contains an express preemption
clause, we do not invoke any presumption against preemption but instead
focus on the plain wording of the clause, which necessarily contains
the best evidence of Congress' pre-emptive intent.'' (citations and
internal quotations omitted)). Additionally, FDA believes that this
approach will achieve the objectives of section 709 of FDARA, which
include promoting access to safe and effective OTC hearing aids for
adults with perceived mild to moderate hearing impairment, and in so
doing, will be in the public interest. FDA also intends to assess
preemption consistent with section 521 of the FD&C Act for State or
local requirements that fall within this provision, and consider
exemption from preemption when requested in accordance with Sec.
808.20. As indicated in Sec. 808.20, FDA considers, among other
things, information on how the public health may be benefitted if an
exemption is granted.
(Comment 118) A comment suggested that FDA set up an informal
process by which States could request feedback from the Agency about
whether specific requirements are preempted under section 709(b)(4) of
FDARA. Another comment requested that FDA specify in the final rule
that the process in Sec. 808.5(a) (21 CFR 808.5(a)) apply to State and
local requirements concerning hearing products because this process
would increase transparency.
(Response) At this time, FDA does not believe it is necessary to
set up a separate informal process for States or localities to request
feedback from the Agency about whether specific requirements are
preempted under section 709(b)(4) of FDARA because there are existing
informal processes that States or localities can use to make such
requests. For example, State or localities that have questions about
preemption may contact the Center for Devices and Radiological Health
(CDRH)'s Ombudsman at [email protected] or FDA's
Intergovernmental Affairs Staff at [email protected]. (CDRH's Division of
Industry and Consumer Education can also answer general questions
regarding device regulation.) Additionally, we note that Sec. 808.5(a)
does not set forth a separate process but rather relies on the advisory
opinion process in Sec. 10.85 (21 CFR 10.85). States or localities may
request an advisory opinion under Sec. 10.85 with respect to whether
FDA regards a particular State or local requirement as preempted under
section 709(b)(4) of FDARA.
(Comment 119) Two comments noted that part 808 includes a list of
the types of State or local requirements that are not preempted, and
requested that FDA expand this list with additional examples pertaining
to hearing aids, such as requirements that relate to warranties,
returns, and the sale of hearing aids for users under 18 years of age.
(Response) The list in part 808 of the types of State or local
requirements that are not preempted pertains to preemption under
section 521 of the FD&C Act. Specifically, Sec. 808.1(d) provides
examples of the types of State or local requirements that are not
preempted by section 521 of the FD&C Act, including examples of State
or local requirements that are not considered ``requirements applicable
to a device'' under section 521 of the FD&C Act.
However, providing general categories of State or local requirement
on hearing aids that are not preempted under section 709(b)(4) of FDARA
would be challenging because preemption under this section depends in
part on whether the requirement would ``restrict or interfere with''
commercial activity involving OTC hearing aids. Whether a State or
local requirement would ``restrict or interfere with'' commercial
activity involving OTC hearing aids will depend on the specific facts,
including the specific language of the State or local requirement and
the effects of the requirement.
We note that in the proposal, we did provide specific examples of
State or local requirements that we believe would or would not be
preempted under section 709(b)(4) of FDARA. See 86 FR 58150 at 58167-
68. Additionally, as discussed in the proposal, we do not interpret
section 709(b)(4) of FDARA to preempt generally applicable
requirements, i.e., requirements that relate to other products in
addition to hearing products, to services not specific to hearing
products, or to unfair trade practices in which the requirements are
not limited to hearing products. See 86 FR 58150 at 58167 for further
discussion. However, we noted that if a State or local requirement
appears on its face to be generally applicable, but in practice it was
specifically related to hearing products and would restrict or
interfere with commercial activity involving OTC hearing aids, the
requirement would be preempted. See 86 FR 58150 at 58167.
Further, State or local requirements specifically related to
hearing products would not be preempted under section 709(b)(4) of
FDARA if they would not restrict or interfere with commercial activity
involving OTC hearing aids. For example, we believe that reasonable
return or warranty requirements for OTC hearing aids would likely
promote, rather than restrict or interfere with, commercial activity
involving OTC hearing aids by reducing the financial risk to
purchasers. For further discussion of this topic, see the response to
Comment 122.
We also note that section 709(b)(5) of FDARA specifies, ``[n]othing
in this section shall be construed to modify or otherwise affect the
ability of any person to exercise a private right of action under any
State or Federal product liability, tort, warranty, contract, or
consumer protection law.'' Therefore, laws that fall within the scope
of this savings clause would not be preempted under section 709(b)(4)
of FDARA provided that they do not conflict with the OTC Hearing Aid
Controls or frustrate the purposes and objectives of section 709 of
FDARA. See, e.g., Am. Tel. and Tel. Co. v. Central Office Tel., Inc.,
524 U.S. 214, 226 (1998) (holding that a remedies savings clause in the
Communications Act of 1934 did not save State laws that were
inconsistent with Federal law); Automobile Importers of America, Inc.
v. Minnesota, 871 F.2d 717, 722 (8th Cir. 1989) (although the relevant
Federal statute had a broad savings clause, the court stated ``State
legislation is preempted if compliance with the state law frustrates
the purposes and objectives of federal law'').
States or localities that have questions about preemption may
contact CDRH's Ombudsman at [email protected] or FDA's
Intergovernmental Affairs Staff at [email protected], or they may request
an advisory opinion under Sec. 10.85 with respect to whether FDA
regards a particular State or local requirement as preempted under
section 709(b)(4) of FDARA.
The OTC Hearing Aid Controls in Sec. 800.30 do not apply to
hearing aids intended for users under 18 years of age. Hearing aids
intended for users under 18 years of age would be considered
prescription hearing aids as defined in Sec. Sec. 800.30(b) and
801.422(b). State or local requirements governing the sale of hearing
aids for users under 18 years of age would fall within the scope of
section 521 of the FD&C Act, and therefore, that section and part 808
would continue to apply. To the extent that a State or local
requirement is preempted under section 521 of the FD&C Act, the State
or political subdivision may apply for exemption from preemption in
accordance with part 808, subpart B.
(Comment 120) A comment from an association of State Attorneys
General
[[Page 50738]]
stated that ``the proposed rule includes broad language that could be
interpreted to repeal virtually all the state-requested exemptions from
preemption issued by the FDA since 1980--even those related exclusively
to non-OTC hearing aids'' and that this could create confusion and
unnecessary litigation.
(Response) While we are removing most of the regulations codifying
the exemption decisions, we are doing so because we are repealing or
revising the specific counterpart Federal regulations that preempted
State and local requirements respecting devices. In addition,
preemption specific to OTC hearing aids would generally nullify the
exemptions to the extent the State or local requirements would apply to
OTC hearing aids except in certain specific circumstances.
With respect to OTC hearing aids, as discussed in the proposal,
section 709(b)(4) of FDARA established preemption specific to OTC
hearing aids that is different from the general rule for preemption
under section 521 of the FD&C Act. See 86 FR 58150 at 58166. The FDARA
preemption provision preempts State and local requirements specifically
related to hearing products that would restrict or interfere with
commercial activity involving OTC hearing aids, and that are different
from, in addition to, or otherwise not identical to regulations issued
under FDARA section 709(b). Unlike section 521 of the FD&C Act, section
709(b)(4) of FDARA does not provide for any exemptions for State or
local requirements that fall within this provision. Therefore, FDA is
unable to continue in effect any previously granted exemptions from
preemption for State or local requirements that fall within the scope
of section 709(b)(4) of FDARA.
With respect to prescription hearing aids and other State and local
requirements for hearing aids not otherwise preempted by FDARA section
709(b)(4), FDA is removing all of the regulations in part 808 related
to hearing aids; that is, almost all regulations codifying the previous
decisions in Sec. Sec. 808.53 through 808.101, except for the portions
of Sec. 808.55 (California) that do not relate solely to hearing aids.
As discussed in the proposal, those exemptions are no longer applicable
because this final rule repeals or revises the underlying Federal
requirements from which those exemptions were granted. See 86 FR 58150
at 58170. In addition, FDA is aware that several States have modified
their requirements that were the subject of the exemption decisions
since they applied for exemptions, in which case the exemption decision
may no longer be applicable.
We note that removal of these exemptions does not itself mean that
those State or local laws are now preempted given that we are repealing
or revising the specific counterpart regulations. For example, the
repeal of the conditions for sale in Sec. 801.421 means that State or
local requirements that differed from, or were in addition to, the
repealed counterpart Federal requirements will no longer be preempted
under section 521(a) of the FD&C Act (see Sec. 808.1(d)). However,
some of the new requirements we are establishing in this rule would
implicate preemption under section 521(a) of the FD&C Act. For example,
the prescription hearing aid labeling requirements set forth in Sec.
801.422 will preempt certain State or local requirements that are
different from, or in addition to, those Federal requirements. These
new requirements are similar but not identical to those in Sec.
801.420 and include substantive changes. To the extent that any
previously granted petitions for exemptions related to labeling
requirements, any such exemptions would be rendered inapplicable due to
changes in the underlying Federal requirements from which the
exemptions were granted.
States or localities that have questions about preemption may
contact CDRH's Ombudsman at [email protected] or FDA's
Intergovernmental Affairs Staff at [email protected], or they may request
an advisory opinion under Sec. 10.85 with respect to whether FDA
regards a particular State or local requirement as preempted.
(Comment 121) A comment from the Rhode Island Department of Health
noted that Rhode Island General Laws sections 5-49-2.1 and 2.2 contain
provisions that would require consumers or purchasers to obtain a
certificate of need from a physician who attests that the individual is
in need of a hearing aid, and therefore requested that FDA retain Sec.
808.89, which denied Rhode Island's request for exemption from
preemption. Doing so, the comment said, would align with FDA's approach
of authorizing non-physician licensed hearing professionals to make
determinations of need and would also benefit consumers by reducing
unnecessary costs and added time to the process of obtaining a hearing
aid.
(Response) FDA has decided not to retain Sec. 808.89, because the
repeal of the conditions for sale in Sec. 801.421 substantively
changes the underlying Federal requirements against which the previous
denial of exemption from preemption was made. The repeal of Sec.
801.421 means Rhode Island General Laws sections 5-49-2.1 and 2.2 are
no longer preempted under section 521(a) of the FD&C Act, because no
counterpart Federal requirement exists (see Sec. 808.1(d)). Without
that preemption, the previous denial would have no effect even were we
to retain the regulation.
However, section 709(b)(4) of FDARA would separately preempt the
Rhode Island provisions to a certain extent, regardless of our previous
exemption decisions and whether or not Sec. 808.89 were retained. For
example, to the extent the Rhode Island laws require a certificate of
need from a physician for the sale of OTC hearing aids, they are now
preempted by FDARA section 709(b)(4), because they are specifically
related to hearing products, would restrict or interfere with
commercial activity involving OTC hearing aids, and are different from,
in addition to, or otherwise not identical to, FDA's regulations issued
under FDARA section 709(b).
(Comment 122) Some comments expressed concern that State consumer
protections would be preempted. For example, one comment stated that
many States tie consumer protections, such as return requirements, for
purchasers of hearing aids to licensing requirements, and stated that
these protections would be preempted under the proposed rule. To
address the concern, comments recommended that Federal consumer
protections, such as requiring that hearing aid sales be accompanied by
a receipt, information relating to warranty, and mandatory return or
trial period, be established, for example as conditions for sale under
Sec. 800.30(g).
(Response) FDA declines to include the requirements suggested by
comments because at this time, the Agency believes requiring that OTC
hearing aid sales be accompanied by a receipt, information relating to
warranty, and mandatory return or trial period is not necessary to
provide reasonable assurance of the safety and effectiveness of OTC
hearing aids.
FDA notes that the preemption provision in Sec. 800.30(h)(1) is
intended to incorporate the preemption provision in section 709(b)(4)
of FDARA. In other words, the preemption provision in Sec.
800.30(h)(1) simply reflects the statute, which expresses clear
Congressional intent to preempt certain State and local requirements.
As explained in the proposal, FDA decided to codify the FDARA
preemption provision in the regulations to assist stakeholders in
understanding the legal framework for OTC hearing aids given that the
FDARA
[[Page 50739]]
preemption provision was not incorporated into the FD&C Act (a process
known as U.S. Code classification). 86 FR 58150 at 58166. In this
response, FDA focuses on the express preemption provision in section
709(b)(4) of FDARA but notes that there are other types of preemption
that may apply such as conflict preemption. See, e.g., Nat'l Fedn. of
the Blind v. United Airlines, Inc., 813 F.3d 718, 724 (9th Cir. 2016)
(describing conflict preemption in addition to express preemption).
Whether a State or local requirement is preempted under section
709(b)(4) of FDARA would depend on the specific facts, including the
language of the requirement and the effects of the requirement on
commercial activity involving OTC hearing aids. However, FDA believes
that many State or local consumer protection requirements would not be
preempted under section 709(b)(4) of FDARA because they are not
``specifically related to hearing products'' or would not ``restrict or
interfere with'' commercial activity involving OTC hearing aids. As
discussed in the proposal, we do not interpret FDARA to preempt
generally applicable requirements, i.e., requirements that relate to
other products in addition to hearing products, to services not
specific to hearing products, or to unfair trade practices in which the
requirements are not limited to hearing products. See 86 FR 58150 at
58167. For example, generally, we would not consider a State or local
warranty requirement for assistive devices to be ``specifically related
to hearing products'' under section 709(b)(4) of FDARA because the
requirement relates to other products (e.g., wheelchairs) in addition
to hearing products.
Whether a State or local consumer protection requirement that
specifically related to hearing products would ``restrict or interfere
with'' commercial activity involving OTC hearing aids would depend on
the specific facts. However, generally, FDA believes that State or
local requirements that provide for a reasonable warranty or return
period for hearing aids (e.g., 60-day period) would likely promote,
rather than restrict or interfere with, commercial activity involving
OTC hearing aids. Such requirements may help to encourage people who
could benefit from an OTC hearing aid to purchase the device by
reducing their financial risk. As discussed in the proposal, despite
the high prevalence and public health impact of hearing loss, only
about one-fifth of people who could benefit from a hearing aid seek
intervention, likely due to barriers such as high cost. 86 FR 58150 at
58151. An important objective of section 709 is to lower some of the
barriers and improve access to these devices for people who could
benefit from them. See id.; see also ``FDA User Fee Agreements:
Improving Medical Product Regulation and Innovation for Patients, Part
I,'' Hearing before the Comm. on Health, Education, Labor, and
Pensions, 115th Cong. 115-255 (2017), at 74 (Remarks by Sen. Elizabeth
Warren regarding S. 670, the Over-the-Counter Hearing Aid Act of 2017,
which was largely incorporated into section 709 of FDARA, indicating
that this legislation was intended to improve access and affordability
to safe and effective OTC hearing aids for millions of consumers who
could benefit from these devices); ``Examining Improvements to the
Regulation of Medical Technologies,'' Hearing before the Subcomm. on
Health of the H. Comm. on Energy and Commerce, 115th Cong. 115-28
(2017), at 3 (Statement of Rep. Michael C. Burgess regarding H.R. 1652,
the Over-the-Counter Hearing Aid Act of 2017, which was largely
incorporated into section 709 of FDARA, stating that this bill was
introduced ``to safely increase access and affordability in the hearing
aid market for millions of Americans from whom it would benefit.'').
Additionally, State or local requirements that provide for
reasonable disclosure of the terms of sale in a receipt or similar
document would likely promote, rather than restrict or interfere with,
commercial activity involving OTC hearing aids by providing important
information in writing, such as return or warranty information, to help
people with mild to moderate hearing impairment make fully informed
purchasing decisions.
Congress also recognized the importance of maintaining certain
State consumer protection laws as reflected in section 709(b)(5) of
FDARA. Specifically, section 709(b)(5) states, ``Nothing in this
section shall be construed to modify or otherwise affect the ability of
any person to exercise a private right of action under any State or
Federal product liability, tort, warranty, contract, or consumer
protection law.'' Therefore, laws that fall within this savings clause
would not be preempted unless they conflict with the OTC Hearing Aid
Controls or frustrate the purposes and objectives of section 709 of
FDARA. See, e.g., Am. Tel. and Tel. Co. v. Central Office Tel., Inc.,
524 U.S. 214, 226 (1998) (holding that a remedies savings clause in the
Communications Act of 1934 did not save state laws that were
inconsistent with federal law); Automobile Importers of America, Inc.
v. Minnesota, 871 F.2d 717, 722 (8th Cir. 1989) (although the relevant
Federal statute had a broad savings clause, the court stated ``State
legislation is preempted if compliance with the state law frustrates
the purposes and objectives of federal law'').
With regard to State or local requirements that tie consumer
protections to licensing requirements, the consumer protections are not
necessarily preempted. As we explained in the proposal, under section
709(b)(4) of FDARA, a State or local government cannot require persons
engaged in commercial activity involving OTC hearing aids to undertake
special licensing or equivalent activities solely on that basis (see 86
FR 58150 at 58158). However, such persons who voluntarily identify as a
licensed person would be subject to corresponding State or local
requirements for such licensed persons, including consumer protection
requirements, to the extent that the State or local requirements do not
restrict or interfere with commercial activity involving OTC hearing
aids (see section 709(b)(4) of FDARA; see also the discussion in 86 FR
58150 at 58158).
Therefore, the issue is not necessarily that the consumer
protections are preempted, but rather the issue is that the consumer
protections are tied to the licensing requirements. Thus, to the extent
that consumers purchase OTC hearing aids from non-licensed persons,
they may not get the additional consumer protections they would get if
they purchased the OTC hearing aid from a licensed person. However,
Congress made clear that any State or local requirement for the
involvement or intervention of a licensed person for consumers to
access OTC hearing aids is preempted under section 709(b)(4) of FDARA.
Even if certain consumer protections are not required as part of the
sale of OTC hearing aids by non-licensed persons, we do not believe
that consumers who purchase OTC hearing aids from non-licensed persons
will be left without consumer protections. In addition to consumer
protection laws administered by the Federal Trade Commission, many
States have generally applicable consumer protection requirements that
would not be preempted under section 709(b)(4) of FDARA, such as those
that address unfair and deceptive business practices, false or
misleading advertising, warranties, etc.
(Comment 123) A comment suggested that FDA preempt State
requirements for hearing aids as they apply to OTC hearing aids but
that such requirements
[[Page 50740]]
should continue to apply to prescription hearing aids. Another comment
expressed concern that State hearing aid laws that are not severable
could be preempted as applied to all hearing aids.
(Response) If a State requirement does not fall within section
709(b)(5) of FDARA and is preempted under section 709(b)(4) of FDARA,
FDA would consider it to be preempted to the extent that it applies to
OTC hearing aids. Such State requirement may continue to apply to
prescription hearing aids unless the requirement is preempted under
section 521 of the FD&C Act.
(Comment 124) A comment noted that there are State statutes and
rules that refer to Sec. Sec. 801.420 and 801.421 or incorporate the
same or similar language contained in those provisions, and requested
input on whether such State laws would continue to apply or whether
they would be preempted by the new Federal rules. The comment also
encouraged FDA to consider using the existing sections to capture the
new labeling requirements or special controls because using the
existing sections may be beneficial for State laws that refer to those
sections.
(Response) State laws or rules that incorporate language that is
the same as, or substantially identical to, the language contained in
former Sec. 801.421 may continue in effect as applied to prescription
hearing aids. However, one exception is the statement that was required
under Sec. 801.421(a)(2)(iii). Specifically, Sec. 801.421(a)(2)(iii)
required that the hearing aid dispenser affords the prospective user
the opportunity to sign the following statement: ``I have been advised
by (Hearing aid dispenser's name) that the Food and Drug Administration
has determined that my best health interest would be served if I had a
medical evaluation by a licensed physician (preferably a physician who
specializes in diseases of the ear) before purchasing a hearing aid. I
do not wish a medical evaluation before purchasing a hearing aid.''
State or local laws or rules that require this statement would no
longer be in effect because this statement was based on the waiver of
the medical evaluation that was required under Sec. 801.421, which FDA
is repealing.
Because Sec. 801.420 was issued under section 520(e) of the FD&C
Act (among other authorities), and FDA is not relying on this authority
for the revised labeling requirements for prescription hearing aids,
FDA has decided to establish the revised labeling requirements in new
Sec. 801.422. In the labeling requirements for prescription hearing
aids in Sec. 801.422, FDA has retained in substance most of the
labeling requirements that were in Sec. 801.420 but also made some
revisions. Whether State hearing aid labeling requirements that
incorporate language from Sec. 801.420 are preempted as applied to
prescription hearing aids due to the new labeling requirements in Sec.
801.422 depends on whether they are different from, or are in addition
to, the new requirements. If they are equal to, or substantially
identical to, the requirements in Sec. 801.422, they would not be
preempted as applied to prescription hearing aids. See Sec.
808.1(d)(2). State hearing aid labeling requirements incorporating
language from Sec. 801.420 would be preempted as applied to OTC
hearing aids if they are different from, in addition to, or otherwise
not identical to, the OTC hearing aid labeling requirements in Sec.
800.30. See section 709(b)(4) of FDARA.
We note that the requirements in Sec. Sec. 801.420 and 801.421
were considered general controls that applied to all hearing aids
regardless of the device's classification. In other words, these
requirements were not special controls under section 513(a)(1)(B) of
the FD&C Act. Similarly, the labeling requirements for prescription
hearing aids in Sec. 801.422 are considered general controls that
apply to all prescription hearing aids regardless of the device's
classification. Special controls apply to class II devices and the
special controls for a class II hearing aid are specified in the
particular classification for the hearing aid (e.g., Sec. 874.3305).
(Comment 125) Comments requested that FDA clarify the types of
State or local requirements for an audiological or medical evaluation,
prior to purchasing a prescription hearing aid, that this rule would
not preempt. Many of these comments conveyed uncertainty about the
effects on existing State and local requirements with the withdrawal of
previous exemption decisions that allowed States and localities to
establish and continue in effect requirements respecting hearing aids.
(Response) State or local requirements that were preempted solely
because they differed from or were in addition to the conditions for
sale requirements in Sec. 801.421 and for which FDA previously granted
exemptions from Federal preemption may continue in effect with respect
to prescription hearing aids after the withdrawal of the previous
exemption decisions. This is because State or local requirements are
preempted under section 521(a) of the FD&C Act only when FDA has
established specific counterpart regulations or there are other
specific requirements applicable to a particular device that make State
or local requirements applicable to the device different from, or in
addition to, the specific Federal requirements (see Sec. 808.1(d)).
The repeal of Sec. 801.421 will remove this specific counterpart
regulation that currently makes State or local requirements different
from, or in addition to, the specific Federal requirements therein. As
such, the State requirements that were preempted solely because they
differed from or were in addition to the requirements in Sec. 801.421
and for which FDA previously granted exemptions will no longer be
preempted under section 521(a) of the FD&C Act. They may therefore
continue in effect for prescription hearing aids, without an exemption,
so FDA is removing the exemption decisions that will become
unnecessary.
As a result, if a State establishes or continues in effect a
requirement that, for example, people younger than 18 must have a
medical evaluation by an ear-nose-throat doctor to obtain a
prescription hearing aid, then that requirement would, as a general
matter, no longer be ``different from, or in addition to,'' the
examination and waiver requirements in Sec. 801.421 that we are
repealing. Similarly, a State could establish or continue in effect a
requirement, for example, that a licensed hearing instrument specialist
refer an adult prescription hearing aid candidate for a medical
examination if the specialist observes a Red Flag condition. However, a
State could not establish or continue in effect such a referral
requirement for OTC hearing aids, as explained elsewhere in this
document.
Additionally, as explained elsewhere in this document, FDA is
revising the labeling requirements in Sec. 801.420 by, among other
things, moving them to new Sec. 801.422 and applying them to
prescription hearing aids. State or local requirements with respect to
prescription hearing aids that differ from, or are in addition to, the
requirements in Sec. 801.422 would be preempted under section 521(a)
of the FD&C Act.
I. Repeal of Restrictions and Modifications for Prescription Labeling
(Sec. Sec. 801.420, 801.421, 801.422)
Many comments related to repealing the conditions for sale for
hearing aids expressed concerns for maintaining the involvement of a
licensed person in the adoption and use of hearing aids. One result of
this rulemaking is that non-OTC air-conduction hearing aids will be
prescription hearing aids, which will require the order (prescription)
of a
[[Page 50741]]
practitioner licensed by State law, as we explain elsewhere in this
document. Thus, the repeal of Sec. 801.421 does not imply the removal
of a licensed person from hearing health care with respect to
prescription hearing aids.
Other comments communicated a desire for regulatory consistency
and/or continuity. While FDA would agree these are legitimate
interests, we generally declined to maintain the restrictions on those
bases. However, we note that final Sec. 801.422 retains many of the
labeling requirements under Sec. 801.420, and we have made the
labeling requirements for prescription hearing aids consistent with
that for OTC hearing aids to the extent appropriate.
(Comment 126) One comment expressed concern that with the repeal of
the hearing aid restrictions, the previous preemption decisions would
no longer apply. The comment stated that while many State laws that had
been denied an exemption have since been repealed, some unrepealed laws
that have been unenforceable would now be enforceable, including those
that would restrict and/or impede the sale of hearing aids.
(Response) FDA is repealing Sec. 801.421 which sets forth the
conditions for sale of hearing aids, and revising the labeling
requirements under Sec. 801.420 by, among other things, applying them
to prescription hearing aids only and moving them to new Sec. 801.422.
We assume that the comment is referring to the repeal of Sec. 801.421
given that the labeling requirements, although revised and moved to new
Sec. 801.422, would continue to exist and apply to prescription
hearing aids. FDA is repealing Sec. 801.421 because the Agency
believes these requirements are no longer necessary to provide
reasonable assurance of safety and effectiveness of prescription
hearing aids. FDA had been exercising enforcement discretion by
generally not enforcing most of the requirements in Sec. 801.421 since
late 2016. Additionally, we note that prescription hearing aids will
require a written or oral authorization from a practitioner licensed by
law to administer the device (see Sec. 801.109). This requirement,
along with the revised labeling requirements for prescription hearing
aids, will help provide reasonable assurance of safety and
effectiveness of these devices. State or local requirements that were
previously preempted under section 521 of the FD&C Act solely on the
basis that they were different from, or were in addition to, the
requirements in Sec. 801.421 would no longer be preempted as applied
to prescription hearing aids.
We note that State or local requirements would be preempted under
section 709(b)(4) of FDARA if they: specifically related to hearing
products; would restrict or interfere with the sale of, or other
commercial activity involving, OTC hearing aids; are different from, in
addition to, or otherwise not identical to, the OTC Hearing Aid
Controls; and do not fall within section 709(b)(5) of FDARA.
(Comment 127) Several comments proposed that prescription hearing
aids remain restricted devices. Many of these comments expressed
concerns about the role of licensed persons in fitting and dispensing
hearing aids, and a desire to ensure that prescription hearing aids
would only be sold pursuant to the written authorization of a qualified
hearing aid professional or, in some cases, a physician specifically.
Such comments, sometimes referring to ``special controls,'' also sought
to retain oversight of licensed persons.
(Response) Although FDA agrees that the selection and use of
prescription hearing aids should involve a licensed person, we are not
maintaining the device restrictions because the restrictions are
unnecessary to ensure the involvement of a licensed person in the use
of prescription hearing aids.
Under final Sec. 800.30(b), a prescription hearing aid is one that
does not meet the definition of ``over-the-counter hearing aid'' or
does not meet the requirements of the OTC Hearing Aid Controls. Any
hearing aid that is not OTC is a prescription device. A prescription
hearing aid is subject to Sec. 801.109 regarding prescription devices
(explained in the proposal, 86 FR 58150 at 58168). Among other
requirements, Sec. 801.109 specifies that prescription devices are
those to be sold only to or on the prescription or other order of a
practitioner licensed by law to use or order the use of the devices in
the course of professional practice (see Sec. 801.109(a)(2)). Further,
Sec. 801.109 requires labeling indicating that the device is only for
prescription use (see Sec. 801.109(b)(1)). A prescription hearing aid
that lacks this labeling would be misbranded (see final Sec.
801.422(c)(6)). Marketing a misbranded device, for example, by
introducing it into interstate commerce, and other activities with
respect to misbranded devices are prohibited acts (see, e.g., 21 U.S.C.
331(a)-(c), 331(k)).
FDA notes that, in some circumstances, requirements on prescription
hearing aids once this rule is in effect may be more stringent than
under former Sec. 801.421 which allowed a prospective hearing aid user
18 or older to waive the requirement for a medical evaluation (former
Sec. 801.421(a)(2)). Further, as we explained in the proposal, FDA had
expressed that we do not intend to enforce the medical evaluation,
waiver, or recordkeeping requirements with respect to prospective
purchasers who are 18 or older (see 86 FR 58150 at 58154). However,
once this rule repeals those restrictions, any hearing aid that meets
the definition of a prescription hearing aid will be subject to
requirements for prescription devices, such as those in Sec.
801.109(a)(2). That is, such devices may be sold only to or on the
prescription or other order of a licensed practitioner. We also note
that States, not FDA, generally determine the licensing requirements
for practitioners to use or order the use of a prescription device.
Thus, States may, for example, require that prescription hearing aids
be ordered by physicians (medical doctors) or audiologists, which may
involve a medical or audiological evaluation of the prospective user,
including someone who is 18 or older. (See also the response to Comment
128.)
(Comment 128) A few comments suggested that FDA apply device
restrictions to OTC hearing aids. A comment suggested that FDA make
both OTC and prescription hearing aids restricted devices. The comment
argued this would ensure regulatory consistency between categories as
well as supporting complementary State and local consumer protections.
(Response) FDA is declining to take these suggestions. We are not
making OTC hearing aids restricted devices under section 520(e) of the
FD&C Act, and we are repealing the existing restrictions on hearing
aids. For OTC and prescription hearing aids, at this time we believe
the authorities that we are relying on, including those described in
section IV of this document, are adequate. Because we are not relying
on our restricted device authority at this time, neither OTC hearing
aids nor prescription hearing aids would be restricted devices under
section 520(e) of the FD&C Act. Therefore, there would be regulatory
consistency between these categories in this respect.
Further, to the extent the comment is requesting that FDA maintain
the restrictions in Sec. 801.421, the restrictions that we are
repealing do not in themselves enable or support complementary State
and local consumer protections. Indeed, many of the State requirements
for hearing aids for which FDA had granted exemptions from Federal
preemption were
[[Page 50742]]
preempted because of the restrictions (they were different from, or
were in addition to, the restrictions), and the State requirements
continued in effect because the States applied for, and FDA granted,
exemptions. Absent the restrictions, those State requirements, many of
which related to patient or consumer protection, likely would not have
been preempted (all else being equal) and could have continued in
effect without FDA acting to exempt them.
Moreover, section 709(b)(4) of FDARA would continue to apply to OTC
hearing aids and, as described elsewhere, would still preempt certain
State and local requirements pertaining to a wide range of commercial
activity involving OTC hearing aids, regardless of whether or not OTC
hearing aids are restricted devices. Additionally, FDA would not expect
that making OTC hearing aids restricted devices would augment State and
local consumer protections that would continue in effect. (See also the
response to Comment 127.)
(Comment 129) Some comments proposed that prescription hearing aids
remain restricted devices to ensure that FDA retain the added
regulatory authority over advertising material for restricted devices.
These comments asserted that advertising has falsely or misleadingly
suggested that products were hearing aids, inducing people to use
products that were not safe or effective options to address or
compensate for hearing loss. The use of unsafe or ineffective products,
instead of hearing aids, has an increased risk of impairing the user's
remaining hearing or convincing users not to seek safer, more effective
options.
(Response) FDA is not accepting this proposal because as explained
in the response above, at this time we believe the authorities that we
are relying on, including those described in section IV of this
document, are adequate.
Additionally, restricted device authority is not necessary for FDA
regulation of products that are marketed as hearing aids but do not
comply with applicable requirements. The intended use of an article
(not just restricted devices) may be shown by, among other indicia, the
circumstances surrounding distribution as well as advertising matter
(see Sec. 801.4). Should such circumstances or advertising show that
the article is intended to compensate for hearing loss, then it would
be subject to labeling and other requirements for hearing aids. Failure
to meet these requirements would render the article adulterated and/or
misbranded (see 21 U.S.C. 351 and 352). Marketing (for example, by
introducing such articles into interstate commerce) and other
activities with respect to such articles would constitute prohibited
acts even though prescription hearing aids would not be restricted
devices (see, e.g., 21 U.S.C. 331(a)-(c), 331(k)).
(Additional Revision 5) FDA has identified additional revisions
that would provide for clarity and consistency upon the removal of
Sec. 801.420 and the repeal of Sec. 801.421. We proposed to amend
Sec. 874.3950 (21 CFR 874.3950), the classification regulation for
transcutaneous air-conduction hearing aid systems, by specifying that
the devices would be subject to new Sec. 801.422. This would clarify
that the devices are prescription hearing aids and subject to
corresponding labeling requirements.
However, the regulation currently specifies that transcutaneous
air-conduction hearing aid systems are subject to special controls
described by the document, ``Class II Special Controls Guidance
Document: Transcutaneous Air Conduction Hearing Aid System (TACHAS);
Guidance for Industry and FDA,'' issued on November 7, 2002 (see Sec.
874.3950(b)).\16\ That document in turn currently refers to Sec. Sec.
801.420 and 801.421. Further, in reviewing the document for consistency
with this rulemaking, we observed that its Scope section refers
incorrectly to Sec. 874.3340, which is not the correct citation for
the classification regulation for transcutaneous air-conduction hearing
aid systems.
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\16\ The document is available online at: https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/transcutaneous-air-conduction-hearing-aid-system-tachas-class-ii-special-controls-guidance-document.
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For clarity and consistency, in addition to the amendment that we
proposed to Sec. 874.3950(a), we are revising the special controls
document by replacing references to Sec. Sec. 801.420 and 801.421 with
Sec. 801.422 for both. We also are correcting the reference to the
incorrect classification regulation to the correct one, which is Sec.
874.3950. To indicate these revisions, we are adding a statement to the
special controls document that we revised the document. We will publish
the special controls document with the revisions on or around the
effective date of this final rule. However, we are not revising the
substance of the special controls document, and as such, we are not
updating the date on which the document was issued. The revisions to
the special controls document will appear on FDA's website.
J. Other Amendments
(Comment 130) One comment suggested that FDA include a misbranding
provision for OTC hearing aids with respect to labeling, similar to the
provision included for prescription hearing aids (final Sec.
801.422(c)(6)).
(Response) FDA declines to include a similar misbranding provision
for OTC hearing aids under Sec. 800.30. As provided in Sec. Sec.
800.30(a) and (b) and 801.422(a) and (b), any hearing aid that does not
satisfy the requirements of Sec. 800.30, including the labeling
requirements of that section, is a prescription hearing aid, and as
such, must meet the requirements of Sec. Sec. 801.422 and 801.109. In
other words, a hearing aid that fails to meet the labeling requirements
of Sec. 800.30 would be subject to Sec. Sec. 801.422 and 801.109. In
turn, failure to meet the labeling requirements of Sec. Sec.
801.422(c) and 801.109 would render the product misbranded, as stated
in final Sec. 801.422(c)(6). In other words, hearing aids that fail to
comply with the requirements in Sec. 800.30 would be prescription
hearing aids and would be misbranded if they fail to comply with
Sec. Sec. 801.422 and 801.109. For example, such a hearing aid would
be misbranded under section 502(f)(1) of the FD&C Act in that its
labeling would fail to bear adequate directions for use and it would
not be exempt from this requirement.
(Comment 131) A comment proposed that FDA develop a national
standard to sell prescription hearing aids via telemedicine visits with
licensed persons to people who are 18 years of age or older. The
comment suggested that the standard could include calibrated in-home
tests for both air-conduction and bone-conduction devices.
(Response) Although FDA establishes performance standards for
devices, among other general and special controls, in appropriate
circumstances, FDA does not generally establish standards for medical
practice, including telemedicine. However, we note that in-home hearing
tests may meet the definition of ``device'' and be subject to the
provisions of, and regulatory controls under, the FD&C Act, including
those described in section IV of this document. Classification of a
hearing test would establish the controls necessary to provide
reasonable assurance of safety and effectiveness of the device for its
intended use(s), and these would apply to the devices nationally. (See
also section X describing the implications of federalism.)
[[Page 50743]]
(Additional Revision 6) FDA has decided not to realign the
classification regulations by sound conduction mode as proposed.
Combining the existing regulations may have suggested to stakeholders
that only a single device type was appropriate for OTC availability or
vice versa. However, as explained elsewhere, for example, in the
response to Comment 2, that is not the case. To reduce the potential
for this kind of confusion, we are keeping the various air-conduction
generic types in their existing regulations. However, we are proceeding
to separate bone-conduction hearing aids into their own classification
regulation, new Sec. 874.3302, including the reassignment of product
codes. We are also proceeding with the other proposed minor revisions
to the air-conduction classification regulations, including the
revisions to the special controls as provided in proposed Sec.
874.3305(b) and clarifying the applicability of requirements under
either final Sec. 800.30 or Sec. 801.422 for the various generic
types.
VI. Effective and Compliance Dates
(Comment 132) FDA received several comments proposing that the
compliance date be the same for hearing aids that have and have not
been offered for sale prior to the effective date of this final rule.
These comments provided various reasons, including that: new entrants
into the hearing aid market need time to make pre-launch adjustments to
their marketing and devices they plan to introduce and need more than
the 60 days proposed; that FDA takes longer than 60 days to review
510(k)s; and that different compliance dates for different
manufacturers would be unfair. Most such comments proposed a compliance
date of 240 days after the publication of this final rule.
(Response) FDA is not establishing the same compliance dates
because hearing aids that are not offered for sale, that is, not on the
market, are not similarly situated as hearing aids offered for sale,
that is, on the market, prior to the effective date. The compliance
date is not the date by which new entrants must start marketing, and if
new entrants find they need additional time prior to marketing their
devices, they may take it. Moreover, should a new entrant need to
obtain 510(k) clearance, it could not market the device until it
obtains clearance, regardless of the compliance date.
We acknowledge that hearing aids on the market will have a
different timeframe for compliance. However, the consequences of
noncompliance with the new requirements are different for hearing aids
that are on the market from those not on the market when this rule
takes effect. For hearing aids that are on the market, they are subject
to enforcement actions if they do not comply with the new requirements
as well as other applicable requirements. Given this, they need
sufficient time to come into compliance. Hearing aids that are not on
the market do not face these consequences--as discussed above, if such
hearing aids do not comply with the new requirements and other
applicable requirements, manufacturers may take whatever time they need
to bring the devices into compliance. As such, the same compliance
timeframe is not appropriate in this case. See the response to Comment
133 about considerations for 510(k)s for marketed devices.
(Comment 133) Some comments regarding marketed devices also raised
concerns that FDA may take too long to review 510(k)s, and devices
could be out of compliance even if a manufacturer submitted a 510(k)
soon after the publication of this final rule. They sought
clarification and/or a change in the compliance date.
(Response) In consideration of the comments, for hearing aids
legally offered for sale prior to the effective date, FDA intends not
to enforce the requirement for a 510(k) in certain situations, as
discussed in the compliance date section below.
(Comment 134) Some comments questioned how soon hearing aids could
be made available OTC, including whether manufacturers would need to
wait 60 days (until the effective date).
(Response) Generally, hearing aids could not be available OTC
within the meaning of section 520(q)(1)(A)(v) of the FD&C Act until the
effective date of this final rule.
A. Effective Date
This final rule will be effective 60 days after the publication in
the Federal Register. We are finalizing the following compliance dates:
B. Compliance Date for Hearing Aids Not Legally Offered for Sale Prior
to the Effective Date
For hearing aids that have not been offered for sale prior to the
effective date of the final rule, or have been offered for sale but are
required to submit a new 510(k) under Sec. 807.81(a)(3) due to changes
unrelated to this rule (an example of such is the addition of self-
fitting technology to a wireless air-conduction hearing aid),
compliance with the new or revised requirements applicable to the
hearing aid, and obtaining 510(k) clearance if applicable, must be
achieved before marketing the device on or after the effective date of
this final rule. If a person (e.g., manufacturer) markets such a device
without complying with the new or revised requirements or if
applicable, obtaining 510(k) clearance, then FDA would consider taking
action against such person under our usual enforcement policies.
C. Compliance Date for Hearing Aids Legally Offered for Sale Prior to
the Effective Date
For hearing aids that have been legally offered for sale prior to
the effective date of the final rule, including those that already have
a 510(k) clearance, compliance with the new or revised requirements
that apply to the hearing aid must be achieved 180 days after the
effective date of the final rule (i.e., 240 days after the publication
of the final rule). After that date, if a person (e.g., manufacturer)
continues to market such a device but does not comply with the new or
revised requirements that apply to the device, then FDA would consider
taking action against such person under our usual enforcement policies.
However, FDA does not intend to enforce the requirement to submit a
510(k) and obtain 510(k) clearance where a hearing aid is legally
offered for sale prior to the effective date; the changes that require
a new 510(k) are made on or before the compliance date and are made
solely to satisfy the OTC Hearing Aid Controls; the changes do not
adversely affect device safety or effectiveness; the device is
otherwise in compliance with applicable requirements; and on or before
the compliance date, the manufacturer documents the changes and its
determination that the changes do not adversely affect device safety or
effectiveness.
At present, legacy and wireless air-conduction hearing aids are
exempt from section 510(k) (21 U.S.C. 360(k)) of the FD&C Act, subject
to the limitations of exemption described in Sec. 874.9. (Legacy
hearing aids are class I devices and are 510(k) exempt under section
510(l)(1) of the FD&C Act.) See the response to Comment 5 for more
about considerations for when to submit a 510(k).
VII. Economic Analysis of Impacts
We have examined the impacts of this final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct us to assess all
[[Page 50744]]
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). This rule is an economically significant regulatory action as
defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because the estimated annualized cost over 10 years is $0.009
million per firm, which is unlikely to represent more than three
percent to five percent of the revenue of an affected manufacturer, we
certify that this final rule will not have a significant economic
impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $165 million, using the most current (2021) Implicit
Price Deflator for the Gross Domestic Product. This final rule will
result in an expenditure in at least one year that meets or exceeds
this amount.
This rule defines a new regulatory category for OTC hearing aids
and makes corresponding changes to the existing regulatory framework,
including defining hearing aids not meeting the OTC requirements as
prescription medical devices, as well as providing new labeling
requirements for both OTC and prescription hearing aids. This rule
would generate potential cost savings for consumers with perceived mild
to moderate hearing impairment who wish to buy lower cost hearing aids
not bundled with professional services and not requiring professional
advice, fitting, adjustment, or maintenance but who are currently
unable to buy such products online because of State regulations or
because they do not shop online. This rules also generates costs for
hearing aid manufacturers for changing labeling of existing hearing
aids as well as for reading the rule and revising internal standard
operating procedures in response to the rule. Table 1 summarizes our
estimate of the annualized costs and the annualized benefits of this
final rule.
Table 1--Summary of Benefits, Costs and Distributional Effects of Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
Units
------------------------------------
Category Primary Low High Period Notes
estimate estimate estimate Year Discount covered
dollars rate (%) (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
Annualized Monetized $millions/year....... $63 $6 $147 2020 7 10 ................................
63 6 147 2020 3 10
Annualized Quantified..................... .......... .......... .......... .......... 7 .......... ................................
3
---------------------------------------------------------------------------------------------------------
Qualitative............................... Potential increase in hearing aid .......... .......... .......... ................................
and hearing technology use,
leading to associated health
benefits, potential fostering of
innovation in hearing aid
technology. Potential increase in
consumer utility, derived from
reduced health risks, from
inability to buy some existing
hearing aids under existing
conditions.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
Annualized Monetized $millions/year....... 1 1 2 2020 7 10 ................................
1 1 2 2020 3 10
Annualized Quantified..................... .......... .......... .......... .......... 7 .......... ................................
3
---------------------------------------------------------------------------------------------------------
Qualitative............................... Potential loss of consumer utility .......... .......... .......... ................................
from inability to buy existing
hearing aids under existing
conditions, including consumers of
online hearing aids that do not
meet OTC requirements. Costs to
manufacturers of hearing aids sold
online that do not meet OTC
requirements to render their
products and sales methods
consistent with the requirements
of either OTC or prescription
hearing aids.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
Federal Annualized Monetized $millions/ .......... .......... .......... .......... 7 .......... ................................
year. 3
---------------------------------------------------------------------------------------------------------
From/To................................... From:
To: ..........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Other Annualized Monetized $millions/year. .......... .......... .......... .......... 7 .......... ................................
3
---------------------------------------------------------------------------------------------------------
From/To................................... From:
To: ..........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
State, Local or Tribal Government:..................................................................................................................
Small Business:.....................................................................................................................................
[[Page 50745]]
Wages:..............................................................................................................................................
Growth:.............................................................................................................................................
Distributional effects are also possible that would favor general retailers and new manufacturers entering into the hearing aid market who do not
have relations with current specialty retail suppliers and disfavor specialty retail suppliers and associated workers including hearing healthcare
professionals, and established manufacturers with relations with those suppliers..
--------------------------------------------------------------------------------------------------------------------------------------------------------
We have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of this rule. The full analysis of economic
impacts is available in the docket for this rule (Ref. 16) and at
https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.
VIII. Analysis of Environmental Impact
FDA has carefully considered the potential environmental impact of
this final rule and of possible alternative actions. In doing so, the
Agency focused on the environmental impacts of its action as a result
of increased use and eventual disposal of OTC hearing aids that will
need to be handled after the effective date of this final rule.
The environmental assessment (EA) considers environmental impacts
related to additional waste to landfills at municipal solid waste (MSW)
facilities. The selected action will likely increase the availability
and use of hearing aid devices, which would result in additional waste
from increased disposal of these devices and their associated
batteries, as well as an increase in industrial waste associated with
any domestic production to meet market demand for the new devices.
Overall, given the current limited use of these devices, projected slow
growth with increase in availability, and the small mass of waste
material to be disposed or recycled, the selected action is not
expected to have a significant impact on MSW, landfill facilities, and
the environment.
The Agency has concluded that the final rule will not have a
significant impact on the human environment, and that an environmental
impact statement is not required. FDA's FONSI and the evidence
supporting that finding, contained in an EA prepared under 21 CFR
25.40, are on display with the Dockets Management Staff (see ADDRESSES)
and are available for viewing by interested persons between 9 a.m. and
4 p.m., Monday through Friday; they are also available electronically
at https://www.regulations.gov.
IX. Paperwork Reduction Act of 1995
This final rule contains information collection provisions that are
subject to review by OMB under the PRA (44 U.S.C. 3501-3521). The
title, description, and respondent description of the information
collection provisions are shown in the following paragraphs with an
estimate of the annual reporting, recordkeeping, and third-party
disclosure burden. Included in the estimate is the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing each
collection of information.
Title: Medical Device Labeling Regulations; OMB Control Number
0910-0485--Revision.
Description: FDA is establishing a regulatory category for OTC
hearing aids and making related amendments to update the regulatory
framework for hearing aids. Among other amendments described in this
rulemaking, we amend the existing labeling requirements for hearing
aids. In creating a regulatory category for OTC hearing aids and
amending existing rules, we intend to provide reasonable assurance of
safety and effectiveness for hearing aids as well as foster access to,
and innovation in, hearing aid technology, thereby protecting and
promoting the public health.
Description of Respondents: Respondents to the information
collection are manufacturers of hearing aids.
We estimate the burden of the collection of information as follows:
Table 2--Estimated One-Time Burden \1\ \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average
Activity Number of records per Total annual burden per Total hours Total capital
recordkeepers recordkeeper records recordkeeping costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Understanding and implementing new regulatory 105 1 105 290 30,450 $4,100,000
requirements from hearing aids rule....................
Hearing aids relabeling................................. 105 8 840 68 57,120 6,000,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded to the nearest whole number.
Table 3--Estimated Annual Recordkeeping Burden \1\ \2\
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity; 21 CFR section Number of records per Total annual burden per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Labeling disclosures under 105 8 840 1 840
800.30(c)(2) and 801.422(c)(2);
Hearing aids; electronic
version of user instructional
brochure.......................
----------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded to the nearest whole number.
[[Page 50746]]
Table 4--Estimated Annual Third-Party Disclosure Burden \1\ \2\
----------------------------------------------------------------------------------------------------------------
Number of
Number of disclosures Total annual Average
Activity; 21 CFR section respondents per disclosures burden per Total hours
respondent disclosure
----------------------------------------------------------------------------------------------------------------
OTC Hearing Aid Controls--800.30 105 7 735 19 13,965
Prescription Hearing Aid 105 1 105 19 1,995
Labeling--801.422..............
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 15,960
----------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded to the nearest whole number.
Our burden estimate is based on FDA Uniform Registration and
Listing System data; FDA's Operational and Administrative System for
Import Support data; informal communications with industry; and our
knowledge of and experience with information collection pertaining to
medical device labeling. We intend the burden estimates to be
consistent with our Final Regulatory Impact Analysis (FRIA) for this
rulemaking (Ref. 16).
Estimated One-Time Burden: Understanding and implementing new
regulatory requirements from hearing aids rule--one-time burden
(Recordkeeping): As noted in the FRIA for this rulemaking, we estimate
it will take 5 hours each for an executive, a lawyer, and a marketing
manager to read and understand the rule. Also included in our estimate
is time for revising guidelines or standard operating procedures. We
assume this may take up to 25 hours for one executive, up to 100 hours
for one marketing manager, and up to 150 hours for one technical
writer. Therefore, we estimate a one-time recordkeeping burden of 290
hours for each manufacturer.
Hearing aids relabeling--one-time burden (Third-Party Disclosure):
The rulemaking necessitates the relabeling of all current hearing aids
(approximately 840). The labeling cost model used in the FRIA suggests,
based on a compliance date 240 days after publication of the final
rule, a one-time estimated third-party disclosure burden for relabeling
of about 68 hours per product.
Estimated Annual Burden: Over-the-Counter Hearing Aid Controls--
Sec. 800.30 (Recordkeeping and Third-Party Disclosure): Section 800.30
sets forth labeling requirements for OTC hearing aids. Section
800.30(c)(1) describes the warnings and other important information
that the outside package must bear. Manufacturers must include on the
outside package label: certain specified warnings and statements; a
weblink to all labeling and any additional resources; contact
information to request a paper copy of the labeling; their return
policy or absence thereof; if the OTC hearing aid is used or rebuilt,
they must declare that fact; the principal display panel must bear the
marks ``OTC'' and ``hearing aid''; battery information; and control
platform information if applicable.
Section 800.30(c)(2) describes device-specific requirements for
labeling, inside the package. Among the labeling requirements listed
are a user instructional brochure, an electronic version of which is to
be made available for download; additional warnings; caution and
notices for users; other specified information; and any other
information necessary for adequate directions for use as defined in
Sec. 801.5. Also required under proposed Sec. 800.30(c)(2) is the
identification of any known physiological side effects associated with
the use of the OTC hearing aid that may warrant consultation with a
physician; the technical specifications required by Sec. 800.30(c)(4);
a description of commonly occurring, avoidable events that could
adversely affect or damage the OTC hearing aid; if applicable,
information relating to electromagnetic compatibility and wireless
technology and human exposure to non-ionizing radiation; information
regarding repair service or replacements; and, if applicable, a summary
of all clinical or non-clinical studies conducted to support the
performance of the OTC hearing aid.
Section 800.30(c)(3) provides requirements for the labeling on an
OTC hearing aid itself, specifically, serial number, information
regarding the battery and, if the OTC hearing aid is used or rebuilt,
the manufacturer must physically attach a removable tag to the hearing
aid declaring that fact.
Section 800.30(c)(5) provides requirements related to software
device labeling.
We include no estimate for provisions under proposed Sec.
800.30(c)(1)(i)(A) through (D), (c)(2)(i)(A) through (C), and
(c)(2)(iii)(A) through (F) because we consider the labeling to be
``public disclosure of information originally supplied by the Federal
government to the recipient for the purpose of disclosure to the
public,'' consistent with 5 CFR 1320.3(c)(2). Thus, those labeling
provisions are not within the definition of collection of information.
The FRIA for this rulemaking estimates that 105 firms manufacture
air-conduction hearing aids sold in the United States, based on FDA
Medical Device Registration data. We estimate that each manufacturer
has an average of eight products that would need relabeling.
For each hearing aid product, we assume a 1-hour annual
recordkeeping burden for maintaining the electronic version of the user
instructional brochure (under Sec. Sec. 800.30(c)(2) and
801.422(c)(2)).
The rulemaking would necessitate the relabeling of all current
hearing aids (approximately 840) according to either the OTC or
prescription hearing aid labeling requirements. While we lack specific
data regarding what portion of hearing aids will be relabeled as
prescription devices and what portion will be relabeled as OTC hearing
aids, for this analysis, we assume that 10 percent will be relabeled as
prescription medical devices (about 1 product per manufacturer) and 90
percent as OTC hearing aids (about 7 products per manufacturer). The
labeling cost model used in the FRIA suggests an annual estimated
third-party disclosure burden of about 19 hours per product.
Prescription Hearing Aid Labeling--Sec. 801.422 (Third-Party
Disclosure): Section 801.422(c) sets forth labeling requirements for
prescription hearing aids. However, as with some of the provisions
under proposed Sec. 800.30(c), we include no estimate for provisions
under Sec. 801.422(c)(1)(i)(A) through (C), (c)(2)(i)(A) through (C),
and (c)(2)(ii)(A) through (F) because we consider the labeling to be
``public disclosure of information originally supplied by the Federal
government to the recipient for the purpose of disclosure to the
public,'' consistent with 5 CFR 1320.3(c)(2).
Section 801.422(c)(1) provides the warnings and notice that must be
on the
[[Page 50747]]
outside package labeling; if applicable, that the prescription hearing
aid is used or rebuilt; battery information; and if applicable, control
platform information.
Section 801.422(c)(2) describes requirements for prescription
hearing aid labeling, inside the package. Among the labeling
requirements listed are a user instructional brochure, an electronic
version of which is to be made available for download; warnings;
caution and notices for users; and additional information that must be
included in the user instructional brochure.
Section 801.422(c)(3) provides the requirements for the labeling on
a prescription hearing aid itself, specifically, serial number;
information regarding the battery if applicable; and if the
prescription hearing aid is used or rebuilt, the manufacturer must
physically attach a removable tag to the hearing aid declaring that
fact.
Section 801.422(c)(4) provides the technical specification elements
that must appear in the user instructional brochure or in separate
labeling that accompanies the device.
Section 801.422(c)(5) provides requirements related to software
device labeling.
The FRIA estimates that 105 firms manufacture air-conduction
hearing aids sold in the United States, based on FDA Medical Device
Registration data. We estimate that each manufacturer has an average of
eight products that would need relabeling.
For each hearing aid product, we assume a 1-hour annual
recordkeeping burden for maintaining the electronic version of the user
instructional brochure (under Sec. Sec. 800.30(c)(2) and
801.422(c)(2)).
The rulemaking would necessitate the relabeling of all current
hearing aids (approximately 840) according to either the OTC or
prescription hearing aid labeling requirements. While we lack specific
data regarding what portion of hearing aids will be relabeled as
prescription devices and what portion will be relabeled as OTC hearing
aids, for this analysis, we assume that 10 percent will be relabeled as
prescription medical devices (about 1 product per manufacturer) and 90
percent as OTC hearing aids (about 7 products per manufacturer). The
labeling cost model used in the FRIA suggests an annual estimated
third-party disclosure burden of about 19 hours per product.
As required by section 3506(c)(2)(B) of the PRA, FDA provided an
opportunity for public comment on the information collection
requirements of the proposed rule.
We received more than 1,000 comments on the proposed rule. We
describe and respond to the comments in section V of this document,
``Comments on the Proposed Rule and FDA's Responses.'' Comments and
responses related to the provisions that underlie the information
collection are described in the following sections: III.B, regarding
scope; III.D, regarding labeling; and III.F, regarding other device
requirements. We have not made changes to the estimated burden as a
result of those comments.
We also received a comment relating to the information collection
burden estimate. The comment expressed concern that, for a small
business, the ``cost for building a system from scratch'' and for
reading and understanding the rule, without a lawyer or a marketing
manager, is overly burdensome.
Included in our estimate of 290 hours for ``Understanding and
implementing new regulatory requirements from hearing aids rule,'' is
an average of 5 hours each for an executive, a lawyer, and a marketing
manager to read and understand the rule. Therefore, we estimate 15
hours for reading and understanding the rule. We assume that a
manufacturer who does not employ a lawyer or marketing manager, would
take approximately the same amount of time to read and understand the
rule. This is consistent with the comment's statement that it took ``at
least 8 hours to read through and understand this rule.''
While it is not clear what is meant by ``building a system from
scratch'' in this context, included in our estimate is time for
revising guidelines or standard operating procedures. We assume this
may take up to 25 hours for one executive, up to 100 hours for one
marketing manager, and up to 150 hours for one technical writer; a
total of 275 hours for revising guidelines or standard operating
procedures. Our estimate assumes that, as a standard business practice
and in compliance with the existing requirements, a company has
guidelines or standard operating procedures in place and that the
burden estimate represents only the time to revise existing
documentation to be consistent with the rulemaking. We believe this
estimate reflects an appropriate amount of time for understanding and
implementing the new regulatory requirements.
Additionally, the comment expressed concern about the time to write
``the user instructional brochure from scratch.''
We have included a 68-hour, one-time burden estimate for the
relabeling necessitated by the rulemaking. This estimate includes,
among other things, time for updating the user instructional brochure
and providing the required content online. Our recordkeeping burden
estimate of 1 hour for ``Labeling disclosures under Sec. Sec.
800.30(c)(2) and 801.422(c)(2); Hearing aids; electronic version of
user instructional brochure'' is an annual estimate, intended to
reflect the maintenance of records associated with the requirement in
Sec. Sec. 800.30(c)(2) and 801.422(c)(2) to make an electronic version
of a user instructional brochure available for download.
We have not revised our burden estimate based on this comment.
The information collection provisions in this final rule have been
submitted to OMB for review as required by section 3507(d) of the
Paperwork Reduction Act of 1995.
Before the effective date of this final rule, FDA will publish a
notice in the Federal Register announcing OMB's decision to approve,
modify, or disapprove the information collection provisions in this
final rule. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number.
X. Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. Section 4(a) of the Executive order
requires Agencies to ``construe . . . a Federal statute to preempt
State law only where the statute contains an express preemption
provision or where there is some other clear evidence that the Congress
intended preemption of State law, or where the exercise of State
authority conflicts with the exercise of Federal authority under the
Federal statute.'' Federal law includes an express preemption provision
that preempts certain State requirements ``different from, or in
addition to, any requirement applicable under'' the FD&C Act that is
applicable to devices. (See section 521 of the FD&C Act; Medtronic v.
Lohr, 518 U.S. 470 (1996); and Riegel v. Medtronic, 552 U.S. 312
(2008).) Federal law also preempts State or local laws ``specifically
related to hearing products that would restrict or interfere with the
servicing, marketing, sale, dispensing, use, customer support, or
distribution of [OTC hearing aids] through in-person transactions, by
mail, or online, that [are] different from, in addition to, or
otherwise not identical to, the regulations promulgated under'' section
[[Page 50748]]
709(b) of FDARA (see section 709(b)(4) of FDARA).
Section 521(b) of the FD&C Act provides that the Commissioner of
Food and Drugs may, upon application of a State or local government,
exempt a requirement from preemption, if the State or local requirement
for the device is more stringent than the requirement under the FD&C
Act, or if the requirement is necessitated by compelling local
conditions and compliance with it would not cause the device to be in
violation of a requirement under the FD&C Act. Following this process,
a State or local government may request an exemption from preemption
for those State or local requirements pertaining to hearing aid
products that are preempted by the Agency's final rule under section
521 of the FD&C Act. However, because FDARA does not provide a parallel
mechanism to exempt State or local requirements from its express
preemption provision, FDA is not considering exemptions under section
709(b)(4) of FDARA for OTC hearing aids.
Thus, this final rule will create requirements that fall within the
scope of section 521 of the FD&C Act and/or section 709(b)(4) of FDARA.
It also amends Sec. 801.420 and repeals Sec. 801.421, and such
changes affect many of the decisions on applications for exemption from
preemption that were issued in relation to these two regulations under
section 521(b) of the FD&C Act, resulting in the removal of the
regulations codifying such decisions, as discussed further in section
V.I. above. The scope of preemption of this final rule is discussed in
more detail in sections III.G through I, above.
XI. Consultation and Coordination With Indian Tribal Governments
We have analyzed this rule in accordance with the principles set
forth in Executive Order 13175. We have determined that the rule does
not contain policies that would have a substantial direct effect on one
or more Indian Tribes, on the relationship between the Federal
Government and Indian Tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian Tribes.
Accordingly, we conclude that the rule does not contain policies that
have tribal implications as defined in the Executive order and,
consequently, a tribal summary impact statement is not required.
XII. References
The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they are also available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only with the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.
1. Lin, F., J. Niparko, and L. Ferruci, ``Hearing Loss Prevalence in
the United States.'' Archive of Internal Medicine, 171:1851-1853,
2011.
2. Dalton, D.S., ``The Impact of Hearing Loss on Quality of Life in
Older Adults.'' The Gerontologist, 43(5):661-668, 2005.
*3. National Institutes of Health (NIH). Hearing Aids Fact Sheet.
National Institute on Deafness and Communication Disorders. 2010.
Available at: https://www.nidcd.nih.gov/health/statistics/quick-statistics-hearing.
4. Maharani, A., P. Dawes, et al., ``Longitudinal Relationship
Between Hearing Aid Use and Cognitive Function in Older Americans.''
Journal of the American Geriatrics Society, 66(6):1130-1136, 2018.
5. Mahmoudi, E., T. Basu, et al., ``Can Hearing Aids Delay Time to
Diagnosis of Dementia, Depression, or Falls in Older Americans?''
Journal of the American Geriatrics Society, 67(11):2362-2369, 2019.
6. McCormack, A. and H. Fortnum, ``Why Do People Fitted With Hearing
Aids Not Wear Them?'' International Journal of Audiology, 52(5):360-
368, 2013.
7. NASEM, ``Hearing Health Care for Adults: Priorities for Improving
Access and Affordability.'' Board on Health Sciences Policy,
Committee on Accessible and Affordable Hearing Health Care for
Adults; Blazer, D.G., S. Domnitz, and C.T. Liverman, Eds., 2016.
DOI: 10.17226/23446. Available at: https://www.nap.edu/catalog/23446/hearing-health-care-for-adults-priorities-for-improving-access-and.
8. ANSI/CTA 2051: Personal Sound Amplification Performance Criteria
(voluntary consensus standard). January 2017. Available at: https://webstore.ansi.org/standards/ansi/cta20512017ansi.
*9. NIOSH, Occupational Noise Exposure, publication number 98-126.
June 1998. Available at: https://www.cdc.gov/niosh/docs/98-126/pdfs/98-126.pdf.
10. Johnson, E.E., ``Safety Limit Warning Levels for the Avoidance
of Excessive Sound Amplification to Protect Against Further Hearing
Loss.'' International Journal of Audiology, 56(11):829-836, 2017.
11. Tedeschi, T., C. Jones, and E. Stewart. ``Real World Evidence on
Gain and Output Settings for Individuals with Mild-to-Moderate
Hearing Loss.'' Hearing Review, 27(7):9-11, 2020.
12. Ahmad, I., W.C. Lee, and J.D. Binnington. ``External Auditory
Canal Measurements: Localization of the Isthmus.''
Otorhinolaryngologia Nova, 10:183-186, 2000.
13. Grewe, J., C. Thiele, et al. ``New HRCT-Based Measurement of the
Human Outer Ear Canal as a Basis for Acoustical Methods.'' American
Journal of Audiology, 22:65-73, 2013.
14. NASEM, ``Over-The-Counter Hearing Devices Discussion: Safety and
Quality Requirements and Considerations Session.'' MP3, 1:15:39
(English). National Academies' Hearing Health Care Report: June 2017
Dissemination Meeting; Washington, DC, 2017.
*15. FDA, ``Streamlining Good Manufacturing Practices (GMPs) for
Hearing Aids,'' public workshop. Silver Spring, MD; April 21, 2016.
Available at: https://wayback.archive-it.org/7993/20171114234227/https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm480336.htm.
*16. FDA, ``Regulatory Impact Analysis; Regulatory Flexbility
Analysis; Unfunded Mandates Reform Act Analysis.'' 2022. Available
at: https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
List of Subjects
21 CFR Part 800
Administrative practice and procedure, Medical devices, Ophthalmic
goods and services, Packaging and containers, Reporting and
recordkeeping requirements.
21 CFR Part 801
Labeling, Medical devices, Reporting and recordkeeping
requirements.
21 CFR Part 808
Intergovernmental relations, Medical devices.
21 CFR Part 874
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, 21 CFR
parts 800, 801, 808, and 874 are amended as follows:
PART 800--GENERAL
0
1. The authority citation for part 800 is revised to read as follows:
Authority: 21 U.S.C. 321, 334, 351, 352, 355, 360e, 360i, 360j,
360k, 361, 362, 371.
Section 800.30 also issued under Sec. 709, Pub. L. 115-52, 131
Stat. 1065-67.
0
2. Add Sec. 800.30 to subpart B to read as follows:
[[Page 50749]]
Sec. 800.30 Over-the-counter hearing aid controls.
(a) Scope. This section specifies the requirements for over-the-
counter (OTC) air-conduction hearing aids. Air-conduction hearing aids
that satisfy the requirements in paragraphs (c) through (f) of this
section are considered ``available'' over the counter as section
520(q)(1)(A)(v) of the Federal Food, Drug, and Cosmetic Act uses the
term. Air-conduction hearing aids that do not meet the definition in
section 520(q) of the Federal Food, Drug, and Cosmetic Act or do not
satisfy the following requirements are prescription hearing aids.
Unless otherwise specified, the requirements in this section are in
addition to other applicable requirements, including but not limited to
special controls found in the applicable classification regulation in
part 874 of this chapter.
(b) Definitions for the purposes of this section. This section uses
the following definitions:
Air-conduction hearing aid. An air-conduction hearing aid is a
hearing aid that conducts sound to the ear through the air.
Hearing aid. A hearing aid is any wearable device designed for,
offered for the purpose of, or represented as aiding persons with or
compensating for, impaired hearing.
Licensed person. A licensed person is a person as defined in
section 201(e) of the Federal Food, Drug, and Cosmetic Act that holds a
license or degree for the diagnosis, assessment, or treatment of
hearing loss; or that holds a license to sell or distribute hearing
aids. A person that must meet generally applicable licensing or
operating requirements such as annual health and safety inspections,
provided the generally applicable licensing or operating requirement is
consistent with this section and other applicable requirements under
the Federal Food, Drug, and Cosmetic Act, is not a ``licensed person''
solely for that reason. A person that represents as a marketer, seller,
dispenser, distributor, or customer support representative (or an
equivalent description) is not a ``licensed person'' solely by making
such representations.
Over-the-counter hearing aid. An over-the-counter (OTC) hearing aid
is an air-conduction hearing aid that does not require implantation or
other surgical intervention, and is intended for use by a person age 18
or older to compensate for perceived mild to moderate hearing
impairment. The device, through tools, tests, or software, allows the
user to control the hearing aid and customize it to the user's hearing
needs. The device may use wireless technology or may include tests for
self-assessment of hearing loss. The device is available over-the-
counter, without the supervision, prescription, or other order,
involvement, or intervention of a licensed person, to consumers through
in-person transactions, by mail, or online, provided that the device
satisfies the requirements in this section.
Prescription hearing aid. A prescription hearing aid is a hearing
aid that is not an OTC hearing aid as defined in this section or a
hearing aid that does not satisfy the requirements in this section.
Rebuilt hearing aid. An OTC hearing aid is ``rebuilt'' if the
manufacturer has inspected and tested the device, made any necessary
modifications to ensure it meets applicable regulatory requirements,
including the requirements in this section to be available OTC, and
adequately reprocessed the device for the next user.
Sale. Sale includes a lease, rental, or any other purchase or
exchange for value.
Tools, tests, or software. Tools, tests, or software are components
of the device that, individually or in combination, allow a lay user to
control the device and customize it sufficiently, such as the device's
output, to meet the user's hearing needs.
Used hearing aid. A hearing aid is ``used'' if a user has worn it
for any period of time. However, a hearing aid shall not be ``used''
merely because a prospective user wore it as part of a bona fide
hearing aid evaluation to determine whether to select that particular
hearing aid for that prospective user. A hearing aid evaluation is
``bona fide'' if it was conducted in the presence of the dispenser or a
hearing health professional selected by the dispenser to assist the
prospective user in making a determination.
(c) Labeling. An OTC hearing aid shall bear all of the following in
the labeling:
(1) Outside package labeling. The outside package of an OTC hearing
aid shall bear all of the following:
(i) Warnings and other important information. All of the following
shall appear on the outside package:
(A) (A) Warning against use in people younger than 18.
BILLING CODE 4164-01-P
[GRAPHIC] [TIFF OMITTED] TR17AU22.000
(B) Symptoms suggesting perceived mild to moderate hearing loss.
[GRAPHIC] [TIFF OMITTED] TR17AU22.001
[[Page 50750]]
(C) Advice of availability of professional services.
[GRAPHIC] [TIFF OMITTED] TR17AU22.002
(D) ``Red flag'' conditions.
[GRAPHIC] [TIFF OMITTED] TR17AU22.003
(E) Notice of contact information.
[GRAPHIC] [TIFF OMITTED] TR17AU22.004
(F) Notice of manufacturer's return policy.
[[Page 50751]]
[GRAPHIC] [TIFF OMITTED] TR17AU22.005
(ii) Statement of build condition. If the OTC hearing aid is used
or rebuilt, the outside package shall declare that fact. A sticker
under and visible through the outer wrapper will suffice to declare
such fact.
(iii) Statement of OTC availability. The principal display panel
shall bear the marks ``OTC'' and ``hearing aid'' with the same
prominence required under Sec. 801.61(c) of this chapter for the
device's statement of identity. The device's common name on the
principal display panel may satisfy all or part of this requirement to
the extent the common name includes the marks.
(iv) Indication of battery information. The outside package shall
indicate the type and number of batteries and whether batteries are
included in the package.
(v) Indication of control platform. The outside package shall
indicate whether a mobile device or other non-included control platform
is required. The indication must include the type of platform and how
the platform connects to the device.
(2) Labeling, inside the package. The manufacturer or distributor
of an OTC hearing aid shall include a user instructional brochure
inside the package and shall make an electronic version available for
download without site or customer registration and without requiring
purchase of any product or service. The user instructional brochure
shall include all of the following:
(i) The following warnings, which shall appear in the following
order and prior to any content except the cover page:
(A) Warning against use in people younger than 18.
[GRAPHIC] [TIFF OMITTED] TR17AU22.006
(B) ``Red flag'' conditions.
[GRAPHIC] [TIFF OMITTED] TR17AU22.007
[[Page 50752]]
(C) Warning about pain from device placement.
[GRAPHIC] [TIFF OMITTED] TR17AU22.008
(ii) Any additional warnings the manufacturer may include prior to
the cautions and notices to users in paragraph (c)(2)(iii) of this
section.
(iii) The following cautions and notices for users, which shall
appear prior to any content except the cover page and the warnings
under paragraphs (c)(2)(i) and (ii) of this section:
(A) Caution about hearing protection.
[GRAPHIC] [TIFF OMITTED] TR17AU22.009
(B) Caution about excessive sound output.
[GRAPHIC] [TIFF OMITTED] TR17AU22.010
(C) Caution about components lodging in ear.
[GRAPHIC] [TIFF OMITTED] TR17AU22.011
(D) Advice to seek professional services.
[GRAPHIC] [TIFF OMITTED] TR17AU22.012
[[Page 50753]]
(E) Note about user expectations.
[GRAPHIC] [TIFF OMITTED] TR17AU22.013
(E) Note about reporting adverse events to FDA.
[GRAPHIC] [TIFF OMITTED] TR17AU22.014
BILLING CODE 4164-01-C
(iv) An illustration(s) of the OTC hearing aid that indicates
operating controls, user adjustments, and the battery compartment.
(v) Information on the function of all controls intended for user
adjustment.
(vi) A description of any accessory that accompanies the OTC
hearing aid, including but not limited to wax guards and accessories
for use with a computer, television, or telephone.
(vii) Specific instructions for all of the following:
(A) Instructions for sizing or inserting the eartip of the OTC
hearing aid to prevent insertion past the depth limit and damage to the
tympanic membrane.
(B) The tools, tests, or software that allow the user to control
the OTC hearing aid, including self-selection and self-checking the
performance of the OTC hearing aid, and customize it to the user's
hearing needs, including information about properly fitting eartips.
(C) Use of the OTC hearing aid with any accompanying accessories.
(D) Maintenance and care of the OTC hearing aid, including how a
lay user can clean, disinfect, and replace parts or how to seek
replacements, as well as how to store the hearing aid when it will not
be used for an extended period of time.
(E) If the battery is replaceable or rechargeable, how to replace
or recharge the battery, including a generic designation of replacement
batteries.
(F) Expected battery life.
(G) Any other information necessary for adequate directions for use
as defined in Sec. 801.5 of this chapter.
(viii) Identification of any known physiological side effects
associated with the use of the OTC hearing aid that may warrant
consultation with a physician, referring to an ear-nose-throat doctor
when preferable, including if applicable, skin irritation and
accelerated accumulation of cerumen (ear wax).
(ix) The technical specifications required by paragraph (c)(4) of
this section.
(x) A description of commonly occurring, avoidable events that
could adversely affect or damage the OTC hearing aid, including but not
limited to, as applicable, ear wax buildup, drops, immersion in water,
or exposure to excessive heat.
(xi) If the hearing aid incorporates wireless technology in its
programming or use, appropriate warnings, instructions, and information
relating to electromagnetic compatibility and wireless technology and
human exposure to non-ionizing radiation.
(xii) Information on how and where to obtain repair service or
replacements, including at least one specific address where the user
can go or send the OTC hearing aid to obtain such repair service or
replacements.
(xiii) If clinical or non-clinical studies were conducted by or for
the manufacturer to support the
[[Page 50754]]
performance of the OTC hearing aid, a summary of all such studies.
(3) Labeling on the device. The labeling on an OTC hearing aid
itself shall bear all of the following clearly and permanently, except
as provided in paragraph (c)(3)(iii) of this section:
(i) The serial number.
(ii) If the battery is removable, a ``+'' symbol to indicate the
positive terminal for battery insertion unless the battery's physical
design prevents inserting the battery in the reversed position.
(iii) If the OTC hearing aid is used or rebuilt, the manufacturer
shall physically attach a removable tag to the hearing aid declaring
that fact.
(4) Technical specifications. All of the following technical
specifications shall appear in the user instructional brochure that
accompanies the device. You may additionally include it on the outside
package:
(i) The maximum output limit value (Output Sound Pressure Level 90
(OSPL90)).
(ii) The full-on gain value, which is the gain with a 50 decibel
(dB) Sound Pressure Level (SPL) pure-tone input and volume set to full
on.
(iii) The total harmonic distortion value.
(iv) The self-generated noise value.
(v) The latency value.
(vi) The upper and lower cutoff frequencies for bandwidth.
(5) Software device labeling. OTC hearing aid software that is not
distributed with the hearing aid or amplification platform shall meet
all of the following labeling requirements. With respect to the
information required under paragraphs (c)(1) through (4) of this
section, the information must be provided in the software device
labeling, as specified in paragraphs (c)(5)(i) through (v) of this
section, rather than the locations (e.g., outside package labeling)
specified in paragraphs (c)(1) through (4):
(i) Prior to first use of the software or obtaining payment
information for the software, whichever occurs first, the labeling must
clearly and prominently present all of the following to the prospective
user. For each, the labeling must remain visible until the user
dismisses it or proceeds to the next step:
(A) Compatibility and minimum operating requirements for the
software device.
(B) Disclosures of any fees or payments after first use or initial
payment, including but not limited to any fees or payments relating to
subscriptions, add-on features, or continued access to features or
services. The disclosures must name and briefly describe what each fee
or payment covers.
(C) The information required under paragraphs (c)(1)(i), (iii), and
(v) of this section.
(ii) Prior to first use of the software, the labeling must clearly
and prominently present all of the following to the prospective user:
(A) The information required under paragraph (c)(2)(i)(A) of this
section, and it must remain visible until the user acknowledges it.
(B) The information required under paragraphs (c)(2)(i)(B) and (C),
(c)(2)(ii), (iii), and (v), (c)(2)(vii)(B) and (G), and (c)(2)(viii)
and (ix) of this section, and the information must remain visible until
the user dismisses it or proceeds to the next step.
(C) All other information required under paragraph (c)(2) of this
section, to the extent applicable, and the information must remain
visible until the user dismisses it or proceeds to the next step.
(iii) The software device labeling must include the information
required under paragraphs (c)(3)(i) and (c)(4) of this section.
(iv) All of the software device labeling must be accessible for
review after acknowledgment, dismissal, or proceeding to the next step.
(v) If there are changes to any of the labeling required under
paragraph (c)(5) of this section, the labeling with the changed
information must be presented to the user until the user dismisses it.
(d) Output limits. The output limit for an OTC hearing aid shall be
the device maximum acoustic output sound pressure level (SPL) with an
acoustic coupler as described in paragraph (e)(6) of this section when
the device input is a 90 dB SPL pure-tone, and the gain/volume control
is full on. An OTC hearing aid shall not exceed the following limits at
any of the frequencies at which the device is intended to operate:
(1) General output limit. An OTC hearing aid shall not exceed an
output limit of 111 dB SPL at any frequency except as provided in
paragraph (d)(2) of this section.
(2) Output limit for a device with activated input-controlled
compression. An OTC hearing aid that has input-controlled compression
activated shall not exceed an output limit of 117 dB SPL at any
frequency.
(e) Electroacoustic performance limits. An OTC hearing aid shall
perform within all of the following electroacoustic limits. Measure
each electroacoustic performance characteristic using an acoustic
coupler as described in paragraph (e)(6) of this section, where
applicable:
(1) Output distortion control limits. Test the output distortion of
the OTC hearing aid as follows to ensure that it does not exceed the
limit specified in paragraphs (e)(1)(i) through (iii) of this section.
(i) The total harmonic distortion plus noise shall not exceed 5
percent for output levels within one of the following sets of levels,
depending on the test method:
(A) Using sine wave-based testing, measure at 70 dB SPL and 100 dB
SPL; or
(B) Using a 500-hertz (Hz) one-third-octave pulsed-noise signal,
measure at 67 dB SPL and 97 dB SPL.
(ii) You must measure the total harmonic distortion using a 500-Hz
input tone with an analyzer that has a bandwidth at least as wide as
the frequency limits of the OTC hearing aid.
(iii) You must measure the output distortion at the OTC hearing
aid's maximum volume and the input sound level to the OTC hearing aid
adjusted to produce the required outputs.
(2) Self-generated noise level limits. Self-generated noise shall
not exceed 32 dBA. You must disable any methods that artificially lower
the apparent noise floor for the measurement. Such methods would
include but are not limited to auto-muting and downward expansion.
(3) Latency. Latency shall not exceed 15 ms. You must measure the
latency with a method that is accurate and repeatable to within 1.5 ms.
(4) Frequency response bandwidth. The lower cutoff frequency shall
extend to 250 Hz or below, and the upper cutoff frequency shall extend
to 5 kHz or greater. You must measure the frequency response bandwidth
as specified in the Method for clause 4.1 in ANSI/CTA-2051:2017.
(5) Frequency response smoothness. No single peak in the one-third-
octave frequency response shall exceed 12 dB relative to the average
levels of the one-third-octave bands, two-thirds octave above and below
the peak. You must measure the frequency response smoothness using
values for a diffuse field and the corrected one-third-octave frequency
insertion response as specified in the Method for clause 4.1 in ANSI/
CTA-2051:2017.
(6) Acoustic coupler choice. Where applicable, use one of the
following acoustic couplers to measure electroacoustic performance:
(i) When compatible with the device design, a 2-cubic centimeter
(cm\3\) acoustic coupler; or
[[Page 50755]]
(ii) When a 2-cm\3\ acoustic coupler is not compatible with the
device design, an acoustic coupler that is a scientifically valid and
technically equivalent alternative. You must document the rationale for
using an alternative acoustic coupler.
(f) Design requirements. An OTC hearing aid must conform to all of
the following design requirements:
(1) Insertion depth. The design of an OTC hearing aid shall limit
the insertion of the most medial component so that, when inserted, the
component is reasonably expected to remain at least 10 millimeters (mm)
from the tympanic membrane.
(2) Use of atraumatic materials. The material for the eartip of an
OTC hearing aid shall be atraumatic.
(3) Proper physical fit. The design of an OTC hearing aid shall
enable consumers to readily achieve a safe, customized, acoustically
favorable, and comfortable physical fit in the ear canal and/or
external ear.
(4) Tools, tests, or software. The OTC hearing aid shall, through
tools, tests, or software, permit a lay user to control the device and
customize it to the user's hearing needs.
(5) User-adjustable volume control. The OTC hearing aid shall have
a user-adjustable volume control.
(6) Adequate reprocessing. If the OTC hearing aid is used or
rebuilt, it must be adequately reprocessed for the next user prior to
sale.
(g) Conditions for sale of an OTC hearing aid. The sale of an OTC
hearing aid is subject to all of the following conditions:
(1) Age minimum. Sale to or for a person younger than 18 years of
age is prohibited.
(2) Statement of OTC availability. Sale of an OTC hearing aid is
prohibited unless its labeling bears the statement of OTC availability
required under paragraph (c)(1)(iii) of this section.
(h) Effect on State law. Any State or local government requirement
for an OTC hearing aid is preempted to the following extent:
(1) Preemption. No State or local government shall establish or
continue in effect any law, regulation, order, or other requirement
specifically related to hearing products that would restrict or
interfere with the servicing, marketing, sale, dispensing, use,
customer support, or distribution of OTC hearing aids through in-person
transactions, by mail, or online, that is different from, in addition
to, or otherwise not identical to, the regulations promulgated under
section 709(b) of the FDA Reauthorization Act of 2017, including any
State or local requirement for the supervision, prescription, or other
order, involvement, or intervention of a licensed person for consumers
to access OTC hearing aids.
(2) Professional requirements--(i) General rule. The servicing,
marketing, sale, dispensing, customer support, or distribution of OTC
hearing aids, or an equivalent activity, whether through in-person
transactions, by mail, or online, shall not cause, require, or
otherwise obligate a person providing such services to obtain
specialized licensing, certification, or any other State or local
sanction unless such requirement is generally applicable to the sale of
any product or to all places of business regardless of whether they
sell OTC hearing aids. However, although a State or local government
may not require the order, involvement, or intervention of a licensed
person for consumers to access OTC hearing aids, a licensed person may
service, market, sell, dispense, provide customer support for, or
distribute OTC hearing aids.
(ii) Sale of OTC hearing aids is not an exemption. The servicing,
marketing, sale, dispensing, customer support, or distribution of OTC
hearing aids does not exempt a person from any State or local
government's professional or establishment requirements that are
consistent with this section.
(iii) Representations may create professional obligations. A person
shall not incur specialized obligations by representing as a servicer,
marketer, seller, dispenser, customer support representative, or
distributor (or an equivalent description) of OTC hearing aids.
However, a person representing as any other defined professional or
establishment, or as a State licensed dispenser, is subject to
applicable State and local requirements even if the person undertakes
commercial or professional activities only in relation to OTC hearing
aids.
(3) Private remedies. This section does not modify or otherwise
affect the ability of any person to exercise a private right of action
under any State or Federal product liability, tort, warranty, contract,
or consumer protection law.
(i) Incorporation by reference. ANSI/CTA-2051, ``Personal Sound
Amplification Performance Criteria,'' dated January 2017 (ANSI/CTA-
2051:2017), is incorporated by reference into this section with the
approval of the Director of the Office of the Federal Register under 5
U.S.C. 552(a) and 1 CFR part 51. This material is available for
inspection at the Food and Drug Administration and at the National
Archives and Records Administration (NARA). Contact the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
240-402-7500. For information on the availability of this material at
NARA, email: [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html. The material may be obtained
from Consumer Technology Association (CTA), Technology & Standards
Department, 1919 S Eads Street, Arlington, VA 22202; phone: 703-907-
7600; fax: (703) 907-7693; email: [email protected], website:
www.cta.tech.
PART 801--LABELING
0
3. The authority citation for part 801 is revised to read as follows:
Authority: 21 U.S.C. 321, 331-334, 351, 352, 360d, 360i, 360j,
371, 374.
Sec. 801.420 [Removed]
0
4. Remove Sec. 801.420.
Sec. 801.421 [Removed]
0
5. Remove Sec. 801.421.
0
6. Add Sec. 801.422 to subpart H to read as follows:
Sec. 801.422 Prescription hearing aid labeling.
(a) Scope. This section specifies the labeling requirements for
prescription hearing aids. Any hearing aid that does not satisfy the
requirements of Sec. 800.30 of this chapter shall be a prescription
device. Unless otherwise specified, the requirements in this section
are in addition to other applicable requirements, including but not
limited to special controls found in the applicable classification
regulation in part 874 of this chapter. This section does not apply to
group auditory trainers.
(b) Definitions for the purposes of this section. This section uses
the following definitions:
Dispenser. A dispenser is any person, as defined in section 201(e)
of the Federal Food, Drug, and Cosmetic Act, engaged in the sale of
hearing aids to any member of the consuming public or any employee,
agent, salesperson, and/or representative of such a person.
Hearing aid. A hearing aid is any wearable device designed for,
offered for the purpose of, or represented as aiding persons with or
compensating for, impaired hearing.
Prescription hearing aid. A prescription hearing aid is a hearing
aid that is not an over-the-counter (OTC) hearing aid as defined in
Sec. 800.30 of this chapter or a hearing aid that does not satisfy the
requirements in Sec. 800.30 of this chapter.
[[Page 50756]]
Rebuilt hearing aid. A prescription hearing aid is ``rebuilt'' if
the manufacturer has inspected and tested the device, made any
necessary modifications to ensure it meets applicable regulatory
requirements, including the requirements in this section, and
adequately reprocessed the device for the next user.
Sale. Sale includes a lease, rental, or any other purchase or
exchange for value.
Used hearing aid. A hearing aid is ``used'' if a user has worn it
for any period of time. However, a hearing aid shall not be ``used''
merely because a prospective user wore it as part of a bona fide
hearing aid evaluation to determine whether to select that particular
hearing aid for that prospective user. A hearing aid evaluation is
``bona fide'' if it was conducted in the presence of the dispenser or a
hearing health professional selected by the dispenser to assist the
prospective user in making a determination.
(c) Labeling. A prescription hearing aid shall bear all of the
following labeling:
(1) Outside package labeling. The outside package of a prescription
hearing aid shall bear all of the following:
(i) Warnings and other important information. All of the following
shall appear on the outside package:
(A) Warning against use in people younger than 18 without prior
medical evaluation.
BILLING CODE 4164-01-P
[GRAPHIC] [TIFF OMITTED] TR17AU22.015
(B) ``Red flag'' conditions.
[GRAPHIC] [TIFF OMITTED] TR17AU22.016
(C) Note about device trial options.
[[Page 50757]]
[GRAPHIC] [TIFF OMITTED] TR17AU22.017
(ii) Statement of build condition. If the prescription hearing aid
is used or rebuilt, the outside package shall declare that fact. A
sticker under and visible through the outer wrapper will suffice to
declare such fact.
(iii) Indication of battery information. The outside package shall
indicate the type and number of batteries and whether batteries are
included in the package.
(iv) Indication of control platform. That outside package shall
indicate whether a mobile device or other non-included control platform
is required. The indication must include the type of platform and how
the platform connects to the device.
(2) Labeling, inside the package. The manufacturer or distributor
of a prescription hearing aid shall include a user instructional
brochure inside the package and shall make an electronic version
available for download without site or customer registration and
without requiring purchase of any product or service. The user
instructional brochure shall include all of the following:
(i) The following warnings, which shall appear in the following
order and prior to any content except the cover page:
(A) Warning against use in people younger than 18 without prior
medical evaluation.
[GRAPHIC] [TIFF OMITTED] TR17AU22.018
(B) ``Red flag'' conditions, addressed to dispensers.
[[Page 50758]]
[GRAPHIC] [TIFF OMITTED] TR17AU22.019
(C) Warning to dispensers about very high-output devices.
[GRAPHIC] [TIFF OMITTED] TR17AU22.020
(D) Additional warnings. Any additional warnings the manufacturer
may include prior to the cautions and notices to users in paragraph
(c)(2)(ii) of this section.
(ii) The following cautions and notices for users, which shall
appear prior to any content, except the cover page and the warnings
under paragraph (c)(2)(i) of this section:
(A) Caution about hearing protection.
[GRAPHIC] [TIFF OMITTED] TR17AU22.021
(B) Caution about excessive sound output.
[[Page 50759]]
[GRAPHIC] [TIFF OMITTED] TR17AU22.022
(C) Caution about components lodging in ear.
[GRAPHIC] [TIFF OMITTED] TR17AU22.023
(D) Note about user expectations.
[GRAPHIC] [TIFF OMITTED] TR17AU22.024
(E) Note about reporting adverse events to FDA.
[GRAPHIC] [TIFF OMITTED] TR17AU22.025
(F) Note about hearing loss in people younger than 18 and fitting
devices.
[[Page 50760]]
[GRAPHIC] [TIFF OMITTED] TR17AU22.026
BILLING CODE 4164-01-C
(iii) An illustration(s) of the prescription hearing aid that
indicates operating controls, user adjustments, and the battery
compartment.
(iv) Information on the function of all controls intended for user
adjustment.
(v) A description of any accessory that accompanies the
prescription hearing aid, including but not limited to wax guards, and
accessories for use with a computer, television, or telephone.
(vi) Specific instructions for all of the following:
(A) Use of the prescription hearing aid with any accompanying
accessories.
(B) Maintenance and care of the prescription hearing aid, including
how a user can clean, disinfect, and replace parts or how to seek
replacements, as well as how to store the hearing aid when it will not
be used for an extended period of time.
(C) If the battery is replaceable or rechargeable, how to replace
or recharge the battery, including a generic designation of replacement
batteries.
(D) Expected battery life.
(vii) Identification of any known physiological side effects
associated with the use of the prescription hearing aid that may
warrant consultation with a physician, referring to an ear-nose-throat
doctor when preferable, including if applicable, skin irritation and
accelerated accumulation of cerumen (ear wax).
(viii) The technical specifications required by paragraph (c)(4) of
this section unless such specifications appear in separate labeling
accompanying the prescription hearing aid.
(ix) A description of commonly occurring, avoidable events that
could adversely affect or damage the prescription hearing aid,
including but not limited to, as applicable, ear wax buildup, drops,
immersion in water, or exposure to excessive heat.
(x) If the hearing aid incorporates wireless technology in its
programming or use, appropriate warnings, instructions, and information
relating to electromagnetic compatibility and wireless technology and
human exposure to non-ionizing radiation.
(xi) Information on how and where to obtain repair service or
replacements, including at least one specific address where the user
can go or send the prescription hearing aid to obtain such repair
service or replacements.
(xii) If clinical or non-clinical studies were conducted by or for
the manufacturer to support the performance of the prescription hearing
aid, a summary of all such studies.
(3) Labeling on the device. The labeling on a prescription hearing
aid itself shall bear all of the following clearly and permanently,
except as
[[Page 50761]]
provided in paragraph (c)(3)(iii) of this section:
(i) The serial number.
(ii) If the battery is removable, a ``+'' symbol to indicate the
positive terminal for battery insertion unless the battery's physical
design prevents inserting the battery in the reversed position.
(iii) If the prescription hearing aid is used or rebuilt, the
manufacturer shall physically attach a removable tag to the hearing aid
declaring that fact.
(4) Technical specifications. You must determine the technical
specification values for the prescription hearing aid labeling in
accordance with the test procedures of ANSI/ASA S3.22-2014 (R2020),
except as provided in paragraph (c)(4)(ix) of this section for latency.
Technical specifications and their associated values that are useful in
selecting, fitting, and checking the performance of the prescription
hearing aid shall appear in the user instructional brochure or in
separate labeling that accompanies the device, including all of the
following:
(i) Saturation output curve (Saturation Sound Pressure Level (SSPL)
90 curve).
(ii) Frequency response curve.
(iii) Average saturation output (High Frequency (HF)-Average SSPL
90).
(iv) Average full-on gain (HF-Average full-on gain).
(v) Reference test gain.
(vi) Frequency range.
(vii) Total harmonic distortion.
(viii) Equivalent input noise.
(ix) Latency, measured using a method that is accurate and
repeatable to within 1.5 ms.
(x) Battery current drain.
(xi) Induction coil sensitivity (telephone coil aids only).
(xii) Input-output curve (only for hearing aids with automatic gain
control).
(xiii) Attack and release times (only for hearing aids with
automatic gain control).
(5) Software device labeling. Prescription hearing aid software
that is not distributed with the hearing aid or amplification platform
shall meet all of the following labeling requirements. With respect to
the information required under paragraphs (c)(1) through (4) of this
section, the information must be provided in the software device
labeling, as specified in paragraphs (c)(5)(i) through (v) of this
section, rather than the locations (e.g., outside package labeling)
specified in paragraphs (c)(1) through (4).
(i) Prior to first use of the software or obtaining payment
information for the software, whichever occurs first, the labeling must
clearly and prominently present all of the following to the prospective
user. For each, the labeling must remain visible until the user
dismisses it or proceeds to the next step:
(A) Compatibility and minimum operating requirements for the
software device.
(B) Disclosures of any fees or payments after first use or initial
payment, including but not limited to any fees or payments relating to
subscriptions, add-on features, or continued access to features or
services. The disclosures must name and briefly describe what each fee
or payment covers.
(C) The information required under paragraphs (c)(1)(i) and (iv) of
this section.
(ii) Prior to first use of the software, the labeling must clearly
and prominently present all of the following to the prospective user:
(A) The information required under paragraph (c)(2)(i)(A) of this
section, and it must remain visible until the user acknowledges it.
(B) The information required under paragraphs (c)(2)(i)(B) through
(D) and (c)(2)(ii), (iv), (vii), and (viii) of this section, and the
information must remain visible until the user dismisses it or proceeds
to the next step.
(C) All other information required under paragraph (c)(2) of this
section, to the extent applicable, and the information must remain
visible until the user dismisses it or proceeds to the next step.
(iii) The software device labeling must include the information
required under paragraphs (c)(3)(i) and (c)(4) of this section.
(iv) All of the software device labeling must be accessible for
review after acknowledgment, dismissal, or proceeding to the next step.
(v) If there are changes to any of the labeling required under
paragraph (c)(5) of this section, the labeling with the changed
information must be presented to the user until the user dismisses it.
(6) Misbranding. A prescription hearing aid that is not labeled as
required under this section and Sec. 801.109 is misbranded under
sections 201(n), 502(a), and/or 502(f) of the Federal Food, Drug, and
Cosmetic Act.
(d) Incorporation by reference. ANSI/ASA S3.22-2014 (R2020),
``AMERICAN NATIONAL STANDARD Specification of Hearing Aid
Characteristics,'' dated June 5, 2020, is incorporated by reference
into this section with the approval of the Director of the Office of
the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. This
material is available for inspection at the Food and Drug
Administration and at the National Archives and Records Administration
(NARA). Contact the Dockets Management Staff, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240-402-7500. For information on the
availability of this material at NARA, email: [email protected],
or go to: www.archives.gov/federal-register/cfr/ibr-locations.html. The
material may be obtained from the Acoustical Society of America (ASA),
1305 Walt Whitman Road, Suite 300, Melville, NY 11747; phone: (631)
390-0215; fax: (631) 923-2875; email: [email protected].
PART 808--EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL
MEDICAL DEVICE REQUIREMENTS
0
7. The authority citation for part 808 is revised to read as follows:
Authority: 21 U.S.C. 360j, 360k, 371.
Section 808.1 also issued under Sec. 709, Public Law 115-52, 131
Stat. 1065-67.
0
8. In part 808, remove the words ``the act'' and add in their place
``the Federal Food, Drug, and Cosmetic Act''.
0
9. In Sec. 808.1, add headings to paragraphs (a) through (f) and add
paragraph (g) to read as follows:
Sec. 808.1 Scope.
(a) Introduction. * * *
(b) General rule for State and local requirements respecting
devices. * * *
(c) Exempting from preemption certain State or local requirements
respecting devices. * * *
(d) Meaning of ``requirements applicable to a device.'' * * *
(e) Determination of equivalence or difference of requirements
applicable to a device. * * *
(f) Applicability of Federal requirements respecting devices. * * *
(g) Exemptions not applicable to certain State or local government
requirements specifically related to hearing products. An exemption
under this part shall not apply to any State or local government law,
regulation, order, or other requirement specifically related to hearing
products, including any requirement for the supervision, prescription,
or other order, involvement, or intervention of a licensed person for
consumers to access over-the-counter hearing aids, that:
(1) Would restrict or interfere with the servicing, marketing,
sale, dispensing, use, customer support, or distribution of over-the-
counter hearing aids, as defined under section 520(q) of the Federal
Food, Drug, and Cosmetic Act, through in-person transactions, by mail,
or online; and
(2) Is different from, in addition to, or otherwise not identical
to, the
[[Page 50762]]
regulations issued under section 709(b) of the FDA Reauthorization Act
of 2017.
0
10. Revise Sec. 808.3 to read as follows:
Sec. 808.3 Definitions.
Compelling local conditions includes any factors, considerations,
or circumstances prevailing in, or characteristic of, the geographic
area or population of the State or political subdivision that justify
exemption from preemption.
More stringent refers to a requirement of greater restrictiveness
or one that is expected to afford to those who may be exposed to a risk
of injury from a device a higher degree of protection than is afforded
by a requirement applicable to the device under the Federal Food, Drug,
and Cosmetic Act.
Political subdivision or locality means any lawfully established
local governmental unit within a State which unit has the authority to
establish or continue in effect any requirement having the force and
effect of law with respect to a device intended for human use.
State means any State or Territory of the United States, including
but not limited to, the District of Columbia and the Commonwealth of
Puerto Rico.
Substantially identical to refers to the fact that a State or local
requirement does not significantly differ in effect from a Federal
requirement.
Sec. 808.53 [Removed and Reserved]
0
11. Remove and reserve Sec. 808.53.
0
12. Revise Sec. 808.55 to read as follows:
Sec. 808.55 California.
The following California medical device requirements are preempted
under section 521(a) of the Federal Food, Drug, and Cosmetic Act, and
FDA has denied them exemption from preemption:
(a) Medical devices; general provisions. Sherman Food, Drug, and
Cosmetic Law, Division 21 of the California Health and Safety Code,
sections 26207, 26607, 26614, 26615, 26618, 26631, 26640, and 26441, to
the extent that they apply to devices; and
(b) Ophthalmic devices; quality standards. California Business and
Professions Code, section 2541.3 to the extent that it requires
adoption of the American National Standards Institute standards Z-80.1
and Z-80.2.
Sec. Sec. 808.57 through 808.101 [Removed and Reserved]
0
13. Remove and reserve Sec. Sec. 808.57 through 808.101.
PART 874--EAR, NOSE, AND THROAT DEVICES
0
14. The authority citation for part 874 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
15. Revise Sec. 874.3300 to read as follows:
Sec. 874.3300 Air-conduction hearing aid.
(a) Identification. An air-conduction hearing aid is a wearable
sound-amplifying device intended to compensate for impaired hearing
that conducts sound to the ear through the air. An air-conduction
hearing aid is subject to the requirements in Sec. 800.30 or Sec.
801.422 of this chapter, as applicable. The air-conduction hearing aid
generic type excludes the group hearing aid or group auditory trainer,
master hearing aid, and the tinnitus masker, regulated under Sec. Sec.
874.3320, 874.3330, and 874.3400, respectively.
(b) Classification. Class I (general controls). This device is
exempt from premarket notification procedures in subpart E of part 807
of this chapter, subject to the limitations in Sec. 874.9.
0
16. Add Sec. 874.3302 to read as follows:
Sec. 874.3302 Bone-conduction hearing aid.
(a) Identification. A bone-conduction hearing aid is a wearable
sound-amplifying device intended to compensate for impaired hearing and
that conducts sound to the inner ear through the skull. The non-
implantable components of a bone-conduction hearing aid, such as the
external sound processor, are subject to the requirements in Sec.
801.422 of this chapter.
(b) Classification. Class II.
0
17. In Sec. 874.3305, add a sentence at the end of paragraph (a) and
revise paragraph (b) to read as follows:
Sec. 874.3305 Wireless air-conduction hearing aid.
(a) * * * A wireless air-conduction hearing aid is subject to the
requirements in Sec. 800.30 or Sec. 801.422 of this chapter, as
applicable.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Performance data must demonstrate the electromagnetic
compatibility (EMC), electrical safety, and thermal safety of the
device;
(2) Performance testing must validate safety of exposure to non-
ionizing radiation; and
(3) Performance data must validate wireless technology functions.
* * * * *
0
18. In Sec. 874.3315, revise paragraph (a) to read as follows:
Sec. 874.3315 Tympanic membrane contact hearing aid.
(a) Identification. A tympanic membrane contact hearing aid is a
prescription wearable device that compensates for impaired hearing.
Amplified sound is transmitted by vibrating the tympanic membrane
through a transducer that is in direct contact with the tympanic
membrane. A tympanic membrane contact hearing aid is subject to the
requirements in Sec. 801.422 of this chapter.
* * * * *
0
19. In Sec. 874.3325:
0
a. Add a sentence at the end of paragraph (a);
0
b. Revise paragraph (b)(5); and
0
c. Remove paragraph (b)(7).
The addition and revision read as follows:
Sec. 874.3325 Self-fitting air-conduction hearing aid.
(a) * * * A self-fitting air-conduction hearing aid is subject to
the requirements in Sec. 800.30 or Sec. 801.422 of this chapter, as
applicable.
(b) * * *
(5) If the device incorporates wireless technology:
(i) Performance testing must validate safety of exposure to non-
ionizing radiation; and
(ii) Performance data must validate wireless technology functions.
* * * * *
0
20. In Sec. 874.3950, add a sentence at the end of paragraph (a) to
read as follows:
Sec. 874.3950 Transcutaneous air conduction hearing aid system.
(a) * * * A transcutaneous air conduction hearing aid system is
subject to the requirements in Sec. 801.422 of this chapter.
* * * * *
Dated: August 5, 2022.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2022-17230 Filed 8-16-22; 8:45 am]
BILLING CODE 4164-01-P