Medical Devices; Ear, Nose, and Throat Devices; Classification of the Tympanic Membrane Contact Hearing Aid, 3325-3327 [2016-01090]

Download as PDF Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 874 [Docket No. FDA–2015–N–4328] Medical Devices; Ear, Nose, and Throat Devices; Classification of the Tympanic Membrane Contact Hearing Aid AGENCY: Food and Drug Administration, HHS. ACTION: Final order. The Food and Drug Administration (FDA) is classifying the tympanic membrane contact hearing aid into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the tympanic membrane contact hearing aid’s classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. DATES: This order is effective January 21, 2016. The classification was applicable on September 29, 2015. FOR FURTHER INFORMATION CONTACT: Cherish Giusto, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2432, Silver Spring, MD 20993–0002, 301–796–9679, cherish.giusto@fda.hhs.gov. SUPPLEMENTARY INFORMATION: SUMMARY: I. Background In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i), to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations. Section 513(f)(2) of the FD&C Act, as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112–144), provides two procedures by which a person may request FDA to classify a device under the criteria set forth in section 513(a)(1). Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1) of the FD&C Act, the person requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a premarket notification under section 510(k) of the FD&C Act and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device or if FDA determines that the device submitted is not of ‘‘lowmoderate risk’’ or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed. In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA will classify the device by written order within 120 days. This classification will be the initial classification of the device. On January 5, 2015, EarLens Corporation submitted a request for classification of the EarLensTM Contact Hearing Device under section 513(f)(2) of the FD&C Act. The manufacturer recommended that the device be classified into class II (Ref. 1). In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. FDA classifies devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the request, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on September 29, 2015, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 874.3315. Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for a tympanic membrane contact hearing aid will need to comply with the special controls named in this final administrative order. The device is assigned the generic name tympanic membrane contact hearing aid, and it is identified as a prescription 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. FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks: TABLE 1—TYMPANIC MEMBRANE CONTACT HEARING AID RISKS AND MITIGATION MEASURES jstallworth on DSK7TPTVN1PROD with RULES Identified risks Mitigation methods Adverse Tissue Reactions ....................................................................................................................... Electromagnetic Incompatibility ................................................................................................................ MRI Incompatibility ................................................................................................................................... Overheating of Ear Canal or Skin ............................................................................................................ VerDate Sep<11>2014 15:08 Jan 20, 2016 Jkt 238001 PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 3325 Biocompatibility. Labeling. Non-Clinical Performance Testing. Labeling. Labeling. Non-Clinical Performance Testing. Clinical Performance Testing. E:\FR\FM\21JAR1.SGM 21JAR1 3326 Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Rules and Regulations TABLE 1—TYMPANIC MEMBRANE CONTACT HEARING AID RISKS AND MITIGATION MEASURES—Continued Identified risks Mitigation methods Damage to Eyes from Direct Laser Exposure 1 ....................................................................................... Trauma/Damage to the Ear Canal, Tympanic Membrane, or Middle Ear System ................................. Residual Hearing Loss ............................................................................................................................. Ear Infections ........................................................................................................................................... Vertigo or Tinnitus .................................................................................................................................... Dampening of Residual Hearing When the Device is Turned Off ........................................................... Labeling. Labeling. Non-Clinical Performance Testing. Clinical Performance Testing. Training. Labeling. Non-Clinical Performance Testing. Clinical Performance Testing. Labeling. Clinical Performance Testing. Labeling. Clinical Performance Testing. Labeling. Clinical Performance Testing. Labeling. 1 A tympanic membrane contact hearing aid may contain a Class 1 laser product in its removable external component, which users will remove from their ear when the device is not in use (for example, to sleep or bathe). When being handled off of the ear, it is possible that the user could look directly at the laser. Thus, there is a risk of ‘‘damage to eyes from direct laser exposure.’’ As mitigation, the user should be warned in labeling not to look directly into the laser or aim it at their eyes. FDA believes that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of the safety and effectiveness. Tympanic membrane contact hearing aids are prescription devices restricted to patient use only upon the authorization of a practitioner licensed by law to administer or use the device; see 21 CFR 801.109 (Prescription devices). Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k), if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, this device type is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the tympanic membrane contact hearing aid they intend to market. jstallworth on DSK7TPTVN1PROD with RULES II. Environmental Impact, No Significant Impact We have determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. VerDate Sep<11>2014 15:08 Jan 20, 2016 Jkt 238001 III. Paperwork Reduction Act of 1995 This final administrative order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910–0120, and the collections of information in 21 CFR part 801, regarding labeling have been approved under OMB control number 0910–0485. IV. Reference The following reference is on display in the Division of Dockets Management (see ADDRESSES) and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at http://www.regulations.gov. FDA has verified the Web site address, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. 1. DEN150002: De novo Request per 513(f)(2) from EarLens Corporation, dated January 5, 2015. List of Subjects in 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 part 874 is amended as follows: PO 00000 Frm 00038 Fmt 4700 Sfmt 4700 PART 874—EAR, NOSE, AND THROAT DEVICES 1. The authority citation for 21 CFR part 874 continues to read as follows: ■ Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. 2. Add § 874.3315 to subpart D to read as follows: ■ § 874.3315 Tympanic membrane contact hearing aid. (a) Identification. A tympanic membrane contact hearing aid is a prescription 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. (b) Classification. Class II (special controls). The special controls for this device are: (1) The patient contacting components must be demonstrated to be biocompatible. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, and must include: (i) Mechanical integrity testing; (ii) Electrical and thermal safety testing; (iii) Software verification, validation, and hazard analysis; (iv) Reliability testing consistent with expected device life; (v) Electromagnetic compatibility testing; and (vi) Validation testing of device output and mechanical force applied to the tympanic membrane in a clinically appropriate model. (3) Clinical performance testing must characterize any adverse events observed during clinical use, and E:\FR\FM\21JAR1.SGM 21JAR1 Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Rules and Regulations demonstrate that the device performs as intended under anticipated conditions of use. (4) Professional training must include the ear impression procedure, correct placement, fitting, monitoring, care, and maintenance of the device. (5) Labeling must include the following: (i) A detailed summary of the adverse events and effectiveness outcomes from the clinical performance testing; (ii) Detailed instructions on how to fit the device to the patient; (iii) Instructions for periodic cleaning of any reusable components; (iv) Information related to electromagnetic compatibility; and (v) Patient labeling that includes: (A) A patient card that identifies if a patient has been fitted with any nonself- removable components of the device and provides relevant information in cases of emergency; (B) Information on how to correctly use and maintain the device; (C) The potential risks and benefits associated with the use of the device; and (D) Alternative treatments. Dated: January 13, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–01090 Filed 1–20–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF THE TREASURY Alcohol and Tobacco Tax and Trade Bureau 27 CFR Part 9 [Docket No. TTB–2015–0004; T.D. TTB–132; Ref: Notice No. 148] RIN 1513–AC11 Establishment of the Los Olivos District Viticultural Area Alcohol and Tobacco Tax and Trade Bureau, Treasury. ACTION: Final rule; Treasury decision. AGENCY: The Alcohol and Tobacco Tax and Trade Bureau (TTB) establishes the approximately 22,820-acre ‘‘Los Olivos District’’ viticultural area in Santa Barbara County, California. The viticultural area is located within the Santa Ynez Valley viticultural area and the larger, multicounty Central Coast viticultural area. TTB designates viticultural areas to allow vintners to better describe the origin of their wines and to allow consumers to better identify wines they may purchase. DATES: This final rule is effective February 22, 2016. jstallworth on DSK7TPTVN1PROD with RULES SUMMARY: VerDate Sep<11>2014 15:08 Jan 20, 2016 Jkt 238001 FOR FURTHER INFORMATION CONTACT: Karen A. Thornton, Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade Bureau, 1310 G Street NW., Box 12, Washington, DC 20005; phone 202–453–1039, ext. 175. SUPPLEMENTARY INFORMATION: Background on Viticultural Areas TTB Authority Section 105(e) of the Federal Alcohol Administration Act (FAA Act), 27 U.S.C. 205(e), authorizes the Secretary of the Treasury to prescribe regulations for the labeling of wine, distilled spirits, and malt beverages. The FAA Act provides that these regulations should, among other things, prohibit consumer deception and the use of misleading statements on labels and ensure that labels provide the consumer with adequate information as to the identity and quality of the product. The Alcohol and Tobacco Tax and Trade Bureau (TTB) administers the FAA Act pursuant to section 1111(d) of the Homeland Security Act of 2002, codified at 6 U.S.C. 531(d). The Secretary has delegated various authorities through Treasury Department Order 120–01, dated December 10, 2013 (superseding Treasury Department Order 120–01, dated January 24, 2003), to the TTB Administrator to perform the functions and duties in the administration and enforcement of these provisions. Part 4 of the TTB regulations (27 CFR part 4) authorizes TTB to establish definitive viticultural areas and regulate the use of their names as appellations of origin on wine labels and in wine advertisements. Part 9 of the TTB regulations (27 CFR part 9) sets forth standards for the preparation and submission of petitions for the establishment or modification of American viticultural areas (AVAs) and lists the approved AVAs. Definition Section 4.25(e)(1)(i) of the TTB regulations (27 CFR 4.25(e)(1)(i)) defines a viticultural area for American wine as a delimited grape-growing region having distinguishing features, as described in part 9 of the regulations, and a name and a delineated boundary, as established in part 9 of the regulations. These designations allow vintners and consumers to attribute a given quality, reputation, or other characteristic of a wine made from grapes grown in an area to the wine’s geographic origin. The establishment of AVAs allows vintners to describe more accurately the origin of their wines to consumers and helps consumers to identify wines they may PO 00000 Frm 00039 Fmt 4700 Sfmt 4700 3327 purchase. Establishment of an AVA is neither an approval nor an endorsement by TTB of the wine produced in that area. Requirements Section 4.25(e)(2) of the TTB regulations (27 CFR 4.25(e)(2)) outlines the procedure for proposing an AVA and provides that any interested party may petition TTB to establish a grapegrowing region as an AVA. Section 9.12 of the TTB regulations (27 CFR 9.12) prescribes standards for petitions for the establishment or modification of AVAs. Petitions to establish an AVA must include the following: • Evidence that the area within the proposed AVA boundary is nationally or locally known by the AVA name specified in the petition; • An explanation of the basis for defining the boundary of the proposed AVA; • A narrative description of the features of the proposed AVA affecting viticulture, such as climate, geology, soils, physical features, and elevation, that make the proposed AVA distinctive and distinguish it from adjacent areas outside the proposed AVA boundary; • The appropriate United States Geological Survey (USGS) map(s) showing the location of the proposed AVA, with the boundary of the proposed AVA clearly drawn thereon; and • A detailed narrative description of the proposed AVA boundary based on USGS map markings. Los Olivos District Petition TTB received a petition from C. Frederic Brander, owner and winemaker of the Brander Vineyard, proposing the establishment of the ‘‘Los Olivos District’’ AVA in Santa Barbara County, California. There are 12 bonded wineries and approximately 47 commercially producing vineyards covering a total of 1,120 acres within the proposed AVA. The proposed Los Olivos District AVA shares its western boundary with the eastern boundary of the Ballard Canyon AVA (27 CFR 9.230) and its eastern boundary with the western boundary of the Happy Canyon of Santa Barbara AVA (27 CR 9.217), but it does not overlap either of these AVAs. It is located within the Santa Ynez Valley viticultural area and the larger, multicounty Central Coast viticultural area. According to the petition, the distinguishing features of the proposed Los Olivos District AVA include its topography, soils, and climate. The proposed AVA is located on a broad alluvial terrace plain of the Santa Ynez E:\FR\FM\21JAR1.SGM 21JAR1

Agencies

[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)]
[Rules and Regulations]
[Pages 3325-3327]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01090]



[[Page 3325]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 874

[Docket No. FDA-2015-N-4328]


Medical Devices; Ear, Nose, and Throat Devices; Classification of 
the Tympanic Membrane Contact Hearing Aid

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is classifying the 
tympanic membrane contact hearing aid into class II (special controls). 
The special controls that will apply to the device are identified in 
this order and will be part of the codified language for the tympanic 
membrane contact hearing aid's classification. The Agency is 
classifying the device into class II (special controls) in order to 
provide a reasonable assurance of safety and effectiveness of the 
device.

DATES: This order is effective January 21, 2016. The classification was 
applicable on September 29, 2015.

FOR FURTHER INFORMATION CONTACT: Cherish Giusto, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2432, Silver Spring, MD 20993-0002, 301-796-9679, 
cherish.giusto@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were 
not in commercial distribution before May 28, 1976 (the date of 
enactment of the Medical Device Amendments of 1976), generally referred 
to as postamendments devices, are classified automatically by statute 
into class III without any FDA rulemaking process. These devices remain 
in class III and require premarket approval unless and until the device 
is classified or reclassified into class I or II, or FDA issues an 
order finding the device to be substantially equivalent, in accordance 
with section 513(i), to a predicate device that does not require 
premarket approval. The Agency determines whether new devices are 
substantially equivalent to predicate devices by means of premarket 
notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 
360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the 
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144), provides two procedures by which a person may request FDA to 
classify a device under the criteria set forth in section 513(a)(1). 
Under the first procedure, the person submits a premarket notification 
under section 510(k) of the FD&C Act for a device that has not 
previously been classified and, within 30 days of receiving an order 
classifying the device into class III under section 513(f)(1) of the 
FD&C Act, the person requests a classification under section 513(f)(2). 
Under the second procedure, rather than first submitting a premarket 
notification under section 510(k) of the FD&C Act and then a request 
for classification under the first procedure, the person determines 
that there is no legally marketed device upon which to base a 
determination of substantial equivalence and requests a classification 
under section 513(f)(2) of the FD&C Act. If the person submits a 
request to classify the device under this second procedure, FDA may 
decline to undertake the classification request if FDA identifies a 
legally marketed device that could provide a reasonable basis for 
review of substantial equivalence with the device or if FDA determines 
that the device submitted is not of ``low-moderate risk'' or that 
general controls would be inadequate to control the risks and special 
controls to mitigate the risks cannot be developed.
    In response to a request to classify a device under either 
procedure provided by section 513(f)(2) of the FD&C Act, FDA will 
classify the device by written order within 120 days. This 
classification will be the initial classification of the device.
    On January 5, 2015, EarLens Corporation submitted a request for 
classification of the EarLensTM Contact Hearing Device under 
section 513(f)(2) of the FD&C Act. The manufacturer recommended that 
the device be classified into class II (Ref. 1).
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed 
the request in order to classify the device under the criteria for 
classification set forth in section 513(a)(1) of the FD&C Act. FDA 
classifies devices into class II if general controls by themselves are 
insufficient to provide reasonable assurance of safety and 
effectiveness, but there is sufficient information to establish special 
controls to provide reasonable assurance of the safety and 
effectiveness of the device for its intended use. After review of the 
information submitted in the request, FDA determined that the device 
can be classified into class II with the establishment of special 
controls. FDA believes these special controls, in addition to general 
controls, will provide reasonable assurance of the safety and 
effectiveness of the device.
    Therefore, on September 29, 2015, FDA issued an order to the 
requestor classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 874.3315.
    Following the effective date of this final classification order, 
any firm submitting a premarket notification (510(k)) for a tympanic 
membrane contact hearing aid will need to comply with the special 
controls named in this final administrative order.
    The device is assigned the generic name tympanic membrane contact 
hearing aid, and it is identified as a prescription 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.
    FDA has identified the following risks to health associated 
specifically with this type of device and the measures required to 
mitigate these risks:

                  Table 1--Tympanic Membrane Contact Hearing Aid Risks and Mitigation Measures
----------------------------------------------------------------------------------------------------------------
              Identified risks                                        Mitigation methods
----------------------------------------------------------------------------------------------------------------
Adverse Tissue Reactions....................  Biocompatibility.
                                              Labeling.
Electromagnetic Incompatibility.............  Non-Clinical Performance Testing.
                                              Labeling.
MRI Incompatibility.........................  Labeling.
Overheating of Ear Canal or Skin............  Non-Clinical Performance Testing.
                                              Clinical Performance Testing.

[[Page 3326]]

 
                                              Labeling.
Damage to Eyes from Direct Laser Exposure     Labeling.
 \1\.
Trauma/Damage to the Ear Canal, Tympanic      Non-Clinical Performance Testing.
 Membrane, or Middle Ear System.
                                              Clinical Performance Testing.
                                              Training.
                                              Labeling.
Residual Hearing Loss.......................  Non-Clinical Performance Testing.
                                              Clinical Performance Testing.
                                              Labeling.
Ear Infections..............................  Clinical Performance Testing.
                                              Labeling.
Vertigo or Tinnitus.........................  Clinical Performance Testing.
                                              Labeling.
Dampening of Residual Hearing When the        Clinical Performance Testing.
 Device is Turned Off.
                                              Labeling.
----------------------------------------------------------------------------------------------------------------
\1\ A tympanic membrane contact hearing aid may contain a Class 1 laser product in its removable external
  component, which users will remove from their ear when the device is not in use (for example, to sleep or
  bathe). When being handled off of the ear, it is possible that the user could look directly at the laser.
  Thus, there is a risk of ``damage to eyes from direct laser exposure.'' As mitigation, the user should be
  warned in labeling not to look directly into the laser or aim it at their eyes.

    FDA believes that special controls, in combination with the general 
controls, address these risks to health and provide reasonable 
assurance of the safety and effectiveness.
    Tympanic membrane contact hearing aids are prescription devices 
restricted to patient use only upon the authorization of a practitioner 
licensed by law to administer or use the device; see 21 CFR 801.109 
(Prescription devices).
    Section 510(m) of the FD&C Act provides that FDA may exempt a class 
II device from the premarket notification requirements under section 
510(k), if FDA determines that premarket notification is not necessary 
to provide reasonable assurance of the safety and effectiveness of the 
device. For this type of device, FDA has determined that premarket 
notification is necessary to provide reasonable assurance of the safety 
and effectiveness of the device. Therefore, this device type is not 
exempt from premarket notification requirements. Persons who intend to 
market this type of device must submit to FDA a premarket notification, 
prior to marketing the device, which contains information about the 
tympanic membrane contact hearing aid they intend to market.

II. Environmental Impact, No Significant Impact

    We have determined under 21 CFR 25.34(b) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

III. Paperwork Reduction Act of 1995

    This final administrative order establishes special controls that 
refer to previously approved collections of information found in other 
FDA regulations. These collections of information are subject to review 
by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of 
information in part 807, subpart E, regarding premarket notification 
submissions have been approved under OMB control number 0910-0120, and 
the collections of information in 21 CFR part 801, regarding labeling 
have been approved under OMB control number 0910-0485.

IV. Reference

    The following reference is on display in the Division of Dockets 
Management (see ADDRESSES) and is available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also 
available electronically at http://www.regulations.gov. FDA has 
verified the Web site address, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

1. DEN150002: De novo Request per 513(f)(2) from EarLens 
Corporation, dated January 5, 2015.

List of Subjects in 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 part 
874 is amended as follows:

PART 874--EAR, NOSE, AND THROAT DEVICES

0
1. The authority citation for 21 CFR part 874 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.


0
2. Add Sec.  874.3315 to subpart D to read as follows:


Sec.  874.3315  Tympanic membrane contact hearing aid.

    (a) Identification. A tympanic membrane contact hearing aid is a 
prescription 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.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The patient contacting components must be demonstrated to be 
biocompatible.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use, and 
must include:
    (i) Mechanical integrity testing;
    (ii) Electrical and thermal safety testing;
    (iii) Software verification, validation, and hazard analysis;
    (iv) Reliability testing consistent with expected device life;
    (v) Electromagnetic compatibility testing; and
    (vi) Validation testing of device output and mechanical force 
applied to the tympanic membrane in a clinically appropriate model.
    (3) Clinical performance testing must characterize any adverse 
events observed during clinical use, and

[[Page 3327]]

demonstrate that the device performs as intended under anticipated 
conditions of use.
    (4) Professional training must include the ear impression 
procedure, correct placement, fitting, monitoring, care, and 
maintenance of the device.
    (5) Labeling must include the following:
    (i) A detailed summary of the adverse events and effectiveness 
outcomes from the clinical performance testing;
    (ii) Detailed instructions on how to fit the device to the patient;
    (iii) Instructions for periodic cleaning of any reusable 
components;
    (iv) Information related to electromagnetic compatibility; and
    (v) Patient labeling that includes:
    (A) A patient card that identifies if a patient has been fitted 
with any non-self- removable components of the device and provides 
relevant information in cases of emergency;
    (B) Information on how to correctly use and maintain the device;
    (C) The potential risks and benefits associated with the use of the 
device; and
    (D) Alternative treatments.

    Dated: January 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01090 Filed 1-20-16; 8:45 am]
 BILLING CODE 4164-01-P