Current through Register Vol. 24-18, September 15, 2024
Federal Food and Drug Administration rules preempt Washington
state laws and rules for over-the-counter hearing aids; over-the-counter
hearing aids are not regulated under chapter 18.35 RCW or 246-828 WAC. Minimum
procedures in the fitting and dispensing of prescription hearing instruments
include:
(1) Obtaining case history
including:
(a) Documentation of
referrals.
(b) Historical
evaluation including inquiry regarding hearing loss, onset of loss, and any
associated symptoms including significant noise in the ears, vertigo, acute or
chronic dizziness, nausea, earaches, or other such discomfort which may
indicate the presence of medical illness. Specific inquiry should be made to
determine if hearing loss has been sudden or rapidly progressive in the past 90
days, if there has been any active drainage or infection in ears during the
past 90 days, and if there are any specific physical problems that may relate
to the use of a hearing instrument.
(2) Examining the ears to reasonably
determine if any of the following conditions exist:
(a) Impacted ear wax.
(b) Foreign body within the ear
canal.
(c) Discharge in the ear
canal.
(d) Presence of inflammation
or irritation of the ear canal.
(e)
Perforation of the ear drum.
(f)
Any other abnormality.
(3) Hearing testing to include the following:
(a) Hearing loss, or residual hearing, must
be established for each ear using pure tone threshold audiometry by air and
bone conduction with effective masking as required.
(b) Appropriate live voice or recorded speech
audiometry by ear phones to determine the following: Speech reception
threshold, most comfortable level, uncomfortable level, and word recognition
score.
(c) Hearing testing must be
conducted in compliance with WAC
246-828-080 and
246-828-090.
(d) When pure tone audiometry indicates an
air-bone gap of 15 decibels (dB) or more at 500, 1000, and 2000 hertz (Hz); the
presence of unilateral hearing loss; or any inconsistent audiometric findings,
the patient or client must be advised of the potential help available through
medical treatment. If the patient or client declines medical treatment, has
been appropriately treated previously, or has been advised against medical
treatment, the licensee must make an appropriate notation in the patient's or
client's record.
(e) In the event a
patient or client is referred to a licensee by an audiologist, otologist,
otolaryngologist, or by a hearing aid specialist licensed under chapter 18.35
RCW, and the audiometric results obtained within the previous six months are
provided to the licensee as a part of this referral, the applicable provisions
of WAC 246-828-100 are not required.
However, a confirmatory audiometric examination is
recommended.
(4) Medical
evaluation requirements: A hearing aid specialist or audiologist may not sell a
hearing instrument to a patient or client under the age of 18 years old unless
the prospective patient or client has presented a written statement signed by a
licensed physician that states that the patient's or client's hearing loss has
been medically evaluated and the patient or client may be considered a
candidate for a hearing instrument. The medical evaluation must have taken
place within the preceding six months.
(5) Selection and fitting of the hearing
instrument includes providing the patient or client:
(a) Information regarding the selection of
the most appropriate method and model for amplification for the needs of the
patient or client.
(b) The cost of
the recommended instruments and services.
(c) A custom made ear mold, when
applicable.
(d) Final fitting of
the hearing instrument to ensure physical and operational comfort.
(e) Adequate instructions and appropriate
post-fitting adjustments to ensure the most successful use of the hearing
instrument.
(6) Keeping
records for every patient or client in connection with the dispensing of a
hearing instrument. Cumulative records must be retained for all hearing
instruments dispensed for at least three years from the date the last hearing
instrument was dispensed to the patient or client. The records must be
available for the department inspection and must include:
(a) Patient's or client's case
history.
(b) Source of referral and
documents.
(c) Copies of any
contracts and receipts executed in connection with the fitting and dispensing
of each hearing instrument provided.
(d) A complete record of tests, test results,
and services provided.
(e) All
correspondence specifically related to the service given or the hearing
instrument(s) dispensed to the patient or client.
Statutory Authority:
RCW
18.35.161. 04-02-068, § 246-828-100,
filed 1/7/04, effective 2/7/04; 98-06-079, § 246-828-100, filed 3/3/98,
effective 4/3/98. Statutory Authority:
RCW
18.35.161(1) and (3).
95-19-017 § 246-828-100, filed 9/7/95, effective 10/8/95. Statutory
Authority:
RCW
18.35.161. 91-11-031 (Order 165B), recodified
as § 246-828-100, filed 5/8/91, effective 6/8/91; 89-04-017 (Order PM
818), § 308-50-130, filed 1/23/89; 84-19-018 (Order PL 478), §
308-50-130, filed 9/12/84; Order PL 159, § 308-50-130, filed
2/8/74.
