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9. FDA regulations
Warning to hearing aid dispensers
A hearing aid dispenser should advise a prospective
hearing aid user to consult promptly with a licensed
physician (preferably an ear specialist) before
dispensing a hearing aid if the hearing aid dispenser
determines through inquiry, actual observation,
or review of any other available information
concerning the prospective user, that the prospec-
tive user has any of the following conditions:
(i)
Visible congenital or traumatic deformity
of the ear.
(ii)
History of active drainage from the ear
within the previous 90 days.
(iii)
History of sudden or rapidly progressive
hearing loss within the previous 90 days.
(iv)
Acute or chronic dizziness.
(v)
Unilateral hearing loss of sudden or recent
onset within the previous 90 days.
(vi)
Audiometric air-bone gap equal to or greater
than 15 decibels at 500 hertz (Hz), 1,000 Hz,
and 2,000 Hz.
(vii)
Visible evidence of significant cerumen
accumulation or a foreign body in the ear
canal.
(viii)
Pain or discomfort in the ear. Special care
should be exercised in selecting and fitting
a hearing aid whose maximum sound pressure
level exceeds 132 decibels because there
may be risk of impairing the remaining hearing
of the hearing aid user. (This provision is
required only for those hearing aids with a
maximum sound pressure capability greater
than 132 decibels [dB].)
Important notice for prospective hearing aid
users
Good health practice requires that a person with a
hearing loss have a medical evaluation by a licensed
physician (preferably a physician who specializes
in diseases of the ear) before purchasing a hearing
aid. Licensed physicians who specialize in diseases
of the ear are often referred to as otolaryngolo-
gists, otologists or otorhinolaryngologists.
The purpose of medical evaluation is to assure that
all medically treatable conditions that may affect
hearing are identified and treated before the
hearing aid is purchased.
Following the medical evaluation, the physician will
give you a written statement that states that your
hearing loss has been medically evaluated and that
you may be considered a candidate for a hearing
