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Warning to hearing aid dispensers (to comply with the U.S. Food
and Drug Administration (FDA) regulations)
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 or any
other available information concerning the prospective user, that the
prospective 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), 1000 Hz and 2000 Hz.
vii. Visible evidence of significant cerumen accumulation or a foreign
body in the ear canal.
viii. Pain or discomfort in the ear.
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
otolaryngologists,
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.
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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
aid. The physician will refer you to an audiologist or a hearing aid
dispenser, as appropriate, for a hearing aid evaluation.
The audiologist or hearing aid dispenser will conduct a hearing aid
evaluation to assess your ability to hear with and without a hearing
aid. The hearing aid evaluation will enable the audiologist or
dispenser to select and fit a hearing aid to your individual needs.
If you have reservations about your ability to adapt to amplification,
you should inquire about the availability of a trial-rental or purchase-
option program. Many hearing aid dispensers now offer programs that
permit you to wear a hearing aid for a period of time for a nominal fee
after which you may decide if you want to purchase the hearing aid.
Federal law restricts the sale of hearing aids to those individuals who
have obtained a medical evaluation from a licensed physician. Federal
law permits a fully informed adult to sign a waiver statement declining
the medical evaluation for religious or personal beliefs that preclude
consultation with a physician. The exercise of such a waiver is not in
your best health interest and its use is strongly discouraged.
Children with hearing loss
In addition to seeing a physician for a medical evaluation, a child with
hearing loss should be directed to an audiologist for evaluation and
rehabilitation since hearing loss may cause problems in language
development and the educational and social growth of a child. An
audiologist is qualified by training and experience to assist in the
evaluation and rehabilitation of a child with a hearing loss.
