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Warning to hearing care professionals
(to comply with the U.S. Food and Drug
Administration (FDA) regulations)
Hearing care professionals 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 care
professional 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. 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.
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 care
professional, as appropriate, for a hearing aid evaluation.
The audiologist or hearing care professional will conduct a hearing aid
evaluation to assess your degree of hearing. 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 care professionals 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 not obtained a medical evaluation from a licensed physician.
Federal law permits a fully informed adult to sign a waiver statement
declining the nominal fee after which you may decide if you want to
purchase the hearing aid or medical evaluation for religious or personal
beliefs that preclude consultation with a physician. The exercise of such
waiver is not in your best 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 hearing loss.