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Drukuj stronęFDA statements
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 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), 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 .
Important notice for prospective hearing
aid users
Good health practice requires that a person with 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 .
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
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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 hearing loss .
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