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The following additional information is provided in compliance with U.S. Food and Drug Administration (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 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 signifi cant 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 fi tting 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 prac-
tice 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 the medical evalua-
tion is to assure that all medically treatable conditions that may
affect hearing are identifi ed 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
aid. The physician will refer you to an audiologist or 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 fi t a hearing aid to your individual needs.
If you have reservations about your ability to adapt to amplifi cation,
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 a 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 qualifi ed by training
and experience to assist in the evaluation and rehabilitation of a
child with a hearing loss.
FDA informationFDA information
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