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FDA Information
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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 instrument.
The physician will refer you to an audiologist or hearing instrument
dispenser, as appropriate, for a hearing instrument evaluation.
The audiologist or hearing instrument dispenser will conduct a hearing
instrument evaluation to assess your ability to hear with and without a
hearing instrument. The hearing instrument evaluation will enable the
audiologist or dispenser to select and fit a hearing instrument 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 instrument dispensers now offer programs
that permit you to wear a hearing instrument for a period of time for
a nominal fee after which you may decide if you want to purchase the
hearing instrument.
Federal law restricts the sale of hearing instruments 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.
A hearing aid will not restore normal hearing and will not prevent or
improve a hearing impairment resulting from organic conditions. Use
of a hearing aid is only part of hearing habilitation and may need to be
supplemented by auditory training and instruction in lip reading. In most
cases infrequent use of a hearing aid does not permit a user to attain full
benefit from it.
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 qualified by training and experience
to assist in the evaluation and rehabilitation of a child with a hearing loss.
Starkey World Headquarters
6700 Washington Avenue South
Eden Prairie, MN 55344
Starkey European Headquarters
Wm. F. Austin House, Bramhall Technology Park
Pepper Road, Hazel Grove, Stockport SK7 5BX
United Kingdom
www.starkey.com
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