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assure that all medically treatable conditions that may affect hearing are
identified and treated before the hearing instrument 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 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 . 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 .
NuEar
6769 Mesa Ridge Road
Suite 100
San Diego, CA 92121
800 .626 .8327
858.450.9972
www.NuEar.com
FDA Information
Summary of Contents for rhapsody 1600
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