Operation Manual

37
FDA INFORMATION
the ear are often referred to as otolaryngologists, otologists,
or otorhinolaryngologists. The purpose of the 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 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 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 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
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Pepper Road, Hazel Grove, Stockport SK7 5BX
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