54
code of federal regulations
(United States only)
21 C.F.R., part 801.420 - important notice
for prospective hearing instrument users
Good health practice 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
instrument. Licensed physicians who specialize in dis-
eases of the ear are often referred to as otolaryngolo-
gists, otologists, or otorhinolaryngologists. The pur-
pose of a medical evaluation is to assure that all med-
ically treated conditions that may affect hearing are
identified and treated before a unit is purchased.
Following the medical evaluation, the physician
should give you a written statement which states your
hearing loss has been medically evaluated, and that
you may be considered a candidate for a hearing
instrument. The physician should refer you to an
audiologist or hearing aid dispenser, as appropriate,
for a hearing instrument evaluation.
The audiologist or hearing aid dispenser will conduct a
hearing instrument evaluation to assess your ability to
hear with and without a hearing instrument. The eval-
uation will enable the audiologist or dispenser to select
and fit a unit best suited to your individual needs.
If you should have reservations about your ability to
adapt to amplification, you should inquire about the
availability of a trial rental or purchase-option program.
Many dispensers now offer programs that permit you
to wear the hearing instrument for a period of time
for a nominal fee after which you may decide if you
want to purchase that unit.
Federal law restricts the sale of hearing instruments to
those individuals who have not obtained a medical
evaluation from a licensed physician. Federal law per-
mits a fully informed adult to sign a waiver statement
declining the medical evaluation for religious or per-
sonal beliefs that preclude consultation with a physi-
cian. The exercise of such a waiver is not in your best
interest and its use is strongly discouraged.
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