User's Manual

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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