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FDA information
Good health practice requires that a person with a hearing loss to have a medical
evaluation by a licensed physician (preferably a physician who specializes in
diseases of the ear) before purchasing a hearing aid. Licensed physicians who
specialize in diseases of the ear are often referred to as otolaryngologists,
otologists or otorhinolaryngologists.
The purpose of 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 a
Hearing Healthcare Professional for a hearing aid evaluation.
T
he 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 healthcare provider to select and fit a hearing aid
to your individual needs.
Notice to hearing healthcare providers
A hearing aid dispenser should advise a prospective hearing aid user to consult
promptly with a licensed physician (preferably an ear specialist) before
dispensing a hearing aid. If the hearing aid dispenser determines through inquiry,
actual observation, or review of any other available information concerning the
prospective user, that the prospective user has any of the following conditions,
then consult a physician.
I
f 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 Healthcare Professionals 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.
F
ederal 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.
