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Required Information
The following additional information is provided in compliance with
U.S. Food and Drug Administration (FDA) regulations:
WARNING TO HEARING INSTRUMENT DISPENSERS.
A hearing instrument dispenser should
advise a prospective hearing instrument user to consult promptly with a licensed physician (preferably
an ear specialist) before dispensing a hearing instrument if the hearing instrument 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:
i. Visible congenital or traumatic deformity of the ear.
ii. History of active drainage from the ear within the previous 90 days.
iii. History of sudden or rapidly progressive hearing loss within the previous 90 days.
iv. Acute or chronic dizziness.
v. Unilateral hearing loss of sudden or recent onset within the previous 90 days.
vi. Audiometric air-bone gap equal to or greater than 15 decibels at 500 Hertz (Hz), 1,000 Hz and 2,000 Hz.
vii. Visible evidence of significant cerumen accumulation or a foreign body in the ear canal.
viii. Pain or discomfort in the ear.
Special care should be exercised in selecting and fitting a hearing instrument whose maximum sound
pressure level exceeds 132 decibels because there may be risk of impairing the remaining hearing of
the hearing instrument user.
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 diseases of the ear are often referred to as otolaryngologists,
otologists, or otorhynolaryngologists. 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
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. Use of a hearing aid is only part of hearing
habilitation and may need to be supplemented by auditory training and instruction in lip reading.
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.
FDA Information
FDA Information
