Regulatory Information | 45 44 | Regulatory Information
Required Hearing Aid Information
The following additional information is provided in compliance with U.S. Food
and Drug Administration (FDA) regulations:
WARNING TO HEARING AID DISPENSERS:
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:
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.
IMPORTANT NOTICE FOR PROSPECTIVE
HEARING AID USERS:
Good health practice requires that a person with hearing loss 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 otorhynolaringologists. 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.
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.
Some hearing aid users have reported a buzzing sound in their hearing aid
when they are using mobile phones, indicating that the mobile phone and
hearing aid may not be compatible. According to the ANSI C63.19 standard
(ANSI C63.19-2007 American National Standard Methods of Measurement
of Compatibility Between Wireless Communications Devices and Hearing
Aids), the compatibility of a particular hearing aid and mobile phone can be
predicted by adding the rating for the hearing aid immunity to the rating for
the mobile phone emissions. For example, the sum of a hearing aid rating
of 2 (M2/T2) and a telephone rating of 3 (M3/T3) would result in a combined
rating that equals at least 5 would provide “normal use”; a combined rating
of 6 or greater would indicate “excellent performance.” See your Quick Start
Guide included with your hearing aids for their exact M/T ratings.
CHILDREN WITH HEARING LOSS:
In addition to seeing a physician for a medical evaluation, a child with 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.
Required Multiflex Tinnitus Information for
Hearing Professionals
INDICATIONS FOR USE
The Multiflex Tinnitus Technology is a tool to generate sounds to be used in a
Tinnitus Management Program to relieve patients suffering from tinnitus. The
target population is primarily the adult population over 18 years of age.
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