Fda Information; Required Information - Microtech Axio Operation Manual

FDA Information

Required Information

The following additional information is provided in compliance with U.S.
Food and Drug Administration (FDA) regulations:
WARNING TO HEARING AID DISPENSERS.
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.
RF IMMUNITY LEVEL. This hearing aid has a cell phone immunity rating
of M3/T3. A hearing aid compatible cell phone must carry a rating of M2
or higher to work with this hearing aid. Please consult your cell phone
specification for the cell phone immunity rating.
IMPORTANT NOTICE FOR PROSPECTIVE HEARING AID 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
aid. 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 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.
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A hearing aid dispenser
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.
CHILDREN WITH HEARING LOSS.
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.
© 2009 Micro-Tech Hearing Instruments
6425 Flying Cloud Drive
Eden Prairie, MN 55344
800.745.4327
www.mthearing.com
FDA Information
In addition to seeing a physician for
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