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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.
of M3. 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.
36
This hearing aid has a cell phone immunity rating
A hearing aid dispenser
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