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FdA 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.
Special care should be exercised in selecting and fitting a hearing
aid whose maximum sound pressure level exceeds 132 decibels
because there may be risk of impairing the remaining hearing of
the hearing aid user.
rF immunitY rAting.
These hearing aids have a cell phone
immunity rating of M2/T2. For your cell phone to be compatible
with these hearing instruments, the cell phone needs an immunity
rating of M3/T3 or higher. Please consult your cell phone
specifications for your 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
