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Indications for Use
The hearing instrument is intended to amplify and transmit
sound to the ear and thereby compensate for mild to moderate
impaired hearing.
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.
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