User Manual

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INDICATIONS FOR USE
The hearing device is intended to amplify and transmit sound to the ear
and thereby compensate for mild to severe high-frequency hearing loss
WARNING TO HEARING DEVICE DISPENSERS
A hearing device dispenser should advise a prospective hearing device
user to consult promptly with a licensed physician (preferably an ear
specialist) before dispensing a hearing device if the hearing device
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.