Starkey Hearing Technologies BTE 13, Manual

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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:
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.