WARNING TO THE HEARING CARE PROFESSIONAL:
A hearing care professional should advise a prospective sound generator user to consult promptly
with a licensed physician (preferably an ear specialist) before getting a sound generator if the
hearing care professional 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:
1.
Visible congenital or traumatic deformity of the ear.
2.
History of active drainage from the ear within the previous 90 days.
3.
History of sudden or rapidly progressive hearing loss within the previous 90 days.
4.
Acute or chronic dizziness.
5.
Unilateral hearing loss of sudden or recent onset within the previous 90 days.
6.
Audiometric air-bone gap equal to or greater than 15dB at 500 hertz (Hz), 1000 Hz, and
2000 Hz
7.
Visible evidence of significant cerumen accumulation or a foreign body in the ear canal.
8.
Pain or discomfort in the ear.
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Tinnitus Management
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Страница 79: ...Complies with IMDA Standards DA105282 Complies with IMDA standards Regulatory information 79...
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Страница 87: ...Notes Additional information 87...