6. Adjustment of the Tinnitus Breaker Pro settings, using a smartphone app, should only be performed by the
parent or legal guardian in cases where the user is minor. Use of the Beltone Remote Care for remote
settings of the tinnitus sound generator, should only be performed by the parent or legal guardian in cases
where the user is minor.
Tinnitus Breaker Pro warning to hearing care professionals
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 15 dB at 500 Hertz (Hz), 1,000 Hz, and 2,000 Hz.
7. Visible evidence of significant cerumen accumulation or a foreign body in the ear canal.
8. Pain or discomfort in the ear.
CAUTION:
The maximum output of the sound generator falls into the range that can cause hearing loss
according to OSHA regulations. In accordance with NIOSH recommendations, the user should not use
the sound generator for more than eight (8) hours a day when this is set to a level of 85 dB SPL or
40
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