ReSound ONE User Manual page 44

Tinnitus Sound Generator 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), 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.
CAUTION: The maximum output of the sound generator falls into the range that can cause hearing loss
according to OSHA regulations. In compliance with NIOSH recommendations, the user should not use the
sound generator for more than eight (8) hours a day when it is set to a level of 85 dB SPL or above. When
the sound generator is set to levels of 90 dB SPL or above, the user should not use it for more than two (2)
hours per day. In no case should the sound generator be worn at uncomfortable levels.
44 Tinnitus Management