• Use of the ReSound Assist for remote settings of the tinnitus sound generator should only be
performed by the parent or legal guardian in cases where the user is a minor.
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 15dB at 500 Hertz (Hz), 1000 Hz, and 2000Hz.
7. Visible evidence of significant cerumen accumulation or a foreign body in the ear canal.
8. Pain or discomfort in the ear.
Tinnitus Management 53
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