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6.
Adjustment of the Tinnitus Sound Generator 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
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 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.
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