patient may have some control of the level or volume of the signal and the
patient should discuss this adjustment as well as his or her comfort level
and sound of the signal with their hearing care professional.
WARNING
Risk of further impairment to the user's hearing health.
The volume of the tinnitus noiser can be set to a level which could lead to
permanent hearing damage when used for a prolonged period of time.
Should the tinnitus noiser be set to such a level in the hearing instrument,
advise the user of the maximum amount of time per day he or she should
use the tinnitus noiser. For example, occupational safety guidelines restrict
continuous noise exposure of 80dBA SPL to 8 hours per day. The tinnitus
noiser should never be used at uncomfortable levels.
WARNING
Risk of further impairment to the user's hearing health.
A hearing care professional should advise a prospective tinnitus
noiser user to consult promptly with a licensed physician (preferably
an ear specialist) before using the tinnitus noiser if the hearing care
professional determines through inquiry, actual observation, or review or
any other available information concerning the prospective user that the
prospective user has any of the following conditions:
i. Visible congenital or traumatic deformity of the ear.
ii. History of active drainage from the ear within the previous 90 days.
iii. History of sudden or rapidly progressive hearing loss within the
previous 90 days.
iv. Acute or chronic dizziness.
v. Unilateral hearing loss of sudden or recent onset within the
previous 90 days.
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