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15.4.1 i Tinnitus Sound Generator precautions
1. Should the user develop any side eects from using the sound generator, such as dizziness,
nausea, headaches, perceived decrease in auditory function or increase in tinnitus perception, the
user should discontinue use of the sound generator and seek medical evaluation
2. To prevent unintended usage by pediatric or physically or mentally disabled users, the volume
control must, if enabled, be configured to only provide a decrease of the sound generator output
level
3. The volume control is an optional feature in the TSG module used for adjusting the sound genera-
tor output level.
4. Children and physically or mentally disabled users will require guardian supervision while wearing
the TSG hearing aid.
15.4.2 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
400738011US-17.07-Rev.B.indd 44 03-07-2017 13:51:31
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