• Discontinue use of the sound generator and consult promptly with a licensed physician if you
experience 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 500Hertz (Hz), 1000Hz, and
2000Hz.
7. Visible evidence of significant cerumen accumulation or a foreign body in the ear canal.
8. Pain or discomfort in the ear.
• Discontinue use of the sound generator and consult promptly with your hearing care professional, if
you experience changes in the tinnitus perception, discomfort, or interrupted speech perception, while
using the tinnitus sound generator.
• The volume control is a feature in the TSG module used for adjusting the sound generator output level.
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.
• Children, and physically or mentally disabled users will require guardian supervision while wearing the
TSG hearing aid.
• 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 a minor.
Tinnitus Management 51
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