c. History of sudden or rapidly progressive hearing loss within the previous 90 days
d. Acute or chronic dizziness
e. Unilateral hearing loss of sudden or recent onset within the previous 90 days
f. Visible evidence of significant cerumen accumulation or a foreign body in the ear canal
g. Pain or discomfort in the ear
3.
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.
4.
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 be configured to only provide a decrease of the sound
generator output level.
5.
Children and physically or mentally disabled users will require guardian supervision while
wearing the TSG hearing aid.
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 a 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 a minor.
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