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14.4.1
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Tinnitus Sound Generator precautions
1. Should the user develop any side effects 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. The volume control is a feature in the TSG module used for adjusting the sound generator output
level. To prevent unintended usage by paediatric or physically or mentally disabled users, the vol-
ume control must be configured to only provide a decrease of the sound generator output level.
3. Children and physically or mentally disabled users will require guardian supervision while wearing
the TSG hearing aid.
14.4.2
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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.
6. Audiometric air-bone gap equal to or greater than 15 dB at 500 hertz (Hz), 1,000 Hz, and 2,000 Hz.
7. Visible evidence of significant cerumen accumulation or a foreign body in the ear canal.
8. Pain or discomfort in the ear.
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CAUTION:
The maximum output of the sound generator falls into the range that can cause
hearing loss according to OSHA regulations. In accordance with NIOSH recommendations, the
user should not use the sound generator for more than eight (8) hours a day when this is set to
a level of 85 dB SPL or above. When the sound generator is set to levels of 90 dB SPL or above
the user should not use the sound generator for more than two (2) hours per day. In no case
should the sound generator be worn at uncomfortable levels.
15
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General warnings
1. If a hearing aid is broken, do not use it.
2. Consult a hearing care professional:
• If you think there may be a foreign object in your ear canal
• If you experience skin irritation
• If excessive earwax accumulates with the use of the hearing aid
3. Different types of radiation, e.g. from NMR, MRI or CT scanners, may damage hearing aids. It is
recommended not to wear hearing aids during these or other similar procedures. Other types of
radiation, such as burglar alarms, room surveillance systems, radio equipment, mobile telephones,
contain less energy and will not damage hearing aids. However, they have the potential to mo-
mentarily affect the sound quality or temporarily create undesired sounds from hearing aids. Do
not wear hearing aids in mines, oil fields, or other explosive areas unless those areas are certified
for hearing aid use.