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The sound generator instrument is a tool to generate sounds to be used with appropriate counselling and/
or in a tinnitus management program to relieve patients suffering from tinnitus.
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tsg warning to hearing healthcare professionals
A hearing healthcare 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
healthcare 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:
(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.
(vi) Audiometric air-bone gap equal to or greater than 15dB at 500 hertz (Hz), 1000 Hz, and 2000 Hz.
(vii) Visible evidence of significant cerumen accumulation or a foreign body in the ear canal.
(viii) 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. The user should not use the sound generator for more than eight (8)
hours a day when this is set below 90 dB SPL. Above that level, the device should not be used for more than
two (2) hours per day. In no case should the sound generator be worn at uncomfortable levels.
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Battery warning information
Batteries, although very small, contain dangerous substances, and should be disposed of carefully. This is
for the safety of you and the environment. Please note:
1. Do not attempt to recharge batteries (Zinc Air) which are not specifically designated as rechargeable
because they may leak or explode.
2. DO NOT attempt to dispose of batteries by burning them. Used batteries are harmful to the environment.
Please dispose of them according to local regulations or return them to your hearing care practitioner.
3. DO NOT place batteries in your mouth. Consult a physician immediately if a battery has been swallowed,
as they can be harmful to your health.
4. Keep batteries away from pets, children and individuals who are mentallly challenged.
5. Remove the batteries to prevent leakage when the hearing instruments are not in use for an extended
period of time.
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Hearing instrument expectations
A hearing instrument will not restore normal hearing and will not prevent or improve a hearing impairment
resulting from organic conditions. Consistent use of the hearing instrument is recommended. In most
cases, infrequent use does not permit you to attain full benefit from it.
The use of a hearing instrument is only part of hearing rehabilitation and may need to be supplemented by
auditory training and instructions in lip-reading.
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