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Prescription use of this Tsg hearing instrument
The TSG module should be used as prescribed by your doctor, audiologist or hearing healthcare profes-
sional. In order to avoid permanent hearing damages, the maximum daily usage depends on the level of
the generated sound.
Should you develop any side effects from using the sound generator, such as dizziness, nausea, head-
aches, perceived decrease in auditory function or increase in tinnitus perception, you should discontinue
use of sound generator and seek medical evaluation.
The target population is primarily the adult population over 18 years of age. This product may also be used
with children 5 years of age or older. However, children and physically or mentally challenged users will re-
quire training by a doctor, audiologist, hearing healthcare professional or the guardian for the insertion and
removal of the hearing instrument containing the TSG module.
important notice for prospective sound generator users
A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to
mask internal noises. It is also used as an aid in hearing external noises and speech.
Good health practice requires that a person with a tinnitus condition have a medical evaluation by a licensed
physician (preferably a physician who specializes in diseases of the ear) before using a sound generator.
Licensed physicians who specialize in diseases of the ear are often referred to as otolaryngologists, otologists
or otorhinolaryngologists.
The purpose of medical evaluation is to assure that all medically treatable conditions that may affect tinnitus
are identified and treated before the sound generator instrument is used.
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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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