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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. 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 85db SPL or above.
When the sound generator is set to levels of 90db SPL or above the user should not use the sound genera-
tor for more than two (2) hours per day. In no case should the sound generator be worn at uncomfortable
levels.
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