Tsg Warnings; Tsg Precautions - ReSound BE70 User Manual

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TSG warnings

• Sound generators can be dangerous if improperly used.
• Sound generators should be used only as advised by your doctor, audiologist, or hearing healthcare
professional.
• Sound generators are not toys and should be kept out of reach of anyone who might cause themselves
injury (especially children and pets).
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TSG precautions

• 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.
• Children and physically or mentally challenged users will require guardian supervision while wearing the
TSG hearing instrument.
• The volume control is an optional feature in the TSG module used for adjusting the sound generator
output level. To prevent unintended usage by pediatric or physically or mentally challenged users, the
volume control must, if enabled, be configured to only provide a decrease of the sound generator output
level.
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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 90dB 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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