User's Manual

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.

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.

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)

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