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About Start up Handling Options Warnings
Tinnitus
Additionals
If your Hearing Care Professional has
activated the sound generator Tinnitus
SoundSupport, please pay attention to
the below warnings.
• There are some potential concerns
associated with the use of any
sound generated by a tinnitus
management device. Among them
are the potential for worsening of
tinnitus and or a possible change in
hearing thresholds.
• Should you experience or notice
a change in hearing or tinnitus, or
any dizziness, nausea, headaches,
heart palpitations or possible skin
irritation at the point of contact with
the device, you should immediately
discontinue use of the device and
seek a consultation with a medical,
audiology, or other Hearing Care
Professional.
• As with any device, misuse of the
sound generator feature could
present some potentially harmful
effects. Care should be taken to
prevent the unauthorized use and to
keep the device out of the reach of
children and pets.
Warnings related to Tinnitus
• A Hearing Care Professional
should advise a prospective sound
generator user to consult promptly
with a licensed physician (preferably
an ear specialist) before using a
sound generator if the Hearing Care
Professional determines through
inquiry, actual observation, or review
or 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 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.
