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About Startup Handling Options Tinnitus Warnings More info
If your hearing care professional has
activated the sound generator Tinnitus
SoundSupport, please pay attention to
the following warnings.
There are some potential concerns
associated with the use of any sound
generated by a tinnitus management
device. Among them are the potential
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 consult a medical,
audiology, or other hearing care profes-
sional.
As with any device, misuse of the sound
generator feature may cause potentially
harmful effects. Care should be taken to
prevent unauthorised use and to keep
the device out of reach of children and
pets.
Maximum wearing time
Always follow the maximum wearing
time per day of the Tinnitus Sound-
Support advised by your hearing care
professional. Prolonged use may lead
to worsening of your tinnitus or of your
hearing loss.
Warnings related to Tinnitus
Instruct your patient accordantly and record your patient’s wearing
time in the table “Tinnitus SoundSupport: Limitation on use”, in
section “Limitation on use time”.
Maximum wearing time of Tinnitus SoundSupport
total dB(A)
SPL
Wearing time/hours per day
< 81 Full day
82 16
85 8
88 4
90 3
Ref. OSHA (Occupational Safety & Health Administration, U.S. department of Labour) / DIRECTIVE 2003/10/EC
on the minimum health and safety requirements regarding the exposure of workers to the risks arising from
physical agents (noise) / Occupational exposure to noise: evaluation, prevention and control – Special Report
S 64, WHO.
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