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14.1 Indication for use of the TSG module
The Tinnitus Sound Generator Module is a tool to generate sounds to be used in a Tinnitus Management
Program to relieve patients suffering from Tinnitus. The target population is primarily the adult popula-
tion over 18 years of age. This product may also be used with children 5 years of age or older.
The Tinnitus Sound Generator module is targeted for healthcare professionals, which are treating pa-
tients suffering from Tinnitus, as well as conventional hearing disorders. The fitting of the Tinnitus Sound
Generator module must be done by a hearing professional participating in a Tinnitus Management
Program.
14.2 User instructions for the TSG module
14.2.1 Description of device
The Tinnitus Sound Generator (TSG) Module is a software tool that generates sounds to be used in tin-
nitus management programmes to relieve suffering from tinnitus.
14.2.2 Explanation of how the device functions
The TSG module is a frequency and amplitude shaped white-noise generator. Noise signal level and
frequency characteristics can be adjusted to the specific therapeutic needs as determined by your doctor,
audiologist or hearing care professional.
Your doctor, audiologist or hearing care professional can modulate the generated noise with the purpose
of making it more pleasant. The noise can then resemble, for example, breaking waves on a shore.
Modulation level and speed can also be configured to your likes and needs. An additional feature can
be enabled by your hearing care professional that allows you to select predefined sounds that simulate
sounds from nature, such as breaking waves or running water.
If you have two wireless hearing aids that support ear-to-ear synchronization, this functionality can be
enabled by your hearing care professional. This will cause the Tinnitus Sound Generator to synchronize
the sound in both hearing aids.
If your tinnitus troubles you only in quiet environments, your doctor, audiologist or hearing care profes-
sional can set the TSG Module so that it becomes audible exclusively in such surroundings. The overall
sound level can be adjusted via a volume control. Your doctor, audiologist or hearing care professional
will review with you the need for having such a control.
For hearing aids where ear-to-ear synchronization is enabled your hearing care professional can also
enable environmental monitoring synchronization so that the TSG noise level is automatically adjusted
simultaneously in both hearing aids dependent on the background sound level. Additionally since the
hearing aid has a volume control then the background noise level monitored by the hearing aid and the
volume control can be used simultaneously to adjust the generated noise level in both hearing aids.
