GN Danalogic Ambio BRIE - Tinnitus Sound Generator Module; Intended Use for TSG Module; Description of the Device; Explanation of How the Device Functions

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If you have two wireless hearing aids that support ear-to-ear
synchronizaon this funconality 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 nnitus troubles you only in quiet environments, your doctor,
audiologist or hearing care professional can set the TSG module so that it
becomes audible exclusively in such surroundings. The overall sound level
can be adjusted via an oponal 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 synchronizaon is enabled, your
hearing care professional can also enable environmental monitoring
synchronizaon so that the TSG noise level is automacally adjusted
simultaneously in both hearing aids dependent on the background
sound level. Addionally, if 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.
13.2.3 Thesciencconceptsthatformthebasisforthedevice
The TSG module provides sound enrichment with the aim of surrounding
the nnitus sound with a neutral sound, which is easily ignored. Sound
enrichment is an important component of most approaches to nnitus
management, such as Tinnitus Retraining Therapy (TRT).
To assist habituaon to nnitus, this needs to be audible. The ideal level of
the TSG module, therefore, should be set so that it starts to blend with the
nnitus, and so that you can hear both your nnitus as well as the sound
used.
In a majority of instances, the TSG module can also be set to mask the
nnitus sound, so to provide temporary relief by introducing a more
pleasant and controllable sound source.
13 Tinnitus Sound Generator module
13.1 Intended use for TSG module
Your hearing aid includes the Tinnitus Sound Generator (TSG) module, a
tool for generang sounds to be used in nnitus management programmes
to relieve suering from nnitus.
The TSG can generate sounds adjusted to the specic therapeuc needs
and your personal preference as determined by your doctor, audiologist, or
hearing care professional.
13.2 User instrucons for the TSG module
13.2.1Descriponofthedevice
The Tinnitus Sound Generator (TSG) Module is a soware tool that
generates sounds to be used in nnitus management programmes to
relieve suering from nnitus.
Depending on the selected hearing aid programme and the environment
you are in, you will somemes hear the therapeuc sound resembling a
connuous or uctuang noise.
13.2.2 Explanaonofhowthedevicefuncons
The TSG module is a frequency and amplitude shaped white-noise
generator. Noise signal level and frequency characteriscs can be adjusted
to the specic therapeuc 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, crashing waves on a shore.
Modulaon level and speed can also be congured to your likes and needs.
An addional feature can be enabled by your hearing care professional that
allows you to select predened sounds that simulate sounds from nature,
such as breaking waves or running water.