The Scientific Concepts That Form The Basis For The Device; Significant Physical Characteristics; Prescription Use Of This Tsg Hearing Instrument; Important Notice For Prospective Sound Generator Users - ReSound SY312 User Manual

The scientific concepts that form the basis for the device

The TSG Module provides sound enrichment with the aim of surrounding the tinnitus sound with a neutral
sound which is easily ignored. Sound enrichment is an important component of most approaches to tin-
nitus management, such as Tinnitus Retraining Therapy (TRT). To assist habituation to tinnitus, this needs
to be audible. The ideal level of the TSG module, therefore, should be set so that it starts to blend with the
tinnitus, and so that you can hear both your tinnitus as well as the sound used.
In a majority of instances, the TSG module can also be set to mask the tinnitus sound, so to provide tem-
porary relief by introducing a more pleasant and controllable sound source.

Significant physical characteristics

Audio signal technology
Digital
Available sounds
White noise signal which can be shaped with the following configurations:
High-pass filter Low-pass filter
500 Hz 2000 Hz
750 Hz 3000 Hz
1000 Hz 4000 Hz
1500 Hz 5000 Hz
2000 Hz 6000 Hz
The white noise signal can be modulated in amplitude with an attenuation depth of up to 14dB.
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Prescription use of this TSG hearing instrument

The TSG module should be used as prescribed by your doctor, audiologist or hearing healthcare profes-
sional. In order to avoid permanent hearing damages, the maximum daily usage depends on the level of
the generated sound.
Should you develop any side effects from using the sound generator, such as dizziness, nausea, head-
aches, perceived decrease in auditory function or increase in tinnitus perception, you should discontinue
use of sound generator and seek medical evaluation.
The target population is primarily the adult population over 18 years of age. This product may also be used
with children 5 years of age or older. However, children and physically or mentally challenged users will re-
quire training by a doctor, audiologist, hearing healthcare professional or the guardian for the insertion and
removal of the hearing instrument containing the TSG module.

Important notice for prospective sound generator users

A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to
mask internal noises. It is also used as an aid in hearing external noises and speech.
Good health practice requires that a person with a tinnitus condition have a medical evaluation by a licensed
physician (preferably a physician who specializes in diseases of the ear) before using a sound generator.
Licensed physicians who specialize in diseases of the ear are often referred to as otolaryngologists, otolo-
gists or otorhinolaryngologists.
The purpose of medical evaluation is to assure that all medically treatable conditions that may affect tinnitus
are identified and treated before the sound generator instrument is used. The sound generator instrument is
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