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Interton RD 61 - 9.6 Prescription use of a Tinnitus Sound Generator (TSG) hearing aid; 9.7 Important notice for prospective sound generator users

Interton RD 61
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9.5.2 Available sounds
White noise signal which can be shaped with the following configurations:
The white noise signal can be modulated in amplitude with an attenuation depth of up to 14dB.
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
9.6 Prescription use of a Tinnitus Sound Generator (TSG) hearing aid
The TSG module should be used as prescribed by your doctor, audiologist or hearing care professional.
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 discon-
tinue use of the 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 disabled users
will require training by a doctor, audiologist, hearing care professional or the guardian for the insertion
and removal of the hearing aid containing the TSG module.
9.7 Important notice for prospective sound generator users
A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and band-
width 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 otolaryn-
gologists, otologists 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 a tool to generate sounds to be used with appropriate counselling
and/or in a tinnitus management programme to relieve patients suffering from tinnitus.

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