Interton RD2CIC-HP, User Manual

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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 counseling
and/or in a tinnitus management programme to relieve patients suffering from tinnitus.
9.4
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Tinnitus Sound Generator warnings
1. Sound generators should be used only as advised by your doctor, audiologist, or hearing care
professional.
2. Sound generators are not toys and should be kept out of reach of anyone who might cause
themselves injury (especially children and pets).
3. Sound generators can be dangerous if improperly used.
9.4.1
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Tinnitus Sound Generator precautions
1. Should the user develop any side effects from using the sound generator, such as dizziness,
nausea, headaches, perceived decrease in auditory function or increase in tinnitus perception,
the user should discontinue use of the sound generator and seek medical evaluation.
2. The volume control is a feature in the TSG module used for adjusting the sound generator
output level. To prevent unintended usage by paediatric or physically or mentally disabled us-
ers, the volume control must be configured to only provide a decrease of the sound generator
output level.
3. Children and physically or mentally disabled users will require guardian supervision while wear-
ing the TSG hearing aid.
9.3.3
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Prescription use of a Tinnitus Sound Generator hearing aid
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 discon-
tinue 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 us-
ers will require training by a doctor, audiologist, hearing healthcare professional or the guardian for the
insertion and removal of the hearing instrument containing the TSG module.
9.3.4 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.