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13.3.4 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, 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 counseling and/ or in a tinnitus management programme
to relieve patients suffering from tinnitus.
13.4
i
Tinnitus Sound Generator warnings
1. Sound generators can be dangerous if improperly used
2.
Sound generators should be used only as advised by your doctor,
audiologist, or hearing care professional
3. Sound generators are not toys and should be kept out of reach of
anyone who might cause themselves injury (especially children and
pets)
13.4.1
i
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. To prevent unintended usage by paediatric or physically or mentally
disabled users, the volume control must, if enabled, be configured to
only provide a decrease of the sound generator output level
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