User's Guide

level of the generated sound.
Should you develop any side effects from using the sound generator, such as dizziness, nausea,
headaches, 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 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.
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.
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