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 the
sound generator and seek medical evaluation.
Target population
The target population is primarily the adult population over 18 years of age. This product may also be used with
children 12 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 TBP 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 one 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 counselling and/or in a
tinnitus management program to relieve patients suffering from tinnitus.
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Tinnitus Management
Summary of Contents for Imagine Custom
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