36
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 eects from using the sound generator, such as dizziness, nausea, head-
aches, perceived decrease in auditory function or increase in tinnitus perception, you should discontinue
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 sucient 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 otolaryngolo-
gists, otologists or otorhinolaryngologists.
The purpose of medical evaluation is to assure that all medically treatable conditions that may aect tin-
nitus are identified and treated before the sound generator instrument is used.
400618011US-17.01-Rev.A.indd 36 25-01-2017 09:59:14