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Prescription Use Only
Federal law restricts this device to sale by or on the order of a
doctor or hearing care professional licensed to dispense hearing
instruments in your state. The use of any sound generating
tinnitus therapy device should be only on the advice and in
consultation with your hearing care professional. Your hearing
care professional will properly diagnose and fit the device to
your personal needs and requirements. This should include its
use in a prescribed tinnitus treatment program. Your hearing
care professional will also be able to offer the appropriate
follow-up care. It is important that you follow your hearing care
professional’s advice and direction regarding such care.
WARNING
Risk of further impairment to the user’s hearing health.
There are some potential concerns associated with the use of any
sound generating tinnitus therapy device. Discontinue use and
seek medical evaluation if any of the following conditions occur:
• Chronic skin irritation on, near, or around the site of device
placement.
• Unusual side effects (e.g., dizziness, nausea, headaches, heart
palpitations).
• Perceived decrease in auditory function (e.g., decreased
loudness, speech not as clear).
WARNING
Risk of further impairment to the user’s hearing health.
The volume of the tinnitus noiser can be set to a level which could
lead to permanent hearing damage when used for a prolonged
period of time.
The tinnitus noiser should never be used at uncomfortable levels.
FOR HEARING CARE PROFESSIONALS
Indications for Use
The tinnitus noiser is a tool to generate sounds to be used in a
tinnitus management program to relieve patients suffering from
tinnitus. The target population is primarily the adult population
over 21 years of age. The tinnitus noiser is targeted for healthcare
professionals treating patients suffering from tinnitus, as well as
conventional hearing disorders. The fitting of the tinnitus noiser
should be done by a hearing care professional participating in a
tinnitus management program.
Device Description
The tinnitus noiser is a software function that generates sound
which is programmed into a hearing instrument. Depending on
the type of hearing instrument, the hearing instrument may be
used in up to three modes of operation: as a hearing instrument,
as a tinnitus treatment device, or as a hearing instrument and
tinnitus treatment device.
When enabled, the tinnitus noiser generates the sound and
allows a patient’s hearing care professional to design and
program appropriate settings for an individually prescribed sound
treatment plan. The treatment plan should be used in a tinnitus
management program for relief of tinnitus.
The tinnitus noiser generates a broadband noise signal that
varies in frequency and amplitude. These characteristics are
adjustable by the hearing care professional and are specific to the
prescribed therapy designed by the professional for the patient’s
needs and comfort. The patient may have some control of the
level or volume of the signal and the patient should discuss this
adjustment as well as his or her comfort level and sound of the
signal with their hearing care professional.
