User guide

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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 therapy feature can be set to a level
which could lead to permanent hearing damage when used for a
prolonged period of time.
The tinnitus therapy feature should never be used at
uncomfortable levels.
FOR HEARING CARE PROFESSIONALS
Indications for Use
The tinnitus therapy feature 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 therapy feature
is targeted for healthcare professionals treating patients suffering
from tinnitus, as well as conventional hearing disorders. The
fitting of the tinnitus therapy feature should be done by a hearing
care professional participating in a tinnitus management program.
Device Description
The tinnitus therapy feature 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 therapy feature 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 therapy feature 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.
WARNING
Risk of further impairment to the user’s hearing health.
The volume of the tinnitus therapy signal can be set to a level
which could lead to permanent hearing damage when used for a
prolonged period of time.
Should the tinnitus therapy signal be set to such a level in the
hearing instrument, advise the user of the maximum amount of
time per day he or she should use the tinnitus therapy signal. For
example, occupational safety guidelines restrict continuous noise
exposure of 80dBA SPL to 8 hours per day. The tinnitus therapy
signal should never be used at uncomfortable levels.