Starkey Hearing Technologies CIC, Руководство по эксплуатации

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40 | Regulatory Information
CAUTION:
If set to the maximum output level and worn for periods of time
exceeding the recommendations below, the patient’s exposure to sound energy
has the potential to exceed noise exposure limits� This device is intended for use
for a maximum of sixteen (16) hours a day when set at the maximum output level�
For the Patient
A tinnitus therapy device is an electronic device intended to generate noise of
sufficient intensity and bandwidth to treat ringing in the ears� It can also be used
as an aid in hearing external sounds and speech�
Multiflex Tinnitus Technology is a tool to generate sounds� It is recommended
that this tool be used with appropriate counseling and/or in a tinnitus
management program to relieve patients suffering from tinnitus�
TINNITUS THERAPY CONCEPTS AND BENEFITS
Multiflex Tinnitus Technology can be used as a part of a tinnitus treatment
program�
Multiflex Tinnitus Technology plays a white noise through the hearing aid�
Multiflex Tinnitus Technology is programmed according to your hearing loss and
preference, and your hearing professional can adjust the settings of Multiflex
Tinnitus Technology to meet your needs�
Multiflex Tinnitus Technology may provide temporary relief of your tinnitus�
PRESCRIPTION USE ONLY
CAUTION:
Federal law restricts this device to sale by or on the order of
a doctor, audiologist or other hearing care practitioner licensed to dispense
hearing aids in your state�
The use of any sound generating tinnitus therapy device should be only on the
advice and in consultation with your audiologist or hearing care practitioner� Your
hearing 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 professional will also be able to offer the appropriate follow-up care�
It is important that you follow your hearing professional’s advice and direction
regarding such care�
WARNING:
There are some potential concerns associated with the use of
any sound generating tinnitus therapy device� Among them are the potential for
worsening of tinnitus, a possible change in hearing thresholds and possible skin
irritation at the point of contact with the device�
Multiflex Tinnitus Technology has been designed to minimize these concerns�
However, should you experience or notice any of the above conditions or any
dizziness, nausea, headaches or heart palpitations, you should immediately