36
|
Additional guidance 37
|
Additional guidance
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 hearing aid 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 instrument is an electronic instrument 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 care 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 hearing aid to sale by
or on the order of a doctor, audiologist or other hearing care
professional licensed to dispense hearing aids in your state.
The use of any sound generating tinnitus therapy instrument should
be only on the advice and in consultation with your audiologist
or hearing care professional. Your hearing care professional will
properly diagnose and fit the hearing aid 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.
CAUTION: If set to the maximum output level and worn for
periods of time exceeding the recommendations below, your exposure
to sound energy has the potential to exceed noise exposure limits.
You should not use your hearing aid for more than sixteen (16) hours
a day if your hearing aid is set at the maximum output level, nor should
you use your hearing aid if your hearing care professional has set the
hearing aid at levels that exceed your comfort level.
Intended use
Important Notice for Prospective Sound Generator Users
Good health practice requires that a person with tinnitus 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 otolaryngologists, otologists or otorhinolaryngologists.
The purpose of a 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.
TINNITUS TECHNICAL DATA
Multiflex Tinnitus Technology Maximum Output = 87 dB SPL (typical)
when measured in a 2cc coupler per ANSI S3.22 or IEC 60118-7.
WIRELESS TECHNICAL DESCRIPTION
Your hearing aids contain a radio transceiver utilizing Bluetooth Low
Energy wireless technology operating in the 2.4-2.4835 GHz frequency
band with a maximum effective radiated power of 0 dBm using GFSK
transmission modulation. The receiver section of the radio has a
bandwidth of 1.5 MHz.
This hearing aid model has been tested to, and has passed, the
following emissions and immunity tests:
• IEC 60601-1-2 radiated emissions requirements for a Group 1 Class
B device as stated in CISPR 11.
• RF radiated immunity at a field level of 10 V/m between 80 MHz and
2.7 GHz as well as higher field levels from communications devices
as stated in Table 9 of IEC 60601-1-2.
• Immunity to power frequency magnetic fields at a field level of 30
A/m, as well as proximity magnetic fields as defined in table 11 of
60601-1-2.
• Immunity to ESD levels of +/- 8 kV conducted discharge and +/- 15
kV air discharge.
The expected service life is 3 years.
WIRELESS NOTICES
FCC ID: EOA-24GENITELCH (left); EOA-24GENITERCH (right)
IC: 6903A-24GENITELCH (left); 6903A-24GENITERCH (right)
EU ADVERSE EVENT REPORTING
Any serious incident that has occurred in relation to your Starkey
device should be reported to your local Starkey representative
and the Competent Authority of the Member State in which you
are established. A serious incident is defined as any malfunction,
deterioration in the characteristics and/or performance of the device,
or inadequacy in the device user manual/ labeling which could lead
to the death or serious deterioration in the state of health of the user,
OR could do so upon recurrence.
Intended use
To Next Page
Loading...
