Regulatory Information | 49
48 | Regulatory Information
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 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 hearing aid 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 instrument 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 hearing aid 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 instrument 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 hearing aid
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
discontinue use of the hearing aid and seek a consultation with a medical,
audiology or other hearing professional
As with any hearing aid, misuse of the tinnitus therapy instrument could present
some potentially harmful effects Care should be taken to prevent the unauthorized
use and to keep the hearing aid out of the reach of children and pets
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
professional has set the hearing aid at levels that exceed your comfort level
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 S322 or IEC 60118-7
WIRELESS TECHNICAL DESCRIPTION
Your hearing aids contain a radio transceiver utilizing Bluetooth
Low Energy
wireless technology operating in the 24-24835 GHz frequency band with
a maximum effective radiated power of -13 dBm using GFSK transmission
modulation The receiver section of the radio has a bandwidth of 15 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 27 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
• Immunity to ESD levels of +/- 8 kV conducted discharge and +/- 15 kV
air discharge
