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 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 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 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 -13 dBm using GFSK transmission
modulation� The receiver section of the radio has a bandwidth of 1�5 MHz� They
also contain a radio transceiver utilizing Near Field Magnetic Induction operating
on 10�281 MHz with maximum induced magnetic field strength of -5 dBuA/m at
a measurement distance of 10 meters with 8-DPSK transmission modulation� The
receiver section of the NFMI radio has a bandwidth of 400 kHz�
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�
• Immunity to ESD levels of +/- 8 kV conducted discharge and +/- 15 kV
air discharge�
