Regulatory Information | 29
28 | Regulatory Information
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
discontinue use of the device and seek a consultation with a medical, audiology
or other hearing professional�
As with any device, misuse of the tinnitus therapy device could present some
potentially harmful effects� Care should be taken to prevent unauthorized use and
to keep the device out of the reach of children and pets�
CAUTION:
If set to the maximum output level and worn for periods
of time exceeding the following recommendations, your exposure to sound
energy has the potential to exceed noise exposure limits� You should not use
your hearing device for more than sixteen (16) hours a day if your device is set
at the maximum output level, nor should you use your device if your hearing
professional has set the device 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�
EMC COMPLIANCE
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 and proximity magnetic fields as stated in Table 11 of IEC
60601‑1‑2�
• Immunity to ESD levels of +/‑ 8 kV conducted discharge and +/‑ 15 kV
air discharge�
FCC NOTICE
This device complies with part 15 of the FCC rules and with ISED Canada’s
license‑exempt RSS standard(s)� Operation is subject to the following two
conditions: (1) This device may not cause harmful interference, and (2) this
device must accept any interference received, including interference that
may cause undesired operation of the device�
Note: The manufacturer is not responsible for any radio or TV interference
caused by unauthorized modifications to this equipment� Such modifications
could void the user’s authority to operate the equipment�
