Regulatory Information | 41
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 the 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�
