Operation Manual

49
FDA Information
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 recommendations
below, 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 care
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.
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.