Regulatory Information
Regulatory Information
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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
Custom 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.
