Pallas WB-215 User Instructions - Regulatory Compliance:
WEARING THE DEVICE (cont’d):
In below is the diagram showing a properly worn Pallas
WB-215 digitally operated rechargeable BTE Personal Sound
Amplifier in the left ear.
Regulatory compliance:
This rechargeable BTE ear hearing device is an electronic wearable instrument is
defined by U.S. Food & Drug Administration as the personal sound amplification
products (PSAPs) intended for the non-hearing impaired individuals to amplify
environmental sounds, such as for recreational activities. The device is subject to
applicable provisions of the Radiation Control for Health and Safety Act of 1968,
under which U.S. Food & Drug Administration regulates electronic products that
emit sonic vibrations, such as sound amplification equipment described in 21
CFR 1000.15. All manufacturers of PSAPs must report defects and adverse events
and take other measures described in 21 CFR Part 1003, must also comply with
the requirements to repurchase, repair, or replace electronic products required