Okara Rechargeable BTE Personal Sound Amplifier
This hearing device is an electronic wearable instrument
classified as a personal sound amplification products
(PSAPs) intended for the non-hearing impaired individuals
to amplify environmental sounds.
The device is subject to applicable provisions of the
Radiation Control for Health and Safety Act of 1968,
under which FDA regulates electronic products that emit
sonic vibrations, such as sound amplification equipment
described in 21 CFR 1000.15. Manufacturers of PSAPs must
report defects and adverse events and take other measures
described in 21 CFR Part 1003. Manufacturers of PSAPs must
also comply with the requirements to repurchase, repair, or
replace electronic products required under 21 CFR Part 1004.
You should contact the manufacturer or the reseller to
report any defects and adverse events; and to repurchase,
repair and replace.
You have our commitment to continue provide you with
support for using the
Okara Rechargeable BTE Personal
Sound Amplifier
you just bought. We encourage you
to let
us know your opinions on using the device and to share
your experience with us.
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