Safety and health information 1
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Intended use
The Lexie B2 Hearing Aids, Powered by Bose, are
a pair of OTC user- tted wireless air conduction
hearing aids intended for use by individuals 18 years
and older with perceived mild to moderate hearing
impairment.
Indications for use
Lexie B2 Hearing Aids, Powered by Bose, are
intended to amplify sound for individuals 18 years
of age or older with perceived mild to moderate
hearing impairment. They are adjusted by the
user to meet the user’s hearing needs. No pre-
programming or hearing test is necessary. The
device is intended for over-the-counter sale and
use without the assistance of a hearing care
professional.
Clinical data
In a clinical study, people with mild to moderate
hearing impairment generally experienced similar
hearing benet, and were more satised, when