User's Manual

Safety and health information 1
15
Intended use
The Lexie B1 Hearing Aids, Powered by Bose, are
a pair of OTC user-tted air conduction hearing
aids intended for use by individuals 18 years and
older with a perceived mild to moderate hearing
impairment. This allows the user to set up and
control their hearing aids through wireless
connection with an app on their mobile phone.
Indications for use
The Lexie B1 Hearing Aids, Powered by Bose,
are intended to amplify sound for individuals 18
years of age or older with a 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