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Intended Use
The Soundwave Hearing Sontro
®
Hearing Aids are a pair of self-tting wireless
air conduction hearing aids intended for use by individuals 18 years and older
with perceived mild to moderate hearing impairment. The devices require the
otoTune™ app to administer a hearing test to program the devices to a user’s
hearing threshold. Once complete, a user can control and customize their
devices using the app to meet their hearing needs. The device is intended
for direct-to-consumer sale and use without the assistance of a hearing care
professional.
Indications for Use
The Soundwave Hearing Sontro Hearing Aids are a pair of self-tting wireless air
conduction hearing aids intended for use by individuals 18 years and older with
perceived mild to moderate hearing impairment.
The devices require the otoTune
®
app to administer a hearing test to program
the devices to a user’s hearing threshold. Once complete, a user can control and
customize their devices using the app to meet their hearing needs. The device
is intended for direct-to-consumer sale and use without the assistance of a
hearing care professional.
Safety and Health Information
