Sonitus Medical?Shanghai?Co., ltd.

Address:Floor 5, Bldg. 11 & Floor 4-5, Bldg. 7, 500 Furonghua Rd, Pudong, Shanghai,shanghai,CN

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Hearing Aid, Bone Conduction (LXB) (1)

Premarket Exempt

Clear

SoundBite - 06972667660313 Catalog Number :

Device Description : The SoundBite Hearing System by Sonitus Medical consists of two main components; The SoundBite Hearing System by Sonitus Medical consists of two main components; a behind the ear (BTE) microphone unit and an in the mouth (ITM) hearing device. Accessories include a system charger and programming software. The BTE uses a digital signal processor to process the sound and a wireless chip to transmit the signals to the hearing device worn in the mouth. The ITM hearing device in turn creates imperceptible vibrations using a piezoelectric actuator that are sent via the teeth, through the skull bones, and ultimately to the cochleae.

Device Class : 2

Duns Number: 544488215

Premarket Exempt : No

Product Code : LXB

Prescription Use : No

Device Count : 1

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