gudid Primary ID: G3

SoundBite (UDI G3)

Manufactured by Sonitus Medical?Shanghai?Co., ltd.

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The SoundBite (Model/Catalog Number: G3) is a medical device manufactured by Sonitus Medical?Shanghai?Co., ltd.. This product is indexed under FDA Product Code / Category Classification LXB within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: G3
Product Code / EMDN: LXB
Device Name: 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.
Database Sync Date: 2026-08-09 09:06:41

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of SoundBite?

The registered manufacturer of record for SoundBite is Sonitus Medical?Shanghai?Co., ltd..

What is the Primary UDI-DI identifier for SoundBite?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is G3.

What classification code is assigned to this device?

This device is registered under product classification code LXB.

Similar Classification Devices (LXB)

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