SoundBite
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…
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.
Who Else Makes It
Concentrated in Guangdong (2), Henan (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Zdeer Technology (Henan) Co., Ltd. | Xuchang | Henan | Remanufacturer | 9 |
| Shenzen Magnet Technology Co., Ltd. | Shenzen | Guangdong | Manufacturer | 2 |
| Sonitus Medical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Specification developer | 1 |
Record
| Listed by | Sonitus Medical (Shanghai) Co., Ltd., China |
|---|---|
| FDA product code | LXB |
| Device type | Hearing Aid, Bone Conduction |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3302 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K100649 |
| Record published | 2021-04-01 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Latex | Labelled latex-free |
| Label carries | manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G3 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ponto | Oticon Medical AB | 172 |
| Hearing Aid, Bone Conduction | BHM-Tech Produktionsgesellschaft m.b.H. | 99 |
| Baha | Cochlear Bone Anchored Solutions AB | 98 |
| Otomag™ Attract™ Magnetic Spacer | Medtronic Xomed, Inc. | 23 |
| Attract™ | Medtronic Xomed, Inc. | 22 |
| Otomag™ Alpha 2 Sound Processor | Medtronic Xomed, Inc. | 21 |
| Hearing Aid, Bone Conduction | Medtronic Xomed, Inc. | 21 |
| contact | BHM-Tech Produktionsgesellschaft m.b.H. | 21 |
| contact mini | BHM-Tech Produktionsgesellschaft m.b.H. | 12 |
| Otomag™ Alpha (M) Magnetic Implant | Medtronic Xomed, Inc. | 6 |
| contact forte Alpha | BHM-Tech Produktionsgesellschaft m.b.H. | 5 |
| contact forte | BHM-Tech Produktionsgesellschaft m.b.H. | 5 |
Showing 12 of 230. All products under Hearing Aid, Bone Conduction
Recalls Naming This Product
5 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Sonitus Medical, Inc. | 510(k) number | 2012-02-02 | Not classified | Nonconforming Material/Component | Sonitas received reports of stress cracking on the SoundBite Microphone Tube. | 676 microphones, all sizes. | 2012-03-23 |
| Sonitus Medical, Inc. | 510(k) number | 2012-02-02 | Not classified | Nonconforming Material/Component | Sonitas received reports of stress cracking on the SoundBite Microphone Tube. | 676 microphones, all sizes. | 2012-03-23 |
| Sonitus Medical, Inc. | 510(k) number | 2012-02-02 | Not classified | Nonconforming Material/Component | Sonitas received reports of stress cracking on the SoundBite Microphone Tube. | 676 microphones, all sizes. | 2012-03-23 |
| Sonitus Medical, Inc. | 510(k) number | 2012-02-02 | Not classified | Nonconforming Material/Component | Sonitas received reports of stress cracking on the SoundBite Microphone Tube. | 676 microphones, all sizes. | 2012-03-23 |
| Sonitus Medical, Inc. | 510(k) number | 2012-02-02 | Not classified | Nonconforming Material/Component | Sonitas received reports of stress cracking on the SoundBite Microphone Tube. | 676 microphones, all sizes. | 2012-03-23 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.