Contact Forte Alpha
bone conduction hearing aid, ALPHA, BB/babyblue
4manufacturers in China registered for this device type
5catalogue numbers in this listing
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 | BHM-Tech Produktionsgesellschaft m.b.H. |
|---|---|
| FDA product code | LXB |
| Device type | Hearing Aid, Bone Conduction |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3302 |
| 510(k) | K243041 |
| Record published | 2026-04-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 10 to 95 % RH; Storage environment temperature -20 to 60 °C |
| Packaging | Cardboard |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BB/USA | In distribution | |
| BL/USA | In distribution | |
| BP/USA | In distribution | |
| SW/USA | In distribution | |
| RT/USA | 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 | BHM-Tech Produktionsgesellschaft m.b.H. | 5 |
| Baha 5 SuperPower Actuator unit | Cochlear Bone Anchored Solutions AB | 4 |
Showing 12 of 230. All products under Hearing Aid, Bone Conduction
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.