Hearing Aid, Bone Conduction
Scale S0390 Magnetic Retention W/Weight
4manufacturers in China registered for this device type
21catalogue 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 | Medtronic Xomed, Inc., United States |
|---|---|
| FDA product code | LXB |
| Device type | Hearing Aid, Bone Conduction |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3302 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K100193 |
| Record published | 2016-04-15 |
| Record revised | 2026-07-03 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2024-11-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S0390 | Withdrawn | |
| S0264-21 | Withdrawn | |
| S0585-00 | Withdrawn | |
| S0585-00 | Withdrawn | |
| S0278-00 | Withdrawn | |
| S0265-00 | Withdrawn | |
| S0268-00 | Withdrawn | |
| S0264-31 | Withdrawn | |
| S0264-11 | Withdrawn | |
| S0394 | Withdrawn | |
| S0264-22 | Withdrawn | |
| S0390 | Withdrawn | |
| S0278-00 | Withdrawn | |
| S0278-00 | Withdrawn | |
| S0264-42 | Withdrawn | |
| S0264-32 | Withdrawn | |
| S0264-41 | Withdrawn | |
| S0278-00 | Withdrawn | |
| S0394 | Withdrawn | |
| S0264-12 | Withdrawn | |
| S0268-00 | Withdrawn |
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 |
| 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 |
| 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.