Adhear User Kit, Simply Black/beige
2 catalogue numbers from 35941, listed by Med-El Elektromedizinische Geräte Gesellschaft m.b.H., under Hearing Aid, Bone Conduction. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
2catalogue 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 | Med-El Elektromedizinische Geräte Gesellschaft m.b.H. |
|---|---|
| FDA product code | LXB |
| Device type | Hearing Aid, Bone Conduction |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3302 |
| 510(k) | K172460 |
| Record published | 2018-06-27 |
| Record revised | 2024-02-22 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | expiry date, serial number |
| Storage | Special storage condition: Store the Adhesive Adapters in a dry place at room temperature.; Storage environment humidity 40 to 60 % RH; Storage environment temperature 50 to 80 °F; Storage environment temperature 10 to 27 °C |
| Distribution end date | 2024-01-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 35941 | Withdrawn | |
| 34731 | Withdrawn |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 |
| 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
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.