Contact Forte Alpha
by Bhm-Tech Produktionsgesellschaft Mbh
510(k) K243041
Active
Valid until
No date given
FDA recalls
None found
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK243041 | Date25 Apr 2025 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Official records
Across registries
- FDA 510(k) K243041 decided 25 Apr 2025 Active
- EUDAMED Active
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA product code
- LXB
- Device class
- Class II
- Regulation
- 21 CFR Part 874.3302
- Advisory committee
- Ear, Nose, Throat
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Contact Forte Alpha is a bone conduction hearing aid designed to compensate for mild to moderate hearing impairment. It processes and amplifies sound before transmitting vibrations directly to the inner ear via bone conduction technology, bypassing the outer and middle ear.
This device is supplied as a reusable, digital hearing system with wireless connectivity, including Bluetooth compatibility. It is classified as a Class II medical device under FDA regulations and the Medical Devices Directive (MDD), with an FDA 510(k) clearance (K243041) and product code LXB. No sterility or single-use specifications are indicated.
Devices cleared under K243041
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| contact forte | 77735897 / contact forte | 09120041059582 | — | No longer on the market |
| contact forte | 77735898 / contact forte | 09120041059599 | — | No longer on the market |
| contact forte | 77735899 / contact forte | 09120041059605 | — | No longer on the market |
| contact forte | 77735900 / contact forte | 09120041059612 | — | No longer on the market |
| contact forte | 77735904 / contact forte | 09120041059650 | — | No longer on the market |
| contact forte | 77735905 / contact forte | 09120041059667 | — | No longer on the market |
| contact forte | 77735906 / contact forte | 09120041059674 | — | No longer on the market |
| contact forte | 77735907 / contact forte | 09120041059681 | — | No longer on the market |
| contact forte | 77735908 / contact forte | 09120041059698 | — | No longer on the market |
| contact forte | 77735916 / contact forte | 09120041059575 | — | No longer on the market |
| contact forte Alpha | 77735909 / contact forte Alpha | 09120041059704 | — | No longer on the market |
| contact forte Alpha | 77735910 / contact forte Alpha | 09120041059711 | — | No longer on the market |
| contact forte Alpha | 77735911 / contact forte Alpha | 09120041059728 | — | No longer on the market |
| contact forte Alpha | 77735912 / contact forte Alpha | 09120041059735 | — | No longer on the market |
| contact forte Alpha | 77735913 / contact forte Alpha | 09120041059742 | — | No longer on the market |
| contact forte Alpha BB/USA | 77735941 / BB/USA | 09120041056697 | — | On the market |
| contact forte Alpha BL/USA | 77735943 / BL/USA | 09120041056703 | — | On the market |
| contact forte Alpha BP/USA | 77735945 / BP/USA | 09120041056673 | — | On the market |
| contact forte Alpha RT/USA | 77735947 / RT/USA | 09120041056710 | — | On the market |
| contact forte Alpha SW/USA | 77735949 / SW/USA | 09120041056727 | — | On the market |
| contact forte BB/USA | 77736125 / BB/USA | 09120041056734 | — | On the market |
| contact forte BL/USA | 77736126 / BL/USA | 09120041056741 | — | On the market |
| contact forte BP/USA | 77736127 / BP/USA | 09120041056758 | — | On the market |
| contact forte RT/USA | 77736128 / RT/USA | 09120041056765 | — | On the market |
| contact forte SW/USA | 77736129 / SW/USA | 09120041056772 | — | On the market |
| Hearbow contact forte/SW | 77736097 / contact forte/SW | 09120041056895 | — | On the market |
Similar devices
Other devices filed under FDA product code LXB (Hearing Aid, Bone Conduction).
- BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II by Entific Medical Systems, Inc.
- Baha 5 Power Sound Processor by Cochlear Americas
- XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL by Xomed, Inc.
- BAHA 3 POWER SOUND PROCESSOR by Cochlear Americas
- OTOMAG BONE CONDUCTION HEARING SYSTEM by Sophono, Inc.
- Bone conduction Hearing Aid (BM100) by Shokz Health Global Limited
- Ponto 3, Ponto 3 Power and Ponto 3 SuperPower by Oticon Medical AB
- Baha 93363 by Cochlear Bone Anchored Solutions AB
- Bone Conduction Hearing Aid (XTS-AISW-D1) by SHENZEN MAGNET TECHNOLOGY CO.,LTD
- Baha 92141 by Cochlear Bone Anchored Solutions AB