contact forte Alpha
by Bhm-Tech Produktionsgesellschaft Mbh 5 variants
contact forte Alpha (77735909), a bone-conduction hearing aid (FDA Class II; FDA product code LXB, Hearing Aid, Bone Conduction) made by Bhm-Tech Produktionsgesellschaft Mbh, was cleared under FDA 510(k) K243041 on 25 Apr 2025 and listed in FDA GUDID on 17 Feb 2026 (UDI-DI 09120041059704); the registry lists it as not in commercial distribution (GUDID) as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number09120041059704 | Date17 Feb 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK243041 | Date25 Apr 2025 | StatusActive |
Official records
- AccessGUDID record 09120041059704
- FDA 510(k) database K243041
Across registries
- FDA 510(k) K243041 decided 25 Apr 2025 Active
- FDA GUDID UDI-DI 09120041059704 listed 17 Feb 2026 Listed
Timeline
- Cleared FDA 510(k) K243041
- Listed FDA GUDID 09120041059704
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- contact
- Generic name
- Bone-conduction hearing aid, head-worn
- Model / Ref / Catalog
- contact forte Alpha, 77735909
- Primary DI / UDI-DI
- 09120041059704
- 510(k) Number
- FDA product code
- LXB
- GMDN term
- Bone-conduction hearing aid, head-worn
- Device class
- Class II
- Regulation number
- 874.3302
- GUDID distribution status
- Not in Commercial Distribution
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