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contact forte Alpha

by Bhm-Tech Produktionsgesellschaft Mbh 5 variants

contact forte Alpha (77735913), 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 09120041059742); the registry lists it as not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K243041

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number09120041059742 UDI-DI Date17 Feb 2026ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK243041 Date25 Apr 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K243041 decided 25 Apr 2025 Active
  • FDA GUDID UDI-DI 09120041059742 listed 17 Feb 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K243041
  2. Listed FDA GUDID 09120041059742

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
contact
Generic name
Bone-conduction hearing aid, head-worn
Model / Ref / Catalog
contact forte Alpha, 77735913
Primary DI / UDI-DI
09120041059742
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

Related devices

Cleared under the same submission (K243041)

and 6 more cleared under K243041

Similar devices

Other devices filed under FDA product code LXB (Hearing Aid, Bone Conduction).

Other devices from Bhm-Tech Produktionsgesellschaft Mbh

See all devices from Bhm-Tech Produktionsgesellschaft Mbh →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)