K243041 is an FDA 510(k) clearance for the contact forte Alpha. This device is classified as a Hearing Aid, Bone Conduction (Class II - Special Controls, product code LXB).
Submitted by Bhm-Tech Produktionsgesellschaft Mbh (Grafenschachen, AT). The FDA issued a Cleared decision on April 25, 2025, 210 days after receiving the submission on September 27, 2024.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3302.
| 510(k) Number | K243041 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2024 |
| Decision Date | April 25, 2025 |
| Days to Decision | 210 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | LXB - Hearing Aid, Bone Conduction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3302 |