Cleared Traditional

contact forte Alpha

K243041 · Bhm-Tech Produktionsgesellschaft Mbh · Ear, Nose, Throat

Apr 2025

Decision

210d

Days

Class 2

Risk

About This 510(k) Submission

K243041 is an FDA 510(k) clearance for the contact forte Alpha, 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 review panel. Regulated under 21 CFR 874.3302.

Submission Details

510(k) Number	K243041 FDA.gov
FDA Decision	Cleared 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