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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hearing Aid, Bone Conduction
510(k) Number K243041
Device Name contact forte Alpha
Applicant
Bhm-Tech Produktionsgesellschaft Mbh
Grafenschachen 242
Grafenschachen,  AT 7423
Applicant Contact Markus Hirtzi
Correspondent
Bhm-Tech Produktionsgesellschaft Mbh
Grafenschachen 242
Grafenschachen,  AT 7423
Correspondent Contact Markus Hirtzi
Regulation Number874.3302
Classification Product Code
LXB  
Date Received09/27/2024
Decision Date 04/25/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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