K172460 is an FDA 510(k) clearance for the ADHEAR System. This device is classified as a Hearing Aid, Bone Conduction (Class II - Special Controls, product code LXB).
Submitted by Med-El Elektromedizinische Geraete GmbH (Innsbruck, AT). The FDA issued a Cleared decision on April 27, 2018, 256 days after receiving the submission on August 14, 2017.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3302.
| 510(k) Number | K172460 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 14, 2017 |
| Decision Date | April 27, 2018 |
| Days to Decision | 256 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 |