K082108 is an FDA 510(k) clearance for the OBC BONE ANCHORED HEARING AID SYSTEM. This device is classified as a Hearing Aid, Bone Conduction (Class II - Special Controls, product code LXB).
Submitted by Oticon Medical AB (Gothenburg, Askim, SE). The FDA issued a Cleared decision on November 14, 2008, 112 days after receiving the submission on July 25, 2008.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3302.
| 510(k) Number | K082108 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 2008 |
| Decision Date | November 14, 2008 |
| Days to Decision | 112 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 |