K152067 is an FDA 510(k) clearance for the Ponto bone anchored hearing system. This device is classified as a Hearing Aid, Bone Conduction, Implanted (Class II - Special Controls, product code MAH).
Submitted by Oticon Medical AB (Askim, SE). The FDA issued a Cleared decision on November 23, 2015, 122 days after receiving the submission on July 24, 2015.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3302.
| 510(k) Number | K152067 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 2015 |
| Decision Date | November 23, 2015 |
| Days to Decision | 122 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | MAH — Hearing Aid, Bone Conduction, Implanted |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3302 |