K142678 is an FDA 510(k) clearance for the Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm. 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 January 21, 2015, 124 days after receiving the submission on September 19, 2014.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3302.
| 510(k) Number | K142678 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 2014 |
| Decision Date | January 21, 2015 |
| Days to Decision | 124 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 |