K132278 is an FDA 510(k) clearance for the COCHLEAR BAHA 4 SOUND PROCESSOR. This device is classified as a Hearing Aid, Bone Conduction (Class II - Special Controls, product code LXB).
Submitted by Cochlear Americas (Centennial, US). The FDA issued a Cleared decision on September 26, 2013, 65 days after receiving the submission on July 23, 2013.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3302.
| 510(k) Number | K132278 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 2013 |
| Decision Date | September 26, 2013 |
| Days to Decision | 65 days |
| Submission Type | Special |
| 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 |