K161123 is an FDA 510(k) clearance for the Baha 5 Power 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 May 20, 2016, 29 days after receiving the submission on April 21, 2016.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3302.
| 510(k) Number | K161123 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 21, 2016 |
| Decision Date | May 20, 2016 |
| Days to Decision | 29 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 |