DEN170009 is an FDA 510(k) submission for the Bonebridge. This device is classified as a Active Implantable Bone Conduction Hearing System (Class II - Special Controls, product code PFO).
Submitted by Med-El Elektromedizinische Geraete GmbH (Innsbruck, AT). The FDA issued a Not Cleared (DENG) decision on July 20, 2018.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3340. An Active Implantable Bone Conduction Hearing System Is A Prescription Device Consisting Of An Implanted Transducer, Implanted Electronics Components, And An Audio Processor. The Active Implantable Bone Conduction Hearing System Is Intended To Compensate For Conductive Or Mixed Hearing Losses By Conveying Amplified Acoustic Signals To The Cochlea Via Mechanical Vibrations On The Skull Bone..
| 510(k) Number | DEN170009 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | February 13, 2017 |
| Decision Date | July 20, 2018 |
| Days to Decision | 522 days |
| Submission Type | Direct |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | - |
| Product Code | PFO - Active Implantable Bone Conduction Hearing System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3340 |
| Definition | An Active Implantable Bone Conduction Hearing System Is A Prescription Device Consisting Of An Implanted Transducer, Implanted Electronics Components, And An Audio Processor. The Active Implantable Bone Conduction Hearing System Is Intended To Compensate For Conductive Or Mixed Hearing Losses By Conveying Amplified Acoustic Signals To The Cochlea Via Mechanical Vibrations On The Skull Bone. |