K200504 is an FDA 510(k) clearance for the BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote. 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 Cleared decision on July 29, 2020, 149 days after receiving the submission on March 2, 2020.
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 | K200504 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 2020 |
| Decision Date | July 29, 2020 |
| Days to Decision | 149 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| 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. |