K191921 is an FDA 510(k) clearance for the Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments. This device is classified as a Active Implantable Bone Conduction Hearing System (Class II - Special Controls, product code PFO).
Submitted by Cochlear Americas (Centennial, US). The FDA issued a Cleared decision on November 15, 2019, 120 days after receiving the submission on July 18, 2019.
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 | K191921 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 2019 |
| Decision Date | November 15, 2019 |
| Days to Decision | 120 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. |