K240614 is an FDA 510(k) clearance for the Sentio Ti Implant Kit. This device is classified as a Active Implantable Bone Conduction Hearing System (Class II - Special Controls, product code PFO).
Submitted by Oticon Medical AB (Askim, SE). The FDA issued a Cleared decision on July 10, 2024, 127 days after receiving the submission on March 5, 2024.
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 | K240614 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 2024 |
| Decision Date | July 10, 2024 |
| Days to Decision | 127 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. |