Definition: Intended To Provide Electric Stimulation To The Mid To High Frequency Region Of The Cochlea And Acoustic Amplification To The Low Frequency Regions, For Patients With Residual Low Frequency Hearing Sensitivity.
| Device Type ID | 1668 |
| Device Name | Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification |
| Physical State | External Sound Processor, Implant (w/ Receiver/stimulator And Electrode Array), Programming Software, Accessories |
| Technical Method | Provide Electric Stimulation To The Mid- To High Frequency Region Of The Cochlea Via Implant And Acoustic Amplification To The Low Frequency Regions Via An External Component |
| Target Area | Head: Ear And Cochlea |
| Review Panel | Ear Nose & Throat |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Ear, Nose, And Throat Devices Branch (ENTB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PGQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1668 |
| Device | Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification |
| Product Code | PGQ |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Appropriate Term/Code Not Available | 63 |
Extrusion | 2 |
Migration Or Expulsion Of Device | 2 |
Insufficient Information | 2 |
Magnet | 1 |
Receiver Stimulator Unit | 1 |
Electrode | 1 |
| Total Device Problems | 72 |