| Device Type ID | 1662 |
| Device Name | Implant, Hearing, Active, Middle Ear, Partially Implanted |
| 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 | MPV |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1662 |
| Device | Implant, Hearing, Active, Middle Ear, Partially Implanted |
| Product Code | MPV |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 162 |
Adverse Event Without Identified Device Or Use Problem | 55 |
Output Problem | 49 |
No Device Output | 13 |
Insufficient Information | 10 |
Migration | 10 |
Device Appears To Trigger Rejection | 8 |
Device Stops Intermittently | 2 |
Device Inoperable | 2 |
Improper Device Output | 1 |
Escape | 1 |
Migration Or Expulsion Of Device | 1 |
Output Below Specifications | 1 |
Extrusion | 1 |
Device Dislodged Or Dislocated | 1 |
Appropriate Term/Code Not Available | 1 |
Cut In Material | 1 |
No Audible Prompt / Feedback | 1 |
| Total Device Problems | 320 |