Definition: Intended To Provide Useful Hearing To Persons With Sensorineural Hearing Loss. Indicated For Adults With Mild To Severe Sensorineural Hearing Loss Who Have A Speech Discrimination Score Greater Than Or Equal To 60%.
| Device Type ID | 1665 |
| Device Name | Implant, Hearing, Active, Middle Ear, Totally Implanted |
| Physical State | All Components: Microphone, Sensor, Electronics, Audio Processor, Battery And Driver Are Hermetically Sealed Inside The Housing And Implanted. Programming Accessories Are Separate. |
| Technical Method | Surgically Implanted |
| Target Area | Mastoid Bone |
| 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 | OAF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1665 |
| Device | Implant, Hearing, Active, Middle Ear, Totally Implanted |
| Product Code | OAF |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 38 |
Premature Discharge Of Battery | 14 |
Device Inoperable | 14 |
Electrical /Electronic Property Problem | 7 |
Low Impedance | 6 |
Impedance Problem | 5 |
Difficult To Insert | 2 |
Fluid Leak | 2 |
Device Damaged By Another Device | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Improper Device Output | 2 |
Intermittent Continuity | 2 |
Physical Property Issue | 2 |
Header | 1 |
Output Below Specifications | 1 |
Weld | 1 |
Decoupling | 1 |
Low Readings | 1 |
Facilities Issue | 1 |
Device Operational Issue | 1 |
Installation-Related Problem | 1 |
Device Issue | 1 |
Fitting Problem | 1 |
Cut In Material | 1 |
Blocked Connection | 1 |
Device Damaged Prior To Use | 1 |
| Total Device Problems | 111 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Envoy Medical Corporation | II | Aug-01-2018 |