| Device Type ID | 1609 |
| Device Name | Hearing Aid, Bone Conduction, Implanted |
| Regulation Description | Hearing Aid. |
| Regulation Medical Specialty | Ear Nose & Throat |
| 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 | 510(k) |
| CFR Regulation Number | 874.3300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MAH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1609 |
| Device | Hearing Aid, Bone Conduction, Implanted |
| Product Code | MAH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hearing Aid. |
| CFR Regulation Number | 874.3300 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
COCHLEAR AMERICAS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
WILLIAM DEMANT HOLDING A/S | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Appropriate Term/Code Not Available | 1018 |
Failure To Osseointegrate | 333 |
Loss Of Osseointegration | 287 |
Insufficient Information | 19 |
Extrusion | 15 |
Device Displays Incorrect Message | 3 |
Patient-Device Incompatibility | 3 |
Osseointegration Problem | 3 |
Explanted | 2 |
Magnet | 2 |
Shelf Life Exceeded | 1 |
Missing Value Reason | 1 |
Malposition Of Device | 1 |
Receiver Stimulator Unit | 1 |
Device Remains Implanted | 1 |
Separation Failure | 1 |
Expulsion | 1 |
Use Of Device Problem | 1 |
No Flow | 1 |
No Apparent Adverse Event | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Battery | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Device Operates Differently Than Expected | 1 |
Device Operational Issue | 1 |
Expiration Date Error | 1 |
Implant Breakage Or Physical Damage | 1 |
| Total Device Problems | 1702 |