| Device Type ID | 1449 |
| Device Name | Hearing Aid, Air Conduction |
| 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) Exempt |
| CFR Regulation Number | 874.3300 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | ESD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1449 |
| Device | Hearing Aid, Air Conduction |
| Product Code | ESD |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Hearing Aid. |
| CFR Regulation Number | 874.3300 [🔎] |
| Device Problems | |
|---|---|
Patient Device Interaction Problem | 2 |
Use Of Device Problem | 2 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Patient-Device Incompatibility | 1 |
Off-Label Use | 1 |
Detachment Of Device Component | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Mechanical Problem | 1 |
Detachment Of Device Or Device Component | 1 |
| Total Device Problems | 11 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Widex A/S | II | Oct-10-2018 |