| Device Type ID | 1596 |
| Device Name | Kit, Earmold, Impression |
| 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 | LDG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1596 |
| Device | Kit, Earmold, Impression |
| Product Code | LDG |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Hearing Aid. |
| CFR Regulation Number | 874.3300 [🔎] |
| Device Problems | |
|---|---|
Human-Device Interface Problem | 2 |
Use Of Device Problem | 1 |
| Total Device Problems | 3 |