| Device Type ID | 1653 |
| Device Name | Aids, Speech Training For The Hearing Impaired (ac-powered And Patient-contact) |
| 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 | Enforcement Discretion |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | LEZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1653 |
| Device | Aids, Speech Training For The Hearing Impaired (ac-powered And Patient-contact) |
| Product Code | LEZ |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Siemens Hearing Instruments, Inc | II | Feb-18-2014 |