OAF · Implant, Hearing, Active, Middle Ear, Totally Implanted
· Class 3
Overview
| Product Code | OAF |
|---|---|
| Device Name | Implant, Hearing, Active, Middle Ear, Totally Implanted |
| Device Class | Class 3 |
| Review Panel | |
| Implant | Yes |
Identification
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%.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P090018 | ESTEEM TOTALLY IMPLANTABLE HEARING SYSTEM | Envoy Medical Corporation | Mar 17, 2010 | APPR |
Top Applicants
- Envoy Medical Corporation — 1 clearance
