OAF — Implant, Hearing, Active, Middle Ear, Totally Implanted Class III
FDA product code OAF covers "Implant, Hearing, Active, Middle Ear, Totally Implanted", a Class III medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants.
Classification Details
- Product Code
- OAF
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Unknown
- Implant
- Yes
Definition
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%.