Device |
implant, hearing, active, middle ear, totally implanted |
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%. |
Physical State |
All components: microphone, sensor, electronics, audio processor, battery and driver are hermetically sealed inside the housing and implanted. Programming accessories are separate. |
Technical Method |
surgically implanted |
Target Area |
Mastoid bone |
Review Panel |
Ear Nose & Throat |
Product Code | OAF |
Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Division of Dental and ENT Devices
(DHT1B)
|
Submission Type |
PMA
|
Device Class |
3
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|