| 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%. |
| Product Code | OAF |
| Device Class |
3
|
| Premarket Approvals (PMA) |
| 2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
|
0
|
0
|
0
|
7
|
6
|
3
|
2
|
|
| Recalls |
| |
2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
| Class I |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
| Class II |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
| Class III |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
