| Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device. |
| |
| Trade Name | NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM |
|---|
| Generic Name | auditory brainstem implant |
|---|
| Applicant | COCHLEAR AMERICAS |
|---|
| PMA Number | P000015 |
|---|
| Date Received | 03/29/2000 |
|---|
| Decision Date | 10/20/2000 |
|---|
| Product Code | |
| Docket Number | 00M-1659 |
|---|
| Notice Date | 12/12/2000 |
|---|
| Advisory Committee |
Ear Nose & Throat |
|---|
| Expedited Review Granted? | Yes |
|---|
| Combination Product |
No
|
|---|
| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
|---|
Approval Order Statement
Approval for the nucleus 24 auditory brainstem implant (abi) system, which is intended to restore useful hearing via electrical stimulation of the cochlear nucleus. The device is indicated for individuals 12 years of age or older, who have been diagnosed with neurofibromatosis type 2 (nf2). Implantation may occur during first or second-side tumor removal, or in patients with previously removed acoustic tumors bilaterally. Because the surgical procedure for tumor excision and electrode placement eliminates residual hearing, preoperative audiological criteria are not relevant. Prospective implant recipients and their families should have appropriate expectations, regarding the potential benefits of an auditory brainstem implant and should be highly motivated to participate in the postopearative rehabilitation process. |
| Approval Order |
Approval Order
|
| Supplements: |
S001 S002 S003 S004 S005 S006
S008 S010 S011 |
|
|
