|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) S-SERIES TM SPEECH PROCESSOR|
||Ear Nose & Throat
|Supplement Type||normal 180 day track|
|Supplement Reason|| other report|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for postmarket language study. A postapproval languate study consisting of 20 to 30 children under age 6 will be undertaken using the reynell development language scales revised (rdls). Data will be collected for 3 years at 6-month intervals. The data analysis will include a statistical analysis of effectiveness data -- both the subset of speech intelligibility measures used during the postapproval study as described in amendment#11, dated june 20, 1997, and the reynell test of expressive and receptive ability. Results of the long-term data must be reflected in the labeling, via a pma supplement, when the postapproval study is completed.