PMA P960058S002

Device: CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) S-SERIES TM SPEECH PROCESSOR
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S002
Decision date: 1998-06-22
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.

Current openFDA PMA Record#

Device: CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) S-SERIES TM SPEECH PROCESSOR
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S002
Decision date: 1998-06-22
Decision code: APPR
Date received: 1997-11-25
Supplement type: Normal 180 Day Track
Supplement reason: Other
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.