Issues in protocol design for cochlear implant clinical trials in children: the Clarion Pediatric Study.
Clinical trials of the Clarion multichannel cochlear implant in postlingually deaf adults have been ongoing since 1991, and clinical investigation of the device in children is projected to begin in the first quarter of 1995. The purpose of this paper is to present some of the issues encountered in developing research protocols for clinical trials of cochlear implants in the pediatric population, with special reference to the protocol that will be employed in the Clarion pediatric investigation.
Osberger
M J
MJ
Advanced Bionics Corporation, Sylmar, California, USA.
Kessler
D
D
D002648:Child; D002986:Clinical Trials as Topic / Q000379:methods*; D003054:Cochlear Implants; D006801:Humans