Prospective Randomized Clinical Trial of Advanced Cochlear Implants: Preliminary Results of a Department of Veterans Affairs Cooperative Study

Abstract

This study is a randomized clinical trial to compare the efficacy and safety of one single-channel implant (the 3M/Vienna intracochlear device) and two multichannel cochlear implants (the Nucleus 22-channel device and the Smith & Nephew Richards Ineraid device). Seven Veterans Administration centers are participating in the study. The patient population consists of 82 veterans with postlingual, bilateral profound sensorineural hearing losses who obtain no benefit from amplification. All potential subjects were screened with a battery of audiologic tests. The three device groups are balanced on baseline patient characteristics. One month after operation, the devices were stimulated and programmed and the patients evaluated. Follow-up evaluations were completed at 3 and 12 months poststimulation and then annually until the end of the study. The 12-month data indicate that performance with the multichannel devices is superior to that with the single-channel device.