Clinical Evaluation of a Cochlear Implant Sound Processor

Status Completed

Clinical Trial Summary

This is a prospective within-subjects repeated-measures study that will enroll 24 adult users implanted with a HiResolution Bionic Ear System (HiRes 90K or newer). Subjects will be assigned to one of two cohorts based on audiometric results at the Baseline visit

Clinical Trial Description

The overall goal of this clinical study is to demonstrate the safety and efficacy of a cochlear implant sound processor. Hearing outcomes are expected to be similar non-inferior to as compared to the currently approved software and processors. Therefore, the study described herein uses a non-inferiority design to determine whether sentence recognition in quiet and in noise is no worse with the new sound processor than with currently approved software on a Q90 processor. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04237207
Study type	Interventional
Source	Advanced Bionics
Contact
Status	Completed
Phase	N/A
Start date	December 17, 2019
Completion date	October 15, 2020

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