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Evaluation of Remote Fitting in Adult and Pediatric Users of the HiResolution Bionic Ear System

Hearing Loss Clinical Trial

Official title:
Evaluation of Remote Fitting in Adult and Pediatric Users of the HiResolution Bionic Ear System

Clinical Trial Summary

This is a prospective within-subjects repeated-measures study that will enroll 17 users 13 years or older implanted with a HiResolution Bionic Ear System.

Clinical Trial Description

The overall goal of this clinical study is to demonstrate the safety and efficacy of the remote fitting option. Hearing outcomes are expected to be similar whether a study subject's sound processor is programmed in the traditional method in the audiologist's office or whether programming is performed via remote fitting. Therefore, the study described herein uses a non-inferiority design to determine whether sentence recognition in quiet is no worse with remote fitting than in an in-office setting. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05034731
Study type Interventional
Source Advanced Bionics
Contact
Status Completed
Phase
Start date August 18, 2021
Completion date May 23, 2022
View Details
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