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

Completed

• Conditions: Ear Diseases; Hearing Disorders; Hearing Loss; Otolaryngological Disease

• Registration Number: NCT05034731
• Lead Sponsor: Advanced Bionics

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2021-07-28
• Study Start: 2021-08-18
• Study First Submitted QC: 2021-09-01
• Study First Posted: 2021-09-05
• Primary Completion: 2022-05-23
• Study Completion: 2022-05-23
• Results First Submitted: 2023-07-28
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-29
• Last Update Submitted: 2023-08-29
• Results First Posted: 2023-09-21
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Not provided

Exclusion Criteria

• Clinical presentation indicative of potential implanted device malfunction
• Unrealistic expectations regarding potential benefits, risks and limitations of the investigational device as determined by the Investigator
• Unwillingness or inability of subject to comply with all investigational requirements as determined by the Investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Speech Performance in Quiet After Chronic Use (EO Only)	2-3 weeks after fitting	The primary efficacy endpoint is the chronic AzBio sentence recognition scores in quiet captured two-to-three weeks post investigational remote fitting (visit 3) as compared to the chronic AzBio sentence recognition scores in quiet captured two-to-three weeks post control in-office fitting (visit 2). Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
Speech Performance in Quiet - Chronic Use (Includes Overall - Both Groups)	Test performed 2-3 weeks after fitting	The primary efficacy endpoint is the chronic AzBio sentence recognition scores in quiet captured two-to-three weeks post investigational remote fitting (visit 3) as compared to the chronic AzBio sentence recognition scores in quiet captured two-to-three weeks post control in-office fitting (visit 2). Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.

Trial Locations

Locations (1)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States