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

NCT ID: NCT05034731

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-18
• Study Completion Date: 2022-05-23

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.

Conditions

Hearing Loss; Ear Diseases; Hearing Disorders; Otolaryngological Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Electric Only

Group Type: OTHER

Remote Fitting

Intervention Type: DEVICE

Processors will be programmed using remote fitting application.

In-Office Fitting

Intervention Type: DEVICE

Processors will be programmed using standard Target CI application.

Aidable Residual Hearing

Group Type: OTHER

Remote Fitting

Intervention Type: DEVICE

Processors will be programmed using remote fitting application.

In-Office Fitting

Intervention Type: DEVICE

Processors will be programmed using standard Target CI application.

Interventions

Remote Fitting

Processors will be programmed using remote fitting application.

Intervention Type: DEVICE

In-Office Fitting

Processors will be programmed using standard Target CI application.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Ability to provide Informed Consent/Assent
• 13 years of age or older
• Unilateral or bilateral user of a HiResolutionTM Bionic Ear System (HiRes 90KTM, HiRes 90KTM Advantage, HiResTM Ultra, HiResTM Ultra 3D)
• Minimum of 6 months of CI experience with a minimum of 1 month experience with a Naída CI or Sky CI sound processor
• At least moderate open-set speech recognition abilities (defined as speech in quiet score ≥ 60% as assessed at Visit 1)
• Minimum average score ≥ 3 on the Mobile Device Proficiency Questionnaire (MDPQ-16)
• English language proficiency as determined by the Investigator
• Willingness to use a BTE sound processor for the duration of the study

• Residual low frequency hearing sensitivity (pure tone average of < 70 dB HL for 125, 250, and 500 Hz) and a severe-to-profound high-frequency sensorineural hearing loss (pure tone average of ≥ 70 dB HL for 1,000, 2,000, 3000, 4,000, and 8,000 Hz) in the implanted ear for unilaterally implanted subjects and in both ears for bilaterally implanted subjects
• Willingness to use an in-canal acoustic earhook for the duration of the study

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

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Advanced Bionics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR0121

Identifier Type: -

Identifier Source: org_study_id