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

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.

Study Overview

• Status: Completed
• Conditions: Ear Diseases; Hearing Loss; Hearing Disorders; Otolaryngological Disease
• Intervention / Treatment: Device: Remote Fitting; Device: In-Office Fitting

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 Type: Interventional
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria All Subjects

• 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

Inclusion Criteria Specific to Aidable Residual Hearing Group

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Electric Only	Device: Remote Fitting; Processors will be programmed using remote fitting application.; Device: In-Office Fitting; Processors will be programmed using standard Target CI application.
Other: Aidable Residual Hearing	Device: Remote Fitting; Processors will be programmed using remote fitting application.; Device: In-Office Fitting; Processors will be programmed using standard Target CI application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech Performance in Quiet After Chronic Use (EO Only)	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.	2-3 weeks after fitting
Speech Performance in Quiet - Chronic Use (Includes Overall - Both Groups)	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.	Test performed 2-3 weeks after fitting

Collaborators and Investigators

• Sponsor: Advanced Bionics

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2021
• Primary Completion (Actual): May 23, 2022
• Study Completion (Actual): May 23, 2022

Study Registration Dates

• First Submitted: July 28, 2021
• First Submitted That Met QC Criteria: September 1, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Sensation Disorders; Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases
• Other Study ID Numbers: CR0121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO