Back to resultsEvaluation of Remote Fitting in Adult and Pediatric Users of the HiResolution Bionic Ear System
Primary Purpose
Hearing Loss, Ear Diseases, Hearing Disorders
Status
Completed
Phase
Locations
United States
Study Type
Interventional
Intervention
Remote Fitting
In-Office Fitting
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss
Eligibility Criteria
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
Sites / Locations
- University of Colorado Anschutz Medical Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Electric Only
Aidable Residual Hearing
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05034731
Brief Title
Evaluation of Remote Fitting in Adult and Pediatric Users of the HiResolution Bionic Ear System
Official Title
Evaluation of Remote Fitting in Adult and Pediatric Users of the HiResolution Bionic Ear System
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 18, 2021 (Actual)
Primary Completion Date
May 23, 2022 (Actual)
Study Completion Date
May 23, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Advanced Bionics
4. Oversight
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Ear Diseases, Hearing Disorders, Otolaryngological Disease
7. Study Design
Primary Purpose
Treatment
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electric Only
Arm Type
Other
Arm Title
Aidable Residual Hearing
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Remote Fitting
Intervention Description
Processors will be programmed using remote fitting application.
Intervention Type
Device
Intervention Name(s)
In-Office Fitting
Intervention Description
Processors will be programmed using standard Target CI application.
Primary Outcome Measure Information:
Title
Speech Performance in Quiet After Chronic Use (EO Only)
Description
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.
Time Frame
2-3 weeks after fitting
Title
Speech Performance in Quiet - Chronic Use (Includes Overall - Both Groups)
Description
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.
Time Frame
Test performed 2-3 weeks after fitting
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Remote Fitting in Adult and Pediatric Users of the HiResolution Bionic Ear System
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