Back to resultsBaseline Performance and Fitting Parameters for Sonova Products
Primary Purpose
Hearing Loss, Ear Diseases, Hearing Disorders
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pinna-located microphone
Pinna-simulated microphone algorithm
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss
Eligibility Criteria
Inclusion Criteria: Ability to provide Informed Consent/Assent Adults (age +18 years) and children (8-17 years) can be enrolled in this study If child is aged 8-17 years, an assent will be completed, and the subject must be accompanied by a parent or legal guardian for all study activities Have the functional capability to operate the controls for the device and to comply with all directions during the study as determined by the investigator conducting the consent/baseline visit English language proficiency as determined by the investigator Exclusion Criteria: • Have any significant medical condition that, in the opinion of any of the investigators, is likely to interfere with study procedures or likely to confound evaluation of study endpoints
Sites / Locations
- Advanced Bionics
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Microphone Location versus Microphone Algorithm Comparison
Arm Description
Comparing performance and subjective feedback for pinna-located microphone versus a pinna-simulated microphone algorithm.
Outcomes
Primary Outcome Measures
Speech performance in noise
The primary efficacy endpoint is recorded AzBio sentences presented from a single loud speaker at 60 dBA. The recognition scores using the pinna-located microphone in quiet and noise captured at initial visit will be compared to the AzBio sentence recognition scores using the pinna-simulated microphone. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
Secondary Outcome Measures
Localization performance
A secondary efficacy endpoint is a front/back localization task where filtered pink noise is presented at 60dBA from one of six speakers in a 360 degree array. Scores are generated in percent correct; the scores obtained from the pinna-located microphone will be compared to the localization scores using the pinna-simulated microphone.
Analysis of usability and preference questionnaire
Subject responses captured on a usability and preference questionnaire at the initial visit will be compared to responses on the questionnaire administered after each two-week chronic use interval. Questions will inquire about subject's ability and experience hearing and listening in different situations and wearing configuration preferences. The questions are rated on a 5-point Likert scale with varying strength, such as "It was easy to verify proper microphone function" with answers ranging from strongly disagree to strongly agree.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05859568
Brief Title
Baseline Performance and Fitting Parameters for Sonova Products
Official Title
Baseline Performance and Fitting Parameters for Sonova Products
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 17, 2023 (Actual)
Primary Completion Date
April 17, 2028 (Anticipated)
Study Completion Date
April 17, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Advanced Bionics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the effectiveness and optimization of various FDA approved products.
Detailed Description
This study uses a prospective within-subjects repeated-measures design in which each subject serves as her/his own control. The purpose of this study is to assess the effectiveness and optimization of various FDA approved hardware, signal preprocessing and processing software, fitting characteristics, and service delivery methods, such as remote support and/or tele-audiology on an expanded subject demographic. The insights gained from this study will be used to optimize listening configuration recommendations, refine audiological practice, and inform future innovations.
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
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Microphone Location versus Microphone Algorithm Comparison
Arm Type
Experimental
Arm Description
Comparing performance and subjective feedback for pinna-located microphone versus a pinna-simulated microphone algorithm.
Intervention Type
Device
Intervention Name(s)
Pinna-located microphone
Intervention Description
Sound processors using a pinna-located microphone
Intervention Type
Device
Intervention Name(s)
Pinna-simulated microphone algorithm
Intervention Description
Sound processors using a pinna-simulated algorithm
Primary Outcome Measure Information:
Title
Speech performance in noise
Description
The primary efficacy endpoint is recorded AzBio sentences presented from a single loud speaker at 60 dBA. The recognition scores using the pinna-located microphone in quiet and noise captured at initial visit will be compared to the AzBio sentence recognition scores using the pinna-simulated microphone. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Localization performance
Description
A secondary efficacy endpoint is a front/back localization task where filtered pink noise is presented at 60dBA from one of six speakers in a 360 degree array. Scores are generated in percent correct; the scores obtained from the pinna-located microphone will be compared to the localization scores using the pinna-simulated microphone.
Time Frame
1 day
Title
Analysis of usability and preference questionnaire
Description
Subject responses captured on a usability and preference questionnaire at the initial visit will be compared to responses on the questionnaire administered after each two-week chronic use interval. Questions will inquire about subject's ability and experience hearing and listening in different situations and wearing configuration preferences. The questions are rated on a 5-point Likert scale with varying strength, such as "It was easy to verify proper microphone function" with answers ranging from strongly disagree to strongly agree.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ability to provide Informed Consent/Assent
Adults (age +18 years) and children (8-17 years) can be enrolled in this study
If child is aged 8-17 years, an assent will be completed, and the subject must be accompanied by a parent or legal guardian for all study activities
Have the functional capability to operate the controls for the device and to comply with all directions during the study as determined by the investigator conducting the consent/baseline visit
English language proficiency as determined by the investigator
Exclusion Criteria:
• Have any significant medical condition that, in the opinion of any of the investigators, is likely to interfere with study procedures or likely to confound evaluation of study endpoints
Facility Information:
Facility Name
Advanced Bionics
City
Valencia
State/Province
California
ZIP/Postal Code
91355
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Baseline Performance and Fitting Parameters for Sonova Products
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