Baseline Performance and Fitting Parameters for Sonova Products
1 other identifier
interventional
20
1 country
1
Brief Summary
The purpose of this study is to assess the effectiveness and optimization of various FDA approved products.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 17, 2023
CompletedFirst Submitted
Initial submission to the registry
May 5, 2023
CompletedFirst Posted
Study publicly available on registry
May 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 17, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 17, 2028
May 13, 2025
May 1, 2025
5 years
May 5, 2023
May 8, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
1 day
Secondary Outcomes (2)
Localization performance
1 day
Analysis of usability and preference questionnaire
8 weeks
Study Arms (1)
Microphone Location versus Microphone Algorithm Comparison
EXPERIMENTALComparing performance and subjective feedback for pinna-located microphone versus a pinna-simulated microphone algorithm.
Interventions
Sound processors using a pinna-located microphone
Sound processors using a pinna-simulated algorithm
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Advanced Bionicslead
Study Sites (1)
Advanced Bionics
Valencia, California, 91355, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2023
First Posted
May 16, 2023
Study Start
April 17, 2023
Primary Completion (Estimated)
April 17, 2028
Study Completion (Estimated)
April 17, 2028
Last Updated
May 13, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share