An interventional study of Pinna-located microphone and Pinna-simulated microphone algorithm in Hearing Loss, Ear Diseases and Hearing Disorders, sponsored by Advanced Bionics. Enrolling by invitation at 1 site in United States. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2025-05-13.
Sponsored by Advanced Bionics (part of Sonova AG) · Not applicable, Interventional, and Treatment
The purpose of this study is to assess the effectiveness and optimization of various FDA approved products.
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.
796 studies on the registry are indexed under Hearing Loss; 193 are open to participants now.
This study's planned enrollment of 20 is below the median of 44 across 561 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →Advanced Bionics is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
First submitted after Advanced Bionics AG became part of Sonova AG.
Counted across the registry records on this site, refreshed daily.
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Adults (age +18 years) and children (8-17 years) can be enrolled in this study
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Comparing performance and subjective feedback for pinna-located microphone versus a pinna-simulated microphone algorithm.
Device: Pinna-located microphone · Device: Pinna-simulated microphone algorithm
Sound processors using a pinna-located microphone
Sound processors using a pinna-simulated algorithm
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.
Time frame: 1 day
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.
Time frame: 1 day
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.
Time frame: 8 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2023 (actual). Primary completion is estimated for Apr 2028, 60 months after the start.
Of 125 industry-sponsored interventional studies with no phase under Hearing Loss, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 15. This study's planned 60 months is above that.
Counting every sponsor, half of 321 studies reached it within 19 months; a quarter within 5 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
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