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Enrolling by Invitation

NCT Number: NCT05859568

Baseline Performance and Fitting Parameters for Sonova Products

The purpose of this study is to assess the effectiveness and optimization of various FDA approved products.

Enrolling by Invitation

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otolaryngological Disease Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Advanced Bionics

Valencia, California, 91355, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pinna-located microphone

Device

Sound processors using a pinna-located microphone

Pinna-simulated microphone algorithm

Device

Sound processors using a pinna-simulated algorithm

Primary outcomes

  1. Speech performance in noise

    Time frame: 1 day

    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 outcomes

  1. Localization performance

    Time frame: 1 day

    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.

  2. Analysis of usability and preference questionnaire

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Advanced Bionics

Industry

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
May 16, 2023
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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