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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Ear Diseases; Hearing Loss; Hearing Disorders; Otolaryngological Disease
• Intervention / Treatment: Device: Pinna-located microphone; Device: Pinna-simulated microphone algorithm

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Valencia, California, United States, 91355
      • Advanced Bionics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Microphone Location versus Microphone Algorithm Comparison; Comparing performance and subjective feedback for pinna-located microphone versus a pinna-simulated microphone algorithm.	Device: Pinna-located microphone; Sound processors using a pinna-located microphone; Device: Pinna-simulated microphone algorithm; Sound processors using a pinna-simulated algorithm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	8 weeks

Collaborators and Investigators

• Sponsor: Advanced Bionics

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2023
• Primary Completion (Estimated): April 17, 2028
• Study Completion (Estimated): April 17, 2028

Study Registration Dates

• First Submitted: May 5, 2023
• First Submitted That Met QC Criteria: May 5, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Actual): May 13, 2025
• Last Update Submitted That Met QC Criteria: May 8, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Sensation Disorders; Ear Diseases; Hearing Loss; Hearing Disorders; Otorhinolaryngologic Diseases
• Other Study ID Numbers: CPR2301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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