Baseline Performance and Fitting Parameters for Sonova Products

Hearing Loss Clinical Trial

Official title:

Baseline Performance and Fitting Parameters for Sonova Products

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05859568
• Other study ID #: CPR2301
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 17, 2023
• Est. completion date: April 17, 2028

Study information

• Verified date: March 2024
• Source: Advanced Bionics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: April 17, 2028
• Est. primary completion date: April 17, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ear Diseases
• Hearing Disorders
• Hearing Loss
• Otolaryngological Disease
• Otorhinolaryngologic Diseases

Intervention

Device:
• Pinna-located microphone
Sound processors using a pinna-located microphone
• Pinna-simulated microphone algorithm
Sound processors using a pinna-simulated algorithm

Locations

Country	Name	City	State
United States	Advanced Bionics	Valencia	California

Sponsors (1)

Lead Sponsor	Collaborator
Advanced Bionics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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