Back to resultsHearing Aid Quality and Reliability Study
Primary Purpose
Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phonak Audeo hearing aid
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss
Eligibility Criteria
Inclusion Criteria:
Adults with mild to moderate severe sensorineural hearing loss
Exclusion Criteria:
-
Sites / Locations
- Sonova
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hearing Aid
Arm Description
Participants will wear Phonak rechargeable Audeo hearing aids
Outcomes
Primary Outcome Measures
Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 1
Test box electroacoustic measurements of hearing aid done at full on settings must meet manufacturer product specifications per manufacturer data sheet. This includes maximum and high frequency average output sound pressure level, maximum and high frequency average acoustic gain, frequency response range, total harmonic distortion and equivalent input noise level. This is done using an Audioscan Verifit2 electroacoustic analyzer.
Electroacoustic measurements listed above will also be taken with hearing aid set to user settings, as a baseline measure for all future appointments.
Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 45
Test box electroacoustic measurements (using the Audioscan Verifit 2 Electroacoustic Analyzer) of hearing aid done at user gain settings after daily use for extended period of time. Results will be compared to baseline electroacoustic measures taken on day 1 of study. A "pass" means that devices were within tolerance levels (per ANSI S3.22-2014) of baseline measures. A "fail" means that devices were not within tolerance levels of one or more baseline measures (i.e. output, gain, frequency range, total harmonic distortion, or equivalent input noise level).
Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 90
Test box electroacoustic measurements of hearing aid done at user gain settings after daily use for extended period of time. Test box electroacoustic measurements of hearing aid done at user gain settings after daily use for extended period of time. Results will be compared to baseline electroacoustic measures taken on day 1 of study. A "pass" means that devices were within tolerance levels (per ANSI S3.22-2014) of baseline measures. A "fail" means that devices were not within tolerance levels of one or more baseline measures (i.e. output, gain, frequency range, total harmonic distortion, or equivalent input noise level).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04995666
Brief Title
Hearing Aid Quality and Reliability Study
Official Title
Hearing Aid Quality Check and Reliability Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 8, 2021 (Actual)
Primary Completion Date
September 13, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonova AG
4. Oversight
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
5. Study Description
Brief Summary
Quality and reliability study of hearing aid. Adults with mild to severe hearing loss will wear hearing aids daily for approximately 3 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hearing Aid
Arm Type
Experimental
Arm Description
Participants will wear Phonak rechargeable Audeo hearing aids
Intervention Type
Device
Intervention Name(s)
Phonak Audeo hearing aid
Intervention Description
Rechargeable hearing aid
Primary Outcome Measure Information:
Title
Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 1
Description
Test box electroacoustic measurements of hearing aid done at full on settings must meet manufacturer product specifications per manufacturer data sheet. This includes maximum and high frequency average output sound pressure level, maximum and high frequency average acoustic gain, frequency response range, total harmonic distortion and equivalent input noise level. This is done using an Audioscan Verifit2 electroacoustic analyzer.
Electroacoustic measurements listed above will also be taken with hearing aid set to user settings, as a baseline measure for all future appointments.
Time Frame
Day 1 of study
Title
Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 45
Description
Test box electroacoustic measurements (using the Audioscan Verifit 2 Electroacoustic Analyzer) of hearing aid done at user gain settings after daily use for extended period of time. Results will be compared to baseline electroacoustic measures taken on day 1 of study. A "pass" means that devices were within tolerance levels (per ANSI S3.22-2014) of baseline measures. A "fail" means that devices were not within tolerance levels of one or more baseline measures (i.e. output, gain, frequency range, total harmonic distortion, or equivalent input noise level).
Time Frame
Day 45 of study
Title
Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 90
Description
Test box electroacoustic measurements of hearing aid done at user gain settings after daily use for extended period of time. Test box electroacoustic measurements of hearing aid done at user gain settings after daily use for extended period of time. Results will be compared to baseline electroacoustic measures taken on day 1 of study. A "pass" means that devices were within tolerance levels (per ANSI S3.22-2014) of baseline measures. A "fail" means that devices were not within tolerance levels of one or more baseline measures (i.e. output, gain, frequency range, total harmonic distortion, or equivalent input noise level).
Time Frame
Day 90 of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adults with mild to moderate severe sensorineural hearing loss
Adults who were able to incorporate some type of physical activity into their day (i.e walking, excercise, gardening, etc.)
Exclusion Criteria:
Unable or unwilling to wear study devices during a home trial
Unable or unwilling to come to lab for study visits
Facility Information:
Facility Name
Sonova
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60504
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hearing Aid Quality and Reliability Study
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