Hearing Aid Quality and Reliability Study
Hearing Aid Quality Check and Reliability Study
1 other identifier
interventional
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 8, 2021
CompletedFirst Submitted
Initial submission to the registry
June 11, 2021
CompletedFirst Posted
Study publicly available on registry
August 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 13, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2021
CompletedResults Posted
Study results publicly available
May 17, 2023
CompletedMay 17, 2023
April 1, 2023
3 months
June 11, 2021
March 31, 2023
April 24, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
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.
Day 1 of study
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).
Day 45 of study
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).
Day 90 of study
Study Arms (1)
Hearing Aid
EXPERIMENTALParticipants will wear Phonak rechargeable Audeo hearing aids
Interventions
Eligibility Criteria
You may qualify if:
- 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.)
You may not qualify if:
- Unable or unwilling to wear study devices during a home trial
- Unable or unwilling to come to lab for study visits
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sonova AGlead
Study Sites (1)
Sonova
Aurora, Illinois, 60504, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Research
- Organization
- Phonak Audiology Research Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2021
First Posted
August 9, 2021
Study Start
June 8, 2021
Primary Completion
September 13, 2021
Study Completion
October 31, 2021
Last Updated
May 17, 2023
Results First Posted
May 17, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share