Study Results
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View full resultsBasic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2021-07-26
2021-11-12
Brief Summary
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Detailed Description
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The adaptive study design began with a cross-over design of the first 12 subjects. At the interim analysis, the possibility of an interaction effect was evaluated as a nuisance parameter. In the absence of an interaction effect, the study was completed in cross-over design.
The standard-of-care fitted hearing aids were fitted to National Acoustic Laboratories Nonlinear Version 2 (NAL-NL2) prescriptive targets, verified by probe-mic real-ear measures (REM). The null hypothesis (H0) was that subject´s perceived hearing aids benefit using Web App fitted hearing aids is inferior to perceived benefit using standard-of-care fitted hearing aids, and the alternative hypothesis (Ha) was that subject´s perceived hearing aids benefit using Web App fitted hearing aids is non-inferior to that using standard-of-care fitted hearing aids.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Web-App-fitted Hearing Aid, Then Standard-of-care fitted Hearing Aid
Patients self-fitted the web-app-fitted hearing aids and wore them in a home-trial for 14 days. After a washout period of 5 days, they were fitted by a hearing care professional with the Standard-of-care fitted hearing aids and wore those in a home-trial for 14 days.
Web App Strategy Fitting
Web App Strategy fitting of hearing aids
Standard-of-care Fitting
Standard-of-care fitting of hearing aids
Standard-of-care-fitted Hearing Aid, Then Web-App-fitted hearing Aid
Patients were fitted by a hearing care professional with the Standard-of-care fitted hearing aids and wore them in a home-trial for 14 days. After a washout period of 5 days, they self-fitted the web-app-fitted hearing aids and wore those in a home-trial for 14 days.
Web App Strategy Fitting
Web App Strategy fitting of hearing aids
Standard-of-care Fitting
Standard-of-care fitting of hearing aids
Interventions
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Web App Strategy Fitting
Web App Strategy fitting of hearing aids
Standard-of-care Fitting
Standard-of-care fitting of hearing aids
Eligibility Criteria
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Inclusion Criteria
* Self-perceived mild to moderate hearing impairment,
* Signed informed consent form (ICF),
* Fluent in English listening and reading comprehension,
* With or without prior experience with hearing aids. At least four subjects and maximum 30% of the total number of subjects enrolled in this study will have prior hearing aid experience.
* Measured audiogram with at least four of the test frequencies 500 Hz, 1000 Hz, 2000 Hz, 3000 Hz, and 4000 Hz within fitting range of Web App fitted hearing aid
Exclusion Criteria
* Abnormal conditions:
* Severe hearing loss or deafness in at least one ear.
* A steep decline in hearing ability within the last 90 days in one or both ears.
* Active discharge within the last 90 days.
* Dizziness.
* A visible deformity of the ear.
* Pain, or discomfort in the ear, or significant ear wax accumulation.
* Audiometric air-bone gap equal to or greater than 15 decibels at 500 hertz Hz, 1,000 Hz, and 2,000 Hz.
18 Years
ALL
No
Sponsors
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University of South Dakota
OTHER
WSAUD A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Lindsey Jorgensen
Role: PRINCIPAL_INVESTIGATOR
University of South Dakota
Locations
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University of South Dakota, USD Speech and Hearing Clinic
Vermillion, South Dakota, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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D00232675
Identifier Type: -
Identifier Source: org_study_id
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