Hearing Loss, SensorineuralNCT04972162
Fitting Strategy Study
A study testing Web App Strategy Fitting and Standard-of-care Fitting in people with Hearing Loss, Sensorineural, run by WSAUD A/S at 1 site in United States.
Trial summary
To be conducted with adult participants with mild-to-moderate hearing loss to validate the effectiveness of the Web App fitting strategy. Validation measures participant's perceived hearing aid benefit when using the Web App fitted hearing aids and when using standard-of-care fitted hearing aids. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Sensorineural
- What is being tested?
- Web App Strategy Fitting and Standard-of-care Fitting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2021to 12 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 years of age or older,
- 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
Who cannot join
- Hearing aids do not fit into the person's ears with any of the offered silicone 'Click Sleeves' instant ear tips.
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Dakota, USD Speech and Hearing Clinic
Vermillion, South Dakota, 57069
About this study
Official title: Web App Fitting Strategy Validation NSR Device Study
To be conducted with adult participants with mild-to-moderate hearing loss to validate the effectiveness of the Web App fitting strategy. Validation measures participant's perceived hearing aid benefit when using the Web App fitted hearing aids and when using standard-of-care fitted hearing aids.
Read the detailed description
A prospective, randomized controlled, adaptive design, non-inferiority, pre-market and NSR device study. Completed in 26 adult subjects with mild-to-moderate hearing loss to validate the effectiveness of a Web App fitting strategy. Validation measured subject´s perceived hearing aid benefit when using the Web App fitted hearing aids and when using standard-of-care fitted hearing aids.
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
- Hearing Loss, Sensorineural
- Being tested
- Web App Strategy Fitting, Standard-of-care Fitting
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web App Strategy FittingDevice
Web App Strategy fitting of hearing aids
Standard-of-care FittingDevice
Standard-of-care fitting of hearing aids
| Study group | Role | What they receive |
|---|---|---|
| Web-App-fitted Hearing Aid, Then Standard-of-care fitted Hearing Aid | Experimental | 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. Receives: Device: Web App Strategy Fitting; Device: Standard-of-care Fitting |
| Standard-of-care-fitted Hearing Aid, Then Web-App-fitted hearing Aid | Experimental | 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. Receives: Device: Web App Strategy Fitting; Device: Standard-of-care Fitting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abbreviated Profile of Hearing Aid Benefit (APHAB)
The APHAB consists of 24 questions across 4 subscales: Ease of Communication (EC), Background Noise (BN), Reverberation (RV), and Aversiveness (AV), assessing hearing difficulties in daily situations reported as percentage of problems (0-100%, 100% = highest number of problems). It evaluates hearing aid (HA) benefit by subtracting the reported % of problems with HA from without HA, yielding scores from 0 (no benefit) to 100 (maximum benefit) in each subscale. The study focuses on the communication subscales (EC, BN, RV) and calculates benefit score differences for each subscale after using A) Web-App-fitted and B) standard-of-care-fitted HAs. The difference-of-benefit scores are compared to non-inferiority margins from Cox\&Alexander (Ear\&Hearing 1995). Differences-in-benefit scores range from -100 to 100, with negative scores indicating greater benefit with Web-App-fitted HAs, 0 indicating identical benefit and higher scores indicating greater benefit with standard-of-care fitting.
Measured: 14-17 Days hearing aid wearing time per fitting type
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start26 Jul 2021
- Primary completion12 Nov 2021
- Study completion12 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- WSAUD A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of South Dakota
- Responsible party
- Sponsor
- Investigators
- Lindsey Jorgensen, Principal investigator, University of South Dakota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972162
- Sponsor's protocol ID
- D00232675
- Status last verified
- Sep 2025
- First submitted
- 12 Jul 2021
- Last updated
- 30 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web App Fitting Strategy Validation NSR Device Study
- ClinicalTrials.gov ID
- NCT04972162
- Acronym / sponsor ID
- D00232675
- Conditions
- Hearing Loss, Sensorineural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- WSAUD A/SIndustry (pharma, biotech, devices)
- Collaborators
- University of South Dakota
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- 12 Nov 2021 (actual)
- Study completion
- 12 Nov 2021 (actual)
- First posted
- 22 Jul 2021 (actual)
- Results
- Posted 30 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To be conducted with adult participants with mild-to-moderate hearing loss to validate the effectiveness of the Web App fitting strategy. Validation measures participant's perceived hearing aid benefit when using the Web App fitted hearing aids and when using standard-of-care fitted hearing aids.
Detailed description
A prospective, randomized controlled, adaptive design, non-inferiority, pre-market and NSR device study. Completed in 26 adult subjects with mild-to-moderate hearing loss to validate the effectiveness of a Web App fitting strategy. Validation measured subject´s perceived hearing aid benefit when using the Web App fitted hearing aids and when using standard-of-care fitted hearing aids.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-App-fitted Hearing Aid, Then Standard-of-care fitted Hearing Aid | Experimental | Device: Web App Strategy Fitting, Device: Standard-of-care FittingPatients 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. |
| Standard-of-care-fitted Hearing Aid, Then Web-App-fitted hearing Aid | Experimental | Device: Web App Strategy Fitting, Device: Standard-of-care FittingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults 18 years of age or older,
- 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.
Key exclusion criteria (9 listed)
- Hearing aids do not fit into the person's ears with any of the offered silicone 'Click Sleeves' instant ear tips.
- Abnormal conditions:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web App Strategy FittingWeb App Strategy fitting of hearing aids | Device | Standard-of-care-fitted Hearing Aid, Then Web-App-fitted hearing Aid, Web-App-fitted Hearing Aid, Then Standard-of-care fitted Hearing Aid |
| Standard-of-care FittingStandard-of-care fitting of hearing aids | Device | Standard-of-care-fitted Hearing Aid, Then Web-App-fitted hearing Aid, Web-App-fitted Hearing Aid, Then Standard-of-care fitted Hearing Aid |
Primary outcome
Abbreviated Profile of Hearing Aid Benefit (APHAB)
Time frame: 14-17 Days hearing aid wearing time per fitting type
The APHAB consists of 24 questions across 4 subscales: Ease of Communication (EC), Background Noise (BN), Reverberation (RV), and Aversiveness (AV), assessing hearing difficulties in daily situations reported as percentage of problems (0-100%, 100% = highest number of problems). It evaluates hearing aid (HA) benefit by subtracting the reported % of problems with HA from without HA, yielding scores from 0 (no benefit) to 100 (maximum benefit) in each subscale. The study focuses on the communication subscales (EC, BN, RV) and calculates benefit score differences for each subscale after using A) Web-App-fitted and B) standard-of-care-fitted HAs. The difference-of-benefit scores are compared to non-inferiority margins from Cox\&Alexander (Ear\&Hearing 1995). Differences-in-benefit scores range from -100 to 100, with negative scores indicating greater benefit with Web-App-fitted HAs, 0 indicating identical benefit and higher scores indicating greater benefit with standard-of-care fitting.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindsey Jorgensen principal investigator
University of South Dakota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web App Strategy Fitting and Standard-of-care Fitting in people with Hearing Loss, Sensorineural, run by WSAUD A/S at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abbreviated Profile of Hearing Aid Benefit (APHAB) (time frame: 14-17 Days hearing aid wearing time per fitting type). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025; AzTrials last refreshed its copy on 30 Oct 2026.