Fitting Strategy Study

September 9, 2025 updated by: WSAUD A/S

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Dakota
      • Vermillion, South Dakota, United States, 57069
        • University of South Dakota, USD Speech and Hearing Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
    • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Web App Strategy Fitting
Web App Strategy fitting of hearing aids
Device: Standard-of-care Fitting
Standard-of-care fitting of hearing aids
Experimental: 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.
Device: Web App Strategy Fitting
Web App Strategy fitting of hearing aids
Device: Standard-of-care Fitting
Standard-of-care fitting of hearing aids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
14-17 Days hearing aid wearing time per fitting type

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

WSAUD A/S

Collaborators

University of South Dakota

Investigators

  • Principal Investigator: Lindsey Jorgensen, University of South Dakota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2021

Primary Completion (Actual)

November 12, 2021

Study Completion (Actual)

November 12, 2021

Study Registration Dates

First Submitted

July 12, 2021

First Submitted That Met QC Criteria

July 12, 2021

First Posted (Actual)

July 22, 2021

Study Record Updates

Last Update Posted (Estimated)

September 30, 2025

Last Update Submitted That Met QC Criteria

September 9, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D00232675

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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