Fitting Strategy Study

NCT04972162 | Completed Results FDA Device

• 1 other identifier: D00232675
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hearing Loss, Sensorineural

Outcome Measures

Primary Outcomes (1)

• 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.

  14-17 Days hearing aid wearing time per fitting type

Study Arms (2)

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.

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.

Device: Web App Strategy Fitting; Device: Standard-of-care Fitting

Interventions

Web App Strategy Fitting DEVICE

Web App Strategy fitting of hearing aids

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 Fitting DEVICE

Standard-of-care fitting of hearing aids

Standard-of-care-fitted Hearing Aid, Then Web-App-fitted hearing Aid; Web-App-fitted Hearing Aid, Then Standard-of-care fitted Hearing Aid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• WSAUD A/S: lead
• University of South Dakota: collaborator

Study Sites (1)

University of South Dakota, USD Speech and Hearing Clinic

Vermillion, South Dakota, 57069, United States

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Veronika Littmann
• Organization: WSAUDAS

veronika.littmann@wsa.com

+4991313080

Study Officials

• Lindsey Jorgensen

  University of South Dakota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The masking only done at the final visit.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 22, 2021
• Study Start: July 26, 2021
• Primary Completion: November 12, 2021
• Study Completion: November 12, 2021
• Last Updated: September 30, 2025
• Results First Posted: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)