NCT04972162

Fitting Strategy Study

Web App Fitting Strategy Validation NSR Device Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: WSAUD A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	Web App Strategy Fitting	Web App Strategy fitting of hearing aids
DEVICE	Standard-of-care Fitting	Standard-of-care fitting of hearing aids

Timeline

• Start date: 2021-07-26
• Primary completion: 2021-11-12
• Completion: 2021-11-12
• First posted: 2021-07-22
• Last updated: 2025-09-30
• Results posted: 2025-09-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study