Fitting Strategy Study

WS Audiology (WSAUD)

Status: Completed

Conditions: Hearing Loss, Sensorineural

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04972162

D00232675

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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28 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Device: Standard-of-care Fitting

Device: Web App Strategy Fitting

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

Experimental group

Description:

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.

Treatment:

Device: Standard-of-care Fitting

Device: Web App Strategy Fitting