N/A Completed N=28 Randomized Double-blind Treatment

Fitting Strategy Study

Hearing Loss, Sensorineural

Source: ClinicalTrials.gov NCT04972162 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2025

Primary outcomePrimary: Abbreviated Profile of Hearing Aid Benefit (APHAB) — 12.7; 13.18; 11.17; 12.22 score on a scale — p=0.38

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Abbreviated Profile of Hearing Aid Benefit (APHAB)	12.7; 13.18; 11.17; 12.22; 11.43; 12.49	0.38

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04972162). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.