Clinical Evaluation of Hearing Aid OTC Self-Assessment Methods for Adults With Perceived Mild-to-Moderate Hearing Loss | NCT07738237

NCT07738237

Overview

NCT ID: NCT07738237
Lead Sponsor: Rehear Audiology Company LTDINDUSTRY
Official Title: Clinical Evaluation of Two Rehear RH210 Self-Assessment Methods for Generating NAL-R-Based Prescribed Gain Compared With Conventional Audiometry in Adults With Perceived Mild-to-Moderate Hearing Loss
Brief Summary: The goal of this clinical trial is to compare two methods of self assessment of hearing with conventional audiometry in an OTC Hearing Aid for adults with perceived mild to moderate hearing loss. The main questions it aims to answer are:

To evaluate agreement between prescribed gain outputs generated from conventional audiometry and those generated from the self-assessment response method.

Determine whether either self-assessment response method provides acceptable estimated audibility.

Evaluate participant preference between the detection response method and the audibility-release response method.

Researchers will compare the two novel methods with conventional audiometry to determine levels of agreement.

Participants will self assess their hearing methods using two novel methods of hearing assessment as well as receive a conventional audiometric evaluation of hearing levels.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Aug 3, 2026Actual
Start Date: Aug 15, 2026Estimated
Primary Completion Date: Oct 1, 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Age 18 years

Self-perceived mild-to-moderate hearing difficulties/ hearing loss

Competent smartphone use (able to complete self-fitting via the app)

Able and willing to provide informed consent

HHIA screening consistent with perceived hearing difficulty

Willingness and ability to attend two in-person research appointments

Ability to operate a SmartPhone

Exclusion Criteria:

Conductive or mixed hearing loss

Occluding cerumen

Otologic disease/ active ear pathology

Severe or profound hearing loss (PTA >S0dBHL) (WHO, 2021)

Presence of (red-flag) conditions relevant to OTC hearing aid use (per 21 CFR 801.421)

Visible deformity of the ear (congenital or traumatic).

Fluid, pus, or blood coming from the ear (e.g., active drainage).

Sudden or rapidly progressive hearing loss within the recent past (often defined as within ~90 days).

Any acute or chronic dizziness or vertigo associated with hearing issues.

Pain or discomfort in or around the ear.

Visible evidence of significant cerumen (ear wax) accumulation or foreign body in the ear canal.

Unilateral hearing loss of sudden onset or large asymmetry between ears.

Audiometric air-bone gap suggestive of possible conductive pathology (e.g., gap equal or more than 15 dB at key frequencies)

Visible evidence of significant cerumen (ear wax) accumulation or foreign body in the ear canal.

Unilateral hearing loss of sudden onset or large asymmetry between ears

Exclusion Criteria:

-

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 24Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Marisa Poulos, Master of AudiologyContact
marisa.poulos@nal.gov.au

Overview

Status and Timeline

Participation Criteria

Study Plan

Contacts and Locations

Similar Studies