Clinical Evaluation of Hearing Aid OTC Self-Assessment Methods for Adults With Perceived Mild-to-Moderate Hearing Loss
Key facts
- Where
- Macquarie Park, AustraliaSee the site
Where in Australia
- National Acoustic LaboratoriesMacquarie Park, AustraliaContact: Bettina Turnbull, AuDNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Rehear Audiology Company LTD
- Trial code
- NCT07738237
- Record updated
- 3 August 2026
- Original description
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:Read full original descriptionShow less
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
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:
1. To evaluate agreement between prescribed gain outputs generated from conventional audiometry and those generated from the self-assessment response method. 2. Determine whether either self-assessment response method provides acceptable estimated audibility. 3. 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.
Inclusion: 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: Otologic disease/ active ear pathology; Presence of (red-flag) conditions relevant to OTC hearing aid use (per 21 CFR 801.421); Conductive or mixed hearing loss; Occluding cerumen; Severe or profound hearing loss (PTA >S0dBHL) (WHO, 2021); 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; -.