Clinical Evaluation of the RH210 Hearing Aid
Key facts
- Where
- Macquarie Park, AustraliaSee the site
Where in Australia
- National Acoustic LaboratoriesMacquarie Park, AustraliaContact: Bettina Turnbull, AuDTaking people
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
- NCT07572357
- Record updated
- 29 May 2026
- Original description
The RH210A is an air-conduction hearing aid designed for adults with perceived mild-to-moderate sensorineural hearing loss. The purpose of this clinical investigation is to generate objective and subjective evidence of the clinical performance and safety of the device.Read full original descriptionShow less
Clinical Evaluation of the RH210 Hearing Aid Software Used With RH210A Device in Adults With Perceived Mild-to-Moderate Hearing Loss
The RH210A is an air-conduction hearing aid designed for adults with perceived mild-to-moderate sensorineural hearing loss. The purpose of this clinical investigation is to generate objective and subjective evidence of the clinical performance and safety of the device.
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.