RH210A hearing aid performance in adults with mild-to-moderate hearing loss

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional investigation evaluates the RH210A air-conduction hearing aid in adults who perceive mild-to-moderate hearing difficulty. The primary goal is to show a clinically meaningful improvement in speech understanding in noise when using RH210A versus unaided listening, measured with the BKB-SIN test. Participants will use the device alongside Apple AirPods Pro (2nd Gen) with Hearing Aid Features and complete two in-person visits. The key endpoint is the mean 2 dB or greater improvement in SNR with RH210A compared to unaided listening. Safety and device performance will be monitored throughout the study.

Why it matters

Who can join: the full rules

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

Where it's running

• National Acoustic Laboratories
  Macquarie Park, New South Wales, Australia Recruiting

Study contacts

• Principal investigator: Bettina Turnbull, Doctor of Audiology — National Acoustic Laboratories
• Study coordinator: Marisa Poulos, Master of Audiology
• Email: marisa.poulos@nal.gov.au
• Phone: +61 2 9412 6872

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.