Clinical Evaluation of the RH210 Hearing Aid

NCT07572357 | Not Yet Recruiting

• 1 other identifier: NAL C26.02
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hearing Impairment, Sensorineural; Perceived Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Aided vs unaided pure-tone audiogram (PTA) measured in dBSPL

  Aided audiogram with both the investigational and control device measured at 500, 1000, 2000 and 4000Hz in dBSPL. Compared with unaided audiogram measured at the same frequencies in dBSPL. Measured conducted in the sound field in a sound isolated room with warble tones presented from 0 degrees azimuth.

  Day 1 (Visit 1) and Day 7 (Visit 2)

Secondary Outcomes (3)

• Speech understanding in background noise (BKB-SIN; AUS)

  Day 1 (Visit 1) and Day 7 (Visit 2)

• Real Ear Measure Measurement (REIG)

  Day 1 (Visit 1) and Day 7 (Visit 2)

• Moderated walk to evaluate simulated "real world benefit" (Ecological Momentary Assessment (EMA): NAL Australia).

  Day 1 (Visit 1) and Day 7 (Visit 2)

Other Outcomes (1)

• Usability of RH210 using the System Usability Survey (SUS: NAL)

  Day 1 (Visit 1) and Day 7 (Visit 2)

Study Arms (2)

All participants

OTHER

Trial device assessment in first appointment, comparator in second appointment

Device: Investigational device (RH210A); Device: Apple AirPods Pro (2nd Generation) with Hearing Aid Feature (HAF)

All Participants

OTHER

Comparator in appointment one, trial device in appointment 2

Device: Investigational device (RH210A); Device: Apple AirPods Pro (2nd Generation) with Hearing Aid Feature (HAF)

Interventions

Investigational device (RH210A) DEVICE

Over the counter device

All Participants; All participants

Apple AirPods Pro (2nd Generation) with Hearing Aid Feature (HAF) DEVICE

FDA cleared OTC device (Control arm)

All Participants; All participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rehear Audiology Company LTD: lead
• Global Edge Medtech Consulting: collaborator
• National Acoustic Laboratories: collaborator

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bettina Turnbull, Doctor of Audiology

  National Acoustic Laboratories

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marisa Poulos, Master of Audiology

CONTACT

+61 2 9412 6872; marisa.poulos@nal.gov.au

Sanna Hou, Master of Audiology

CONTACT

+61 2 9412 6872; sann.hou@nal.gov.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, controlled, within-subject crossover study designed to evaluate the clinical performance, usability, and safety of the RH210 hearing aid and software in adults with perceived mild-to-moderate hearing loss. The study directly compares the performance of the investigation device with both unaided listening and a legally marketed predicate device Apple AirPods Pro (2nd Generation) with Hearing Aid Feature (HAF) under identical, clinically relevant conditions.

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: May 7, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share