An interventional study of Investigational device (RH210A) and Apple AirPods Pro (2nd Generation) with Hearing Aid Feature (HAF) in Hearing Impairment, Sensorineural and Perceived Hearing Loss, sponsored by Rehear Audiology Company LTD. Recruiting at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-29.
Sponsored by Rehear Audiology Company LTD · Not applicable, Interventional, and Treatment
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.
The primary objective of this clinical investigation is to demonstrate that the RH210A device provides a clinically meaningful improvement in speech understanding in noise compared with unaided listening in adults with perceived mild-to-moderate hearing loss.
Speech-in-noise performance will be assessed using the BKB-SIN (Australian version), which quantifies the change in signal-to-noise ratio required for sentence recognition. The primary endpoint is defined as the within-subject difference between unaided and RH210 conditions (change in SNR = Unaided - RH210). A successful outcome is defined as a mean improvement of equal to or more than 2 dB in SNR with RH210 compared to unaided listening.
371 studies on the registry are indexed under Hearing Loss, Sensorineural; 112 are open to participants now.
This study's planned enrollment of 24 is below the median of 32 across 264 interventional studies indexed under Hearing Loss, Sensorineural.
Browse Hearing Loss, Sensorineural studies →Rehear Audiology Company LTD is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
Comparator in appointment one, trial device in appointment 2
Device: Investigational device (RH210A) · Device: Apple AirPods Pro (2nd Generation) with Hearing Aid Feature (HAF)
Over the counter device
FDA cleared OTC device (Control arm)
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.
Time frame: Day 1 (Visit 1) and Day 7 (Visit 2)
Speech understanding in background noise (BKB-SIN; AUS)
Participants will be asked to perform a speech in noise test. Participants will be presented with speech sentences and asked to recall the words they hear. The target stimuli will comprise of BKB sentences (Australian English version), and the noise will be spatially diffuse speech babble. The noise level will be fixed and the speech level will be adaptively changed (Keidser et al, 2013) to determine the speech reception threshold at 50% in dB SNR recall performance, using phonemic scoring. The test conditions, unaided and aided, will comprise of four repeated measures each, with 32 sentence repeats, conducted at 50% threshold. The order of conditions will be randomized across participant. The device will be set to 'Immersive Conversation' mode. For the AirPods Pro 2, the Hearing Aid setting will be toggled, and the AirPods set in Transparency mode.
Time frame: Day 1 (Visit 1) and Day 7 (Visit 2)
Real Ear Measure Measurement (REIG)
Measurement of the Real Ear Insertion Gain (REIG) for the control and intervention device. Output will be compared with the prescribed NAL-R target values.
Time frame: Day 1 (Visit 1) and Day 7 (Visit 2)
Moderated walk to evaluate simulated "real world benefit" (Ecological Momentary Assessment (EMA): NAL Australia).
Participants will use the to use the devices in a controlled, moderated, 60 minute walk. The walk will cover five key listening environments and : 1. Library (\~40 dBA) very low or no noise 2. Office (\~50 dBA) with low level noise 3. Outdoor parkway (\~55 dBA) with environmental noise 4. Traffic / street (\~70-75 dBA) with traffic noise 5. Café / food court (\~65-70 dBA) with multi-talker babble noise Performance will be evaluated using the Ecological Momentary Assessment (EMA) (NAL Australia). The study participants will provide feedback by selecting a rating on a five-point Likert scale for questions related to subjective impressions for speech intelligibility, listening effort, loudness/comfort and their aided/unaided preference while using the trial device or control device during the moderated walk.
Time frame: Day 1 (Visit 1) and Day 7 (Visit 2)
Usability of RH210 using the System Usability Survey (SUS: NAL)
Assess the subjective usability of the RH210 hearing aid software and application workflow in real-world use using the System Usability Survey (SUS) from the National Acoustic Laboratory (NAL). This is to gather data for a proposed human factors evaluation. The scoring is * Poor: Scores below 51 are considered poor. * Average Score: 68. * Above Average: \> 68. * Below Average: \< 68. * Good/Excellent: Scores over 79 are considered good, while 80.3 or higher is an A grade.
Time frame: Day 1 (Visit 1) and Day 7 (Visit 2)
Plan to share: No — The study is a commercial sponsor investigation of a product that is not yet cleared by regulatory.
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Rehear Audiology Company LTD