Hearing Impairment, SensorineuralNCT07572357
Clinical Evaluation of the RH210 Hearing Aid
A study testing Investigational device (RH210A) and Apple AirPods Pro (2nd Generation) with Hearing Aid Feature (HAF) in people with Hearing Impairment, Sensorineural and Perceived Hearing Loss, run by Rehear Audiology Company LTD at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Impairment, Sensorineural, Perceived Hearing Loss
- What is being tested?
- Investigational device (RH210A) and Apple AirPods Pro (2nd Generation) with Hearing Aid Feature (HAF)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAustralia
- Study dates
- 11 Apr 2026to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
National Acoustic Laboratories
Macquarie Park, New South Wales
Bettina Turnbull, AuD, Bettina.Turnbull@nal.gov.au
Bettina Turnbull, AuD
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Investigational device (RH210A), Apple AirPods Pro (2nd Generation) with Hearing Aid Feature (HAF)
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational device (RH210A)Device
Over the counter device
Apple AirPods Pro (2nd Generation) with Hearing Aid Feature (HAF)Device
FDA cleared OTC device (Control arm)
| Study group | Role | What they receive |
|---|---|---|
| All participants | Other | Trial device assessment in first appointment, comparator in second appointment Receives: 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 Receives: Device: Investigational device (RH210A); Device: Apple AirPods Pro (2nd Generation) with Hearing Aid Feature (HAF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 (Visit 1) and Day 7 (Visit 2)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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 :
- Library (~40 dBA) very low or no noise
- Office (~50 dBA) with low level noise
- Outdoor parkway (~55 dBA) with environmental noise
- Traffic / street (~70-75 dBA) with traffic noise
- 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.
Measured: Day 1 (Visit 1) and Day 7 (Visit 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start11 Apr 2026
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Impairment, SensorineuralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rehear Audiology Company LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Global Edge Medtech Consulting, National Acoustic Laboratories
- Responsible party
- Sponsor
- Investigators
- Bettina Turnbull, Doctor of Audiology, Principal investigator, National Acoustic Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572357
- Sponsor's protocol ID
- NAL C26.02
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study is a commercial sponsor investigation of a product that is not yet cleared by regulatory.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the RH210 Hearing Aid Software Used With RH210A Device in Adults With Perceived Mild-to-Moderate Hearing Loss
- ClinicalTrials.gov ID
- NCT07572357
- Acronym / sponsor ID
- NAL C26.02
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Rehear Audiology Company LTDIndustry (pharma, biotech, devices)
- Collaborators
- Global Edge Medtech Consulting, National Acoustic Laboratories
- Study start
- 11 Apr 2026 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| All participants | Other | Device: Investigational device (RH210A), Device: Apple AirPods Pro (2nd Generation) with Hearing Aid Feature (HAF)Trial device assessment in first appointment, comparator in second appointment |
| All Participants | Other | Device: Investigational device (RH210A), Device: Apple AirPods Pro (2nd Generation) with Hearing Aid Feature (HAF)Comparator in appointment one, trial device in appointment 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational device (RH210A)Over the counter device | Device | All Participants, All participants |
| Apple AirPods Pro (2nd Generation) with Hearing Aid Feature (HAF)FDA cleared OTC device (Control arm) | Device | All Participants, All participants |
Primary outcome
Aided vs unaided pure-tone audiogram (PTA) measured in dBSPL
Time frame: Day 1 (Visit 1) and Day 7 (Visit 2)
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.
3 secondary outcomes
Speech understanding in background noise (BKB-SIN; AUS)
Time frame: Day 1 (Visit 1) and Day 7 (Visit 2)
Real Ear Measure Measurement (REIG)
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).
Time frame: Day 1 (Visit 1) and Day 7 (Visit 2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No. The study is a commercial sponsor investigation of a product that is not yet cleared by regulatory.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bettina Turnbull, Doctor of Audiology principal investigator
National Acoustic Laboratories
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational device (RH210A) and Apple AirPods Pro (2nd Generation) with Hearing Aid Feature (HAF) in people with Hearing Impairment, Sensorineural and Perceived Hearing Loss, run by Rehear Audiology Company LTD at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marisa Poulos, Master of Audiology (+61 2 9412 6872, marisa.poulos@nal.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aided vs unaided pure-tone audiogram (PTA) measured in dBSPL (time frame: Day 1 (Visit 1) and Day 7 (Visit 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.