Sensorineural Hearing LossNCT07738237
Clinical Evaluation of Hearing Aid OTC Self-Assessment Methods for Adults With Perceived Mild-to-Moderate Hearing Loss
A study testing OTC Hearing Aid Self Fitting App and Audiometry in people with Sensorineural Hearing Loss and Perceived Hearing Loss, run by Rehear Audiology Company LTD at 1 site in Australia.
Trial summary
The goal of this clinical trial is to compare two methods of self assessment of hearing with conventional audiometry in an OTC Hearing Aid for adults with perceived mild to moderate hearing loss. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sensorineural Hearing Loss, Perceived Hearing Loss, Hearing Impairment
- What is being tested?
- OTC Hearing Aid Self Fitting App and Audiometry
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAustralia
- Study dates
- 15 Aug 2026to 1 Oct 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).
Show all 16Show fewer
- 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
National Acoustic Laboratories
Macquarie Park, New South Wales, 2113
Bettina Turnbull, AuD, +61 2 9412 6872, Bettina.Turnbull@nal.gov.au
About this study
Official title: Clinical Evaluation of Two Rehear RH210 Self-Assessment Methods for Generating NAL-R-Based Prescribed Gain Compared With Conventional Audiometry in Adults With Perceived Mild-to-Moderate Hearing Loss
The goal of this clinical trial is to compare two methods of self assessment of hearing with conventional audiometry in an OTC Hearing Aid for adults with perceived mild to moderate hearing loss. The main questions it aims to answer are:
- To evaluate agreement between prescribed gain outputs generated from conventional audiometry and those generated from the self-assessment response method.
- Determine whether either self-assessment response method provides acceptable estimated audibility.
- Evaluate participant preference between the detection response method and the audibility-release response method.
Read more
Researchers will compare the two novel methods with conventional audiometry to determine levels of agreement.
Participants will self assess their hearing methods using two novel methods of hearing assessment as well as receive a conventional audiometric evaluation of hearing levels.
Read the detailed description
The purpose of this clinical investigation is to evaluate two RH210 hearing aid software self-assessment response methods used to generate NAL-R-based prescribed gain for adults with perceived mild-to-moderate hearing loss. The study will compare prescribed gain outputs derived from each RH210 self-assessment response method with prescribed gain outputs derived from conventional audiometry using the same NAL-R prescription approach. The study will also assess whether the resulting prescribed gain provides estimated audibility using Speech Intelligibility Index (SII) analysis, and will evaluate participant preference between the two self-assessment response methods. The RH210A is an air-conduction hearing aid designed for adults with perceived mild-to-moderate sensorineural hearing loss.
The two RH210 self-assessment response methods evaluated in this study are:
- Detection response method (Option 1): the participant presses a response control when they hear the tone or beep.
- Audibility-release response method (Option 2): the participant maintains a press while the tone or beep is audible and releases the response control when they no longer hear it.
The study is designed to:
- Evaluate agreement between NAL-R prescribed gain outputs generated from conventional audiometry and NAL-R prescribed gain outputs generated from each RH210 self-assessment response method.
- Compare the detection response method and audibility-release response method with respect to prescribed gain agreement by ear and frequency.
- Assess estimated audibility associated with the self-assessment-derived NAL-R prescriptions using Speech Intelligibility Index (SII) analysis.
- Determine whether either self-assessment response method provides acceptable estimated audibility, including in cases where prescribed gain does not exactly match the conventional-audiometry-derived NAL-R prescription.
- Evaluate participant preference between the detection response method and the audibility-release response method.
- Assess general agreement, completeness, invalid-test rate, usability and response consistency for each self-assessment response method.
- Support validation of the Rehear assessment-to-fitting pathway without positioning the RH210 self-assessment function as a diagnostic audiometer.
This study is not intended to establish Human Factors performance. However, observations arising during execution of the assessment workflow may identify opportunities to improve the user interface, workflow or user guidance before the final Human Factors validation study. These observations are exploratory development outputs and are not formal study endpoints.
- Being tested
- OTC Hearing Aid Self Fitting App, Audiometry
- Keywords
- OTC Hearing Aid, hearing impairment, hearing aid
- Medical subject headings
- Hearing Loss, Sensorineural, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTC Hearing Aid Self Fitting AppDevice
The Investigational Medical Device (IMD) consists of the RH210 hearing aid software self-test function accessed through the Rehear smartphone application and used in combination with the RH210A compatible in-ear hardware platform.
For this clinical investigation, the RH210A hardware platform is used to present calibrated test sounds (pure tones) to the participant during the app-based self-test. The RH210A is not being evaluated as a diagnostic audiometer, and the study is not designed to evaluate the hearing aid's amplification performance.
The two RH210 self-test response methods evaluated in this study are:
- Detection response method: the participant presses the response control when they hear the tone or beep (Mode A).
- Audibility-release response method: the participant maintains the response control while the tone or beep is audible and releases the response control when they no longer hear the tone or beep (Mode B).
AudiometryProcedure or surgery
The comparator for this clinical investigation is conventional manual pure-tone audiometry performed in accordance with ANSI/ASA S3.21-2004 (R2023), Methods for Manual Pure-Tone Threshold Audiometry, followed by generation of a NAL-R-based prescribed gain output.
| Study group | Role | What they receive |
|---|---|---|
| Conventional manual pure-tone audiometry | Active comparator | Conventional manual pure-tone audiometry Receives: Procedure: Audiometry |
| Mode A | Experimental | RH210 self-test method 1: detection response method, where the participant presses when they hear the tone or beep Receives: Device: OTC Hearing Aid Self Fitting App |
| Mode B | Experimental | RH210 self-test method 2: audibility-release response method, where the participant releases the response control when they no longer hear the tone or beep Receives: Device: OTC Hearing Aid Self Fitting App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement of NAL-R prescribed gain outputs (dB) between the comparator conditions
The primary endpoint is the agreement of NAL-R prescribed gain outputs (dB), by ear (R/L) and frequency (Hz), between:
- Conventional-audiometry-derived NAL-R prescribed gain (dB), and
- RH210 self-test-derived NAL-R prescribed gain (dB), generated using each of the two RH210 response methods.
The frequency-specific analysis will include: 500 Hz; 1 kHz; 2 kHz; and 4 kHz.
The two RH210 response methods are:
- Detection response method: participant presses when they hear the tone or beep (Mode A).
- Audibility-release response method: participant releases the response control when they no longer hear the tone or beep Mode B).
Measured: Day 1
Secondary outcomes (2)
Difference in Speech Intelligibility Index (SII) and SRT in quiet (CNC words) between the three conditions
The secondary objective is to evaluate whether RH210 self-test-derived NAL-R prescribed gain outputs (dB) provide estimated audibility comparable to the conventional-audiometry-derived NAL-R reference pathway.
The secondary endpoint is the difference in Speech Intelligibility Index / Audibility Index and SRT in quiet between:
(1) The conventional-audiometry-derived NAL-R prescribed gain condition (dB); and (2) Each RH210 self-test-derived NAL-R prescribed gain (dB) condition.
The analysis will be conducted under a pre-specified standard aided speech condition (SRT50% dB), for example adaptive speech in quiet SRT50, with the final method defined in the Statistical Analysis Plan
Measured: Day 1
Number of Participants with Treatment-Related Adverse Events as classified by ISO14155:2026
The secondary safety objective is to assess the safety of participant exposure to the RH210 app-based self-test procedure when the RH210A in-ear hardware platform is used to present test sounds.
Safety will be assessed by the incidence, severity, seriousness and relationship to the investigational device or study procedure of:
- adverse events;
- adverse device effects;
- anticipated adverse device effects;
- discomfort associated with in-ear device use;
- excessive loudness or sound intolerance;
No formal statistical hypothesis is proposed for safety. Safety outcomes will be summarized descriptively.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start15 Aug 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensorineural Hearing LossStudies 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
- Randomised
- Intervention model
- Crossover
- 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
- NCT07738237
- Sponsor's protocol ID
- NAL C26.08
- Status last verified
- Jul 2026
- First submitted
- 26 Jul 2026
- Last updated
- 3 Aug 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 agencies
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Two Rehear RH210 Self-Assessment Methods for Generating NAL-R-Based Prescribed Gain Compared With Conventional Audiometry in Adults With Perceived Mild-to-Moderate Hearing Loss
- ClinicalTrials.gov ID
- NCT07738237
- Acronym / sponsor ID
- NAL C26.08
- Keywords
- OTC Hearing Aid, hearing impairment, hearing aid
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Rehear Audiology Company LTDIndustry (pharma, biotech, devices)
- Collaborators
- Global Edge Medtech Consulting, National Acoustic Laboratories
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 31 Jul 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 goal of this clinical trial is to compare two methods of self assessment of hearing with conventional audiometry in an OTC Hearing Aid for adults with perceived mild to moderate hearing loss. The main questions it aims to answer are:
- To evaluate agreement between prescribed gain outputs generated from conventional audiometry and those generated from the self-assessment response method.
- Determine whether either self-assessment response method provides acceptable estimated audibility.
- Evaluate participant preference between the detection response method and the audibility-release response method.
Researchers will compare the two novel methods with conventional audiometry to determine levels of agreement.
Participants will self assess their hearing methods using two novel methods of hearing assessment as well as receive a conventional audiometric evaluation of hearing levels.
Detailed description
The purpose of this clinical investigation is to evaluate two RH210 hearing aid software self-assessment response methods used to generate NAL-R-based prescribed gain for adults with perceived mild-to-moderate hearing loss. The study will compare prescribed gain outputs derived from each RH210 self-assessment response method with prescribed gain outputs derived from conventional audiometry using the same NAL-R prescription approach. The study will also assess whether the resulting prescribed gain provides estimated audibility using Speech Intelligibility Index (SII) analysis, and will evaluate participant preference between the two self-assessment response methods. The RH210A is an air-conduction hearing aid designed for adults with perceived mild-to-moderate sensorineural hearing loss.
The two RH210 self-assessment response methods evaluated in this study are:
- Detection response method (Option 1): the participant presses a response control when they hear the tone or beep.
- Audibility-release response method (Option 2): the participant maintains a press while the tone or beep is audible and releases the response control when they no longer hear it.
The study is designed to:
- Evaluate agreement between NAL-R prescribed gain outputs generated from conventional audiometry and NAL-R prescribed gain outputs generated from each RH210 self-assessment response method.
- Compare the detection response method and audibility-release response method with respect to prescribed gain agreement by ear and frequency.
- Assess estimated audibility associated with the self-assessment-derived NAL-R prescriptions using Speech Intelligibility Index (SII) analysis.
- Determine whether either self-assessment response method provides acceptable estimated audibility, including in cases where prescribed gain does not exactly match the conventional-audiometry-derived NAL-R prescription.
- Evaluate participant preference between the detection response method and the audibility-release response method.
- Assess general agreement, completeness, invalid-test rate, usability and response consistency for each self-assessment response method.
- Support validation of the Rehear assessment-to-fitting pathway without positioning the RH210 self-assessment function as a diagnostic audiometer.
This study is not intended to establish Human Factors performance. However, observations arising during execution of the assessment workflow may identify opportunities to improve the user interface, workflow or user guidance before the final Human Factors validation study. These observations are exploratory development outputs and are not formal study endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional manual pure-tone audiometry | Active comparator | Procedure: AudiometryConventional manual pure-tone audiometry |
| Mode A | Experimental | Device: OTC Hearing Aid Self Fitting AppRH210 self-test method 1: detection response method, where the participant presses when they hear the tone or beep |
| Mode B | Experimental | Device: OTC Hearing Aid Self Fitting AppRH210 self-test method 2: audibility-release response method, where the participant releases the response control when they no longer hear the tone or beep |
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 (16 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 |
|---|---|---|
| OTC Hearing Aid Self Fitting AppThe Investigational Medical Device (IMD) consists of the RH210 hearing aid software self-test function accessed through the Rehear smartphone application and used in combination with the RH210A compatible in-ear hardware platform. For this clinical investigation, the RH210A hardware platform is used to present calibrated test sounds (pure tones) to the participant during the app-based self-test. The RH210A is not being evaluated as a diagnostic audiometer, and the study is not designed to evaluate the hearing aid's amplification performance. The two RH210 self-test response methods evaluated in this study are: * Detection response method: the participant presses the response control when they hear the tone or beep (Mode A). * Audibility-release response method: the participant maintains the response control while the tone or beep is audible and releases the response control when they no longer hear the tone or beep (Mode B). | Device | Mode A, Mode B |
| AudiometryThe comparator for this clinical investigation is conventional manual pure-tone audiometry performed in accordance with ANSI/ASA S3.21-2004 (R2023), Methods for Manual Pure-Tone Threshold Audiometry, followed by generation of a NAL-R-based prescribed gain output. | Procedure or surgery | Conventional manual pure-tone audiometry |
Primary outcome
Agreement of NAL-R prescribed gain outputs (dB) between the comparator conditions
Time frame: Day 1
The primary endpoint is the agreement of NAL-R prescribed gain outputs (dB), by ear (R/L) and frequency (Hz), between: * Conventional-audiometry-derived NAL-R prescribed gain (dB), and * RH210 self-test-derived NAL-R prescribed gain (dB), generated using each of the two RH210 response methods. The frequency-specific analysis will include: 500 Hz; 1 kHz; 2 kHz; and 4 kHz. The two RH210 response methods are: * Detection response method: participant presses when they hear the tone or beep (Mode A). * Audibility-release response method: participant releases the response control when they no longer hear the tone or beep Mode B).
2 secondary outcomes
Difference in Speech Intelligibility Index (SII) and SRT in quiet (CNC words) between the three conditions
Time frame: Day 1
Number of Participants with Treatment-Related Adverse Events as classified by ISO14155:2026
Time frame: Day 1
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 3 Aug 2026.
- Individual participant dataSharing planned: No. The study is a commercial sponsor investigation of a product that is not yet cleared by regulatory agencies
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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 OTC Hearing Aid Self Fitting App and Audiometry in people with Sensorineural Hearing Loss 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 16 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: opening soon, as of the sponsor's last update on 3 Aug 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?
Agreement of NAL-R prescribed gain outputs (dB) between the comparator conditions (time frame: Day 1). 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 3 Aug 2026.