Clinical Evaluation of Hearing Aid OTC Self-Assessment Methods for Adults With Perceived Mild-to-Moderate Hearing Loss

July 30, 2026 updated by: Rehear Audiology Company LTD

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:

  1. To evaluate agreement between prescribed gain outputs generated from conventional audiometry and those generated from the self-assessment response method.
  2. Determine whether either self-assessment response method provides acceptable estimated audibility.
  3. 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

  1. Detection response method (Option 1): the participant presses a response control when they hear the tone or beep.
  2. 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:

  1. 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.
  2. Compare the detection response method and audibility-release response method with respect to prescribed gain agreement by ear and frequency.
  3. Assess estimated audibility associated with the self-assessment-derived NAL-R prescriptions using Speech Intelligibility Index (SII) analysis.
  4. 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.
  5. Evaluate participant preference between the detection response method and the audibility-release response method.
  6. Assess general agreement, completeness, invalid-test rate, usability and response consistency for each self-assessment response method.
  7. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Sanna Hou, Master of Audiology
  • Phone Number: +61 2 9412 6872
  • Email: sann.hou@nal.gov.au

Study Locations

  • Australia
    • New South Wales
      • Macquarie Park, New South Wales, Australia, 2113

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Conventional manual pure-tone audiometry
Procedure: Audiometry
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.
Experimental: Mode A
RH210 self-test method 1: detection response method, where the participant presses when they hear the tone or beep
Device: OTC Hearing Aid Self Fitting App

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).
Experimental: Mode B
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
Device: OTC Hearing Aid Self Fitting App

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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Treatment-Related Adverse Events as classified by ISO14155:2026
Time Frame: Day 1

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.
Day 1
Difference in Speech Intelligibility Index (SII) and SRT in quiet (CNC words) between the three conditions
Time Frame: Day 1

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
Day 1

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Participant preference (A vs B questionnaire) will be assessed after completion of both self fit response methods.
Time Frame: Day 1

The first exploratory objective is to evaluate participant preference between the two RH210 self-test response methods.

Participant preference will be assessed after completion of both RH210 response methods. The endpoint will include:

  • proportion of participants preferring the detection response method;
  • proportion preferring the audibility-release response method;
  • proportion reporting no preference;
  • reasons for preference, where collected. No formal hypothesis is proposed. Results will be summarized descriptively.
Day 1
Compare the practical performance of the two RH210 self-test response methods using NAL checklist.
Time Frame: Day 1

Exploratory endpoints will include, for each response method:

  • completion rate;
  • invalid or unusable test rate;
  • missing frequency-specific data rate;
  • test duration;
  • participant-reported ease of use;
  • observed difficulty or need for clarification;
  • repeatability or response consistency, where repeat data are available.

No formal hypothesis is proposed. Results will be summarized descriptively.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rehear Audiology Company LTD

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Global Edge Medtech Consulting
National Acoustic Laboratories

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bettina Turnbull, Doctor of Audiology, National Acoustic Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NAL C26.08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study is a commercial sponsor investigation of a product that is not yet cleared by regulatory agencies

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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