An interventional study of OTC Hearing Aid Self Fitting App and Audiometry in Sensorineural Hearing Loss, Perceived Hearing Loss and Hearing Impairment, sponsored by Rehear Audiology Company LTD. Not yet recruiting at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by Rehear Audiology Company LTD · Not applicable, Interventional, and Treatment
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:
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.
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:
The study is designed to:
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.
346 studies on the registry are indexed under Hearing Loss, Sensorineural; 100 are open to participants now.
This study's planned enrollment of 24 is below the median of 32 across 247 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.
Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria:
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Conventional manual pure-tone audiometry
Procedure: Audiometry
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
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).
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.
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).
Time frame: Day 1
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
Time frame: 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.
Time frame: Day 1
Participant preference (A vs B questionnaire) will be assessed after completion of both self fit response methods.
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.
Time frame: Day 1
Compare the practical performance of the two RH210 self-test response methods using NAL checklist.
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.
Time frame: Day 1
Plan to share: No — The study is a commercial sponsor investigation of a product that is not yet cleared by regulatory agencies
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Rehear Audiology Company LTD