Clinical Evaluation of Hearing Aid OTC Self-Assessment Methods for Adults With Perceived Mild-to-Moderate Hearing Loss
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.
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.
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Studientyp
Einschreibung (Geschätzt)
Einschreibung
Phase
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
Studienkontakt
- Name: Marisa Poulos, Master of Audiology
- Telefonnummer: +61 2 9412 6872
- E-Mail: marisa.poulos@nal.gov.au
Studieren Sie die Kontaktsicherung
- Name: Sanna Hou, Master of Audiology
- Telefonnummer: +61 2 9412 6872
- E-Mail: sann.hou@nal.gov.au
Studienorte
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New South Wales
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Macquarie Park, New South Wales, Australien, 2113
- National Acoustic Laboratories
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Kontakt:
- Bettina Turnbull, AuD
- Telefonnummer: +61 2 9412 6872
- E-Mail: Bettina.Turnbull@nal.gov.au
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Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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:
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Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
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Aktiver Komparator: Conventional manual pure-tone audiometry
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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.
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Experimental: Mode A
RH210 self-test method 1: detection response method, where the participant presses when they hear the tone or beep
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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:
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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
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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:
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Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Agreement of NAL-R prescribed gain outputs (dB) between the comparator conditions
Zeitfenster: Day 1
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The primary endpoint is the agreement of NAL-R prescribed gain outputs (dB), by ear (R/L) and frequency (Hz), between:
The frequency-specific analysis will include: 500 Hz; 1 kHz; 2 kHz; and 4 kHz. The two RH210 response methods are:
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Day 1
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Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Number of Participants with Treatment-Related Adverse Events as classified by ISO14155:2026
Zeitfenster: Day 1
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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:
No formal statistical hypothesis is proposed for safety. Safety outcomes will be summarized descriptively. |
Day 1
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Difference in Speech Intelligibility Index (SII) and SRT in quiet (CNC words) between the three conditions
Zeitfenster: Day 1
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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
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Andere Ergebnismessungen
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Participant preference (A vs B questionnaire) will be assessed after completion of both self fit response methods.
Zeitfenster: Day 1
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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:
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Day 1
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Compare the practical performance of the two RH210 self-test response methods using NAL checklist.
Zeitfenster: Day 1
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Exploratory endpoints will include, for each response method:
No formal hypothesis is proposed. Results will be summarized descriptively. |
Day 1
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Mitarbeiter und Ermittler
Sponsor
Sponsor
Mitarbeiter
Mitarbeiter
Ermittler
Ermittler
- Hauptermittler: Bettina Turnbull, Doctor of Audiology, National Acoustic Laboratories
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Studienbeginn
Primärer Abschluss (Geschätzt)
Primärer Abschluss
Studienabschluss (Geschätzt)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Neurologische Manifestationen
- Erkrankungen des Nervensystems
- Otorhinolaryngologische Erkrankungen
- Empfindungsstörungen
- Ohrenkrankheiten
- Hörstörungen
- Pathologische Zustände, Anzeichen und Symptome
- Anzeichen und Symptome
- Schwerhörigkeit
- Hörverlust, sensorineural
- Muskuloskelettaler und neuronales physiologisches Phänomen
- Physiologische Phänomene
- Physiologische Phänomene des Nervensystems
- Sensation
- Vestibulocochlear physiologische Phänomene
- Anhörung
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- NAL C26.08
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
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