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Clinical Evaluation of the RH210 Hearing Aid

26 mei 2026 bijgewerkt door: Rehear Audiology Company LTD

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

24

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

  • Naam: Sanna Hou, Master of Audiology
  • Telefoonnummer: +61 2 9412 6872
  • E-mail: sann.hou@nal.gov.au

Studie Locaties

  • Australië
    • New South Wales
      • Macquarie Park, New South Wales, Australië
        • Werving
        • National Acoustic Laboratories
        • Contact:
        • Hoofdonderzoeker:
          • Bettina Turnbull, AuD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: All participants
Trial device assessment in first appointment, comparator in second appointment
Apparaat: Investigational device (RH210A)
Over the counter device
Apparaat: Apple AirPods Pro (2nd Generation) with Hearing Aid Feature (HAF)
FDA cleared OTC device (Control arm)
Ander: All Participants
Comparator in appointment one, trial device in appointment 2
Apparaat: Investigational device (RH210A)
Over the counter device
Apparaat: Apple AirPods Pro (2nd Generation) with Hearing Aid Feature (HAF)
FDA cleared OTC device (Control arm)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Aided vs unaided pure-tone audiogram (PTA) measured in dBSPL
Tijdsspanne: 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.
Day 1 (Visit 1) and Day 7 (Visit 2)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Speech understanding in background noise (BKB-SIN; AUS)
Tijdsspanne: Day 1 (Visit 1) and Day 7 (Visit 2)

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.
Day 1 (Visit 1) and Day 7 (Visit 2)
Real Ear Measure Measurement (REIG)
Tijdsspanne: Day 1 (Visit 1) and Day 7 (Visit 2)
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.
Day 1 (Visit 1) and Day 7 (Visit 2)
Moderated walk to evaluate simulated "real world benefit" (Ecological Momentary Assessment (EMA): NAL Australia).
Tijdsspanne: Day 1 (Visit 1) and Day 7 (Visit 2)

Participants will use the to use the devices in a controlled, moderated, 60 minute walk. The walk will cover five key listening environments and :

  1. Library (~40 dBA) very low or no noise
  2. Office (~50 dBA) with low level noise
  3. Outdoor parkway (~55 dBA) with environmental noise
  4. Traffic / street (~70-75 dBA) with traffic noise
  5. 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.
Day 1 (Visit 1) and Day 7 (Visit 2)

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Usability of RH210 using the System Usability Survey (SUS: NAL)
Tijdsspanne: Day 1 (Visit 1) and Day 7 (Visit 2)

Assess the subjective usability of the RH210 hearing aid software and application workflow in real-world use using the System Usability Survey (SUS) from the National Acoustic Laboratory (NAL). This is to gather data for a proposed human factors evaluation.

The scoring is

  • Poor: Scores below 51 are considered poor.
  • Average Score: 68.
  • Above Average: > 68.
  • Below Average: < 68.
  • Good/Excellent: Scores over 79 are considered good, while 80.3 or higher is an A grade.
Day 1 (Visit 1) and Day 7 (Visit 2)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Rehear Audiology Company LTD

Medewerkers

Global Edge Medtech Consulting
National Acoustic Laboratories

Onderzoekers

  • Hoofdonderzoeker: Bettina Turnbull, Doctor of Audiology, National Acoustic Laboratories

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

11 april 2026

Primaire voltooiing (Geschat)

30 juli 2026

Studie voltooiing (Geschat)

30 augustus 2026

Studieregistratiedata

Eerst ingediend

16 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

30 april 2026

Eerst geplaatst (Werkelijk)

7 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

26 mei 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • NAL C26.02

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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