Clinical Evaluation of the RH210 Hearing Aid
Clinical Evaluation of the RH210 Hearing Aid Software Used With RH210A Device in Adults With Perceived Mild-to-Moderate Hearing Loss
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Marisa Poulos, Master of Audiology
- Número de teléfono: +61 2 9412 6872
- Correo electrónico: marisa.poulos@nal.gov.au
Copia de seguridad de contactos de estudio
- Nombre: Sanna Hou, Master of Audiology
- Número de teléfono: +61 2 9412 6872
- Correo electrónico: sann.hou@nal.gov.au
Ubicaciones de estudio
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New South Wales
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Macquarie Park, New South Wales, Australia
- Reclutamiento
- National Acoustic Laboratories
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Contacto:
- Bettina Turnbull, AuD
- Correo electrónico: Bettina.Turnbull@nal.gov.au
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Investigador principal:
- Bettina Turnbull, AuD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: All participants
Trial device assessment in first appointment, comparator in second appointment
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Over the counter device
FDA cleared OTC device (Control arm)
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Otro: All Participants
Comparator in appointment one, trial device in appointment 2
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Over the counter device
FDA cleared OTC device (Control arm)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Aided vs unaided pure-tone audiogram (PTA) measured in dBSPL
Periodo de tiempo: Day 1 (Visit 1) and Day 7 (Visit 2)
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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.
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Day 1 (Visit 1) and Day 7 (Visit 2)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Speech understanding in background noise (BKB-SIN; AUS)
Periodo de tiempo: Day 1 (Visit 1) and Day 7 (Visit 2)
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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)
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Real Ear Measure Measurement (REIG)
Periodo de tiempo: Day 1 (Visit 1) and Day 7 (Visit 2)
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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.
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Day 1 (Visit 1) and Day 7 (Visit 2)
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Moderated walk to evaluate simulated "real world benefit" (Ecological Momentary Assessment (EMA): NAL Australia).
Periodo de tiempo: Day 1 (Visit 1) and Day 7 (Visit 2)
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Participants will use the to use the devices in a controlled, moderated, 60 minute walk. The walk will cover five key listening environments and :
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Day 1 (Visit 1) and Day 7 (Visit 2)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Usability of RH210 using the System Usability Survey (SUS: NAL)
Periodo de tiempo: Day 1 (Visit 1) and Day 7 (Visit 2)
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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
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Day 1 (Visit 1) and Day 7 (Visit 2)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Bettina Turnbull, Doctor of Audiology, National Acoustic Laboratories
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NAL C26.02
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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