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
Visão geral do estudo
Status
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Marisa Poulos, Master of Audiology
- Número de telefone: +61 2 9412 6872
- E-mail: marisa.poulos@nal.gov.au
Estude backup de contato
- Nome: Sanna Hou, Master of Audiology
- Número de telefone: +61 2 9412 6872
- E-mail: sann.hou@nal.gov.au
Locais de estudo
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New South Wales
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Macquarie Park, New South Wales, Austrália
- Recrutamento
- National Acoustic Laboratories
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Contato:
- Bettina Turnbull, AuD
- E-mail: Bettina.Turnbull@nal.gov.au
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Investigador principal:
- Bettina Turnbull, AuD
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Outro: 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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Outro: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Aided vs unaided pure-tone audiogram (PTA) measured in dBSPL
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Speech understanding in background noise (BKB-SIN; AUS)
Prazo: 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)
Prazo: 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).
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Usability of RH210 using the System Usability Survey (SUS: NAL)
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NAL C26.02
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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