Clinical Evaluation of the Nuance Audio Hearing Aid in Adults With Mild to Moderate Hearing Difficulties
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Speech intellegibility testing (Matrix test) with and without device
研究概览
简要总结
The research will produce clinical effectiveness performance metrics using standardised procedures of the Nuance Audio hearing device.
详细描述
EssilorLuxottica is actively pursuing commercialization of their Nuance Audio device in the US (Class 2 - OTC SaMD) and in the EU under the Class IIa classification for hearing aids. The device form factor is an eyeglass frame. Currently there are no medical devices marketed as a hearing aid in the intended form factor (Nuance Audio) which suggests the need for preclinical and clinical evaluations to assess any impact to non-clinical standards compliance and user clinical performance. The manufacturer is actively addressing standards compliance with qualified third-party laboratories and has engaged NAL to collaborate on the clinical assessments based on its extensive history and expertise in the personal hearing aid arena.
Clinical assessment of device performance (basic safety and effectiveness with intended users) will be conducted as per study protocol. Additionally, to ensure quality, preliminary bench top compliance testing will be conducted as part of the study prior to first participant enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Native English speakers
- •Self-reported hearing or listening difficulties
- •No need for prescription lenses (contact lenses acceptable)
- •Ability to use smartphones and complete online surveys
- •Willingness and ability to attend two in-person research appointments
排除标准
- •Active ear disease, occluding cerumen, or any of the FDA "red flag" conditions
- •Hearing asymmetry or sudden hearing changes
- •Requirement for prescription eyewear (due to device form factor)
研究组 & 干预措施
Clinical performance speech intelligibility with Hearing aid in spectacle frame form factor
This study uses a within-subjects design in which participants complete assessments in both unaided and aided conditions, using the Nuance Audio Glasses as the investigational hearing aid device. Each participant attends two sessions at the National Acoustic Laboratories (NAL), with testing conducted in controlled and real-world environments.
Research methods include:
Audiometric assessments: Pure-tone audiometry, tympanometry, and Real Ear Measurements (REMs).
Speech perception testing: Conducted in both quiet and noise using validated Australian English BKB sentence materials.
Real-world assessments: Moderated walking tour in various acoustic settings (e.g., quiet rooms, traffic noise, multi-talker babble).
Self-reported measures: Questionnaires assessing hearing difficulty (HHIE-S), listening goals (COSI), perceived benefit (IOI-HA), and device preference and satisfaction.
干预措施: Hearing aid in spectacle frame form factor (Device)
Clinical performance speech intelligibility with Hearing aid in spectacle frame form factor
This study uses a within-subjects design in which participants complete assessments in both unaided and aided conditions, using the Nuance Audio Glasses as the investigational hearing aid device. Each participant attends two sessions at the National Acoustic Laboratories (NAL), with testing conducted in controlled and real-world environments.
Research methods include:
Audiometric assessments: Pure-tone audiometry, tympanometry, and Real Ear Measurements (REMs).
Speech perception testing: Conducted in both quiet and noise using validated Australian English BKB sentence materials.
Real-world assessments: Moderated walking tour in various acoustic settings (e.g., quiet rooms, traffic noise, multi-talker babble).
Self-reported measures: Questionnaires assessing hearing difficulty (HHIE-S), listening goals (COSI), perceived benefit (IOI-HA), and device preference and satisfaction.
干预措施: hearing aid (Device)
结局指标
主要结局
Speech intellegibility testing (Matrix test) with and without device
时间窗: Day 1
Conducted in both quiet and noise using validated Australian English BKB sentence materials.
次要结局
- Real-world assessments(day 1)