Device Clinical Trial of the Efficacy of Using Novel Remote Self-fitting Software Compared With Standard Remote Fitting Software in the Customisation of Hearing-aid Settings for Adults With Hearing Loss
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sonova AG
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Change in speech perception after 30 days
研究概览
简要总结
The purpose of the study is to evaluate the efficacy of a prototype app for the self-fitting of hearing aids.
详细描述
After being informed about the study and potential risks, clients giving written informed consent will be enrolled as participants. Each participant will use the app to self-fit and fine-tune the study aids over 30 days. Outcome measures include speech perception tests, questionnaires and the need for support with using the app. Own-aid performance is the reference, while unaided performance is the baseline.
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
- 是
入选标准
- •Online client
- •Daily aid use
- •Bilateral aid use
- •Uses P70-R or P90-R aids (same model both ears)
- •Does not use earmolds
- •Uses same soft tip on both aids
- •Owns iPhone7/iOS12 or later
- •Willing to install prototype app on own phone and use it in study
- •Willing to participate in study for 30 days
排除标准
- •Dexterity or cognitive issues that would be problematic for using the app in the study
研究组 & 干预措施
Experimental phone app
Experimental phone app for self-fitting of hearing aids
干预措施: Experimental phone app used for self-fitting of hearing aids (Device)
结局指标
主要结局
Change in speech perception after 30 days
时间窗: Day 1 and Day 30
The online Speech Perception Test developed by Blamey Saunders Hearing will be used to assess the effect of the intervention on speech perception.
Change in self-rated hearing ability after 30 days
时间窗: Day 1 and Day 30
An expanded version of the Client Oriented Scale of Improvement questionnaire will be used to assess the effect of the intervention on self-rated hearing ability in different listening situations.
Softest sounds that can be heard
时间窗: Day 1
The intervention will be used to measure the softest sounds that can be heard at different tone frequencies.
次要结局
- Change in preferences for fitted settings and fitting method over 30 days(Day 1, Day 10, Day 20 and Day 30.)
- Change in experimental self-fitting phone app use over 30 days(Days 1-30)