Assessment of Novel Measurement and Fitting Methods to Determine Their Reliability, Validity and Application
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sonova AG
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Comparison of fitting method A versus B in regard to sound quality
研究概览
简要总结
A methodical evaluation of novel measurement and fitting methods for individualizing CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. The aim of the study is to investigate and asses strength and weaknesses of these novel measurement and fitting methods in terms of optimizing hearing performance and experience and/or usability of the hearing aids and accessories. Both laboratory measurements as well as evaluations in real life environments will be carried out. This will be a controlled and randomised active comparator clinical evaluation which will be conducted mono-centric at Sonova AG Headquarter based in Stäfa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Audéo B-Direct fitted with fitting method A
Traditional standard fitting method which do not include adjustments from the participants.
干预措施: Hearing aid: Phonak Audéo B90-Direct (Device)
Audéo B-Direct fitted with fitting method B
Alternative fitting method which includes additional adjustments from the participants.
干预措施: Hearing aid: Phonak Audéo B90-Direct (Device)
结局指标
主要结局
Comparison of fitting method A versus B in regard to sound quality
时间窗: 2 months
The number of subjects who prefer the hearing aid setting achieved with hearing aid fitting method A versus B will be measured in the lab with the aid of sounds presented via loudspeakers. This will be measured with the Multiple Stimuli with Hidden Reference and Anchor (MUSHRA) method.
次要结局
- Comparison of fitting method A versus B in regard to speech intelligibility in noise(2 months)