Quality Control of CE-Labelled Phonak Hearing Systems (Study Part: Sonova2015-00)
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
- 2
- 主要终点
- Speech intelligibility in quiet. Discrimination [%]
研究概览
简要总结
The purpose of this study, which contains a series of successive study parts, is to methodically evaluate Phonak Hearing Systems on hard of hearing participants to grant quality control prior to each product launch.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Hearing impaired persons with and without (experience with) hearing aids
- •Good written and spoken (Swiss) German language skills
- •Healthy outer ear (without previous surgical procedures)
- •Ability to fill in a questionnaire conscientiously
- •Informed Consent as documented by signature
排除标准
- •Contraindications to the medical device in this study, e.g. known hypersensitivity or allergy to the investigational product
- •Limited mobility and not in the position to attend weekly appointments
- •Limited ability to describe listening impressions/experiences and the use of the hearing aid
- •Inability to produce a reliable hearing test result
- •Massively limited dexterity
- •Known psychological problems
- •Central hearing disorders
结局指标
主要结局
Speech intelligibility in quiet. Discrimination [%]
时间窗: One week.
The data, serving as primary outcome, are collected in a series of lab appointments. The speech intelligibility in quiet will be assessed with the aid of the German rhyme test "Einsilber-Reimtest nach von Wallenberg und Kollmeier" (WaKo). The result is the speech intelligibility in percent. Descriptive statistics will be executed in the form of determining the median and quartiles. Interference statistics will be executed by applying the appropriate parametric or non-parametric test, depending on the data's distribution. A significance level of 5% is pursued.
Speech intelligibility in noise. Speech Reception Threshold [dB SNR]
时间窗: One week.
The data, serving as primary outcome, are collected in a series of lab appointments. The speech intelligibility in noise will be assessed with the aid of the German Oldenburger sentence test. The result is the Speech Reception Threshold \[dB SNR\]. Descriptive statistics will be executed in the form of determining the median and quartiles. Interference statistics will be executed by applying the appropriate parametric or non-parametric test, depending on the data's distribution. A significance level of 5% is pursued.
次要结局
- Phoneme Perception Test, test no. 2.(Four weeks)
- Phoneme Perception Test, test no. 3.(Four weeks)
- Diary to describe hearing impressions in everyday life(Six weeks)
- Phoneme Perception Test, test no. 1.(Four weeks)