Quality Control of CE-Certified Phonak Hearing Aids
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sonova AG
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Speech intelligibility in percent in a quiet listening situation
研究概览
简要总结
Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Adult hearing impaired persons (minimum age: 18 years) with and without (experience with) hearing aids
- •Good written and spoken (Swiss) German language skills
- •Healthy outer ear
- •Ability to fill in a questionnaire (p/eCRF) conscientiously
- •Informed Consent as documented by signature
排除标准
- •Contraindications to the MD 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
研究组 & 干预措施
Phonak Audéo V90-13
The Phonak Audéo V90-13 will be fitted to the participants individual hearing loss.
干预措施: Hearing Aid (Phonak Audéo V90-13) (Device)
Successor of Phonak Audéo V90-13
The successor of Phonak Audéo V90-13 will be fitted to the participants individual hearing loss.
干预措施: Hearing Aid (Successor of Phonak Audéo V90-13) (Device)
结局指标
主要结局
Speech intelligibility in percent in a quiet listening situation
时间窗: One week
The data, serving as primary outcomes 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.
次要结局
- Speech intelligibility in percent in a noisy listening situation(One week)