Quality Control of CE-Certified Phonak Hearing Aids - 2019_23
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Sonova AG
- 试验地点
- 2
- 主要终点
- Successful creation of a Custom Sceario (%)
研究概览
简要总结
Phonak Hearing Devices pass through different development and study phases. At an early stage, feasibiltiy studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interpendency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, resulting from the pre-validation studies, they get optimized. Prior to product launch, the Phonak Hearing Systems get reviewed by a final quality control in terms of clinical trials. This is a pre-validation study, investigating improved algorithms, features, functions and wearing comfort. This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).
详细描述
This study will prove the overall performance and system context of the functionality in the mobile application in combination with hearing devices under real life conditions with experienced hearing aid users. The enduser should be able to adjust their hearing aid settings by App.
The app allows the user to change e.g. the loudness of the hearing aids and to create hearing scenarios by themselves. The users also shall be able to accept a conferecene call, which they will receive from the investigator via App.
This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •experienced hearing aid users (minimum age: 18 years, moderate to moderate/severe hearing loss)
- •modern subjects with an affinity to new technology
- •willingness and interest in testing Apps
- •owning a compatible smartphone
- •Healthy outer ear
- •willingness to wear behind the ear hearing aids
- •Informed Consent as documented by signature
排除标准
- •the audiogramm is not in the fitting range of the intended hearing aid
- •limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
- •participant is not able to describe experiences and hearing impressions
结局指标
主要结局
Successful creation of a Custom Sceario (%)
时间窗: 4 weeks
Endusers of the phoneApp are able to add a custum scenario to the app.
Successful answering of conference call (%)
时间窗: 2 weeks
Endusers of the phoneApp are able to answering the conference call?
次要结局
未报告次要终点