Quality Control of CE-Certified Phonak Hearing Aids - 2019_34
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sonova AG
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Rating of the subjective comfort for the old and the new setting
研究概览
简要总结
Phonak Hearing Devices pass through different development and study phases. At an early stage, feasibility 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 interdependency 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 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 compare two settings of an external microphone under real life conditions with experienced hearing aid users.
The external microphone streams the signal (e.g. speaker) directly into the hearing instrument (HI).
The subject should rate the devices in the lab and after a hometrial. The comfort, regarding to the loudness and the sound quality will be tested with the two settings at home and in the lab. Also the speech intelligibility will be tested in the lab.
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
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •experienced hearing aid user
- •severe hearing loss
- •willingness and interest in testing an external microphone healthy outer ear
- •willingness to wear behind the ear hearing aids
- •Informed Consent as documented by signature
排除标准
- •the audiogram 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
Rating of the subjective comfort for the old and the new setting
时间窗: 6 weeks
Rating of the comfort, regarding to the loudness, with the old and the new setting of the external microphone (%)
次要结局
- Evaluation of the speech intelligibility in noise(2 weeks)
- Subjective rating of natural sounds(6 weeks)
- Subjective Sound Quality rating(6 weeks)