Quality Control of CE-Certified Phonak Hearing Aids - 2017_37
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sonova AG
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Spontaneous acceptance of the initial pre-calculation (first fit)
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. 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, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials. This is a pre-validation study, investigating optimized algorithms, features and functions. This will be a clinical evaluation 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
- 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 at least 3 months 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 in Stäfa (Switzerland)
- •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
Successor of Phonak Audéo B-Direct
The successor of Phonak Audéo B-Direct will be fitted to the participants individual hearing loss.
干预措施: Successor of Phonak Audéo B-Direct (Device)
Phonak Audéo B-Direct
The Phonak Audéo B-Direct will be fitted to the participants individual hearing loss.
干预措施: Phonak Audéo B-Direct (Device)
结局指标
主要结局
Spontaneous acceptance of the initial pre-calculation (first fit)
时间窗: One week
The data, serving as primary outcomes are collected in the first study appointment. The spontaneous acceptance of the initial pre-calculation (also called 'first fit') in regard to loudness and sound quality will be assessed with the aid of a systematic interview in lab.
次要结局
- Listening effort in noisy listening environment(One week)
- Speech intelligibility in noisy listening environment(One week)