Quality Control of CE-Certified Phonak Hearing Aids - 2018_07
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sonova AG
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Visibility and Wearing Comfort
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, functions and wearing comfort. 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 or 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
- •willingness to wear custom made Hearing aids
- •Informed Consent as documented by signature
- •Benefit with TFG tool at least on one ear
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
- •Limited dexterity (not able to change a 10size Hearing aid battery)
- •no Benefit of the TFG tool on both ears
- •Known psychological problems
- •Central hearing disorders
研究组 & 干预措施
Device: Extension of Phonak Virto B-Titanium
The extension of Phonak Virto B-Titanium will be fitted to the participants individual Hearing loss.
干预措施: Extension of Virto B-Titanium (Device)
Device: Phonak Virto B-Titanium
The Phonak Virto B-Titanium will be fitted to the participants individual Hearing loss.
干预措施: Virto B-Titanium (Device)
结局指标
主要结局
Visibility and Wearing Comfort
时间窗: 3 weeks
The primary objective of this study is to evaluate if Virto B-Titanium hearing aids measured with the Titanium FitGuide (TFG) (extension of Virto B-Titanium) are less visible (deeper) than modeling without TFG (Virto B-Titanium) while maintaining wearing comfort on adult participants (new and existing users) with mild to moderately-severe hearing loss (M and P receiver ).
次要结局
- Measurement of acoustic Feedback Thresholds(3 weeks)