Quality Control of CE-Certified Phonak Hearing Aids - 2020_43
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sonova AG
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Subjective Listening Effort Scaling
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 investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).
详细描述
The study will compare different features of the Phonak behind the ear device activated and deactivated, for example the noise reduction feature. There shall be differences in listening effort, awareness and sound quality shown. The study shall show the advantages especially for people with severe to profound hearing losses. 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 99 Years（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, severe to profound Hearing loss)
- •Good written and spoken (Swiss) German language skills
- •Healthy outer ear
- •Ability to fill in a questionnaire (p/eCRF) conscientiously
- •willingness to wear Behind-the-ear hearing aids
- •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
- •Known psychological problems
结局指标
主要结局
Subjective Listening Effort Scaling
时间窗: 2 weeks
A listening effort scaling procedure ('ACALES'; Krueger et al, 2017) was performed with noise cancellation on and off. ACALES is adaptive, altering the signal-to-noise ratio (SNR) at which speech is presented. Therefore it is not a simple rating scale. For each stimulus, a rating (14-point scale ranging from 1='effortless' to 14= 'only noise') was given for how "effortful" it was following speech. This results in 2-D data: a list of presentation SNRs (different for each participant), and respective participant ratings. Given the format of this data, it cannot be summarized using standard descriptive statistics. We defined SNR as the dependent variable and fitted a linear mixed effects model, with the predictors: listening effort rating \& intervention (treating participants as a random factor), characterizing SNR over the entire rating scale. The values reported represent the estimated marginal means of SNR for each intervention, averaged across effort ratings \& participants.
次要结局
- Measure of Detection Threshold (in dB) for Soft Sounds(2 weeks)
- Subjective Ratings of Speech and Music Samples (Part 2: Artefact Perception)(2 week)
- Subjective Ratings of Speech and Music Samples (Part1: Sound Quality)(4 weeks)