Quality Control of CE-Certified Phonak Hearing Aids - 2020_26
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sonova AG
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Rating of the sound quality for the new and the comparative HI
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 investigate the combination of the features to determine if the audiological performance and quality of the new successor of the Marvel family shows an improved benefit over Phonak Audéo Marvel before going into the System Validation. Therefore this study will be a comparative study. The study will determine if hearing impaired users wearing the successor hearing aids, have better initial acceptance with the new precalculation, better sound quality and speech intelligibility, more clarity and loudness comfort in soft and loud environments compared to Phonak Marvel RIC (Receiver in channel) hearing aids. Another objective of the study is to compare the listening effort with the two different study devices.
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
- •Hearing Loss range: N3-N4
- •experienced hearing aid user
- •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
- •first time user
- •limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
- •participant is not able to describe experiences and hearing impressions
- •allergies against the material of the hearing aid
研究组 & 干预措施
Successor of Phonak Audéo M-90
Phonak Hearing instrument (HI) with modified precalculation.
干预措施: RIC (Receiver in Canal) hearing aid/ hearing instrument (HI) (Device)
Phonak Audéo M-90
Phonak Audéo M-90 is the most recent RIC device from Phonak which will be fitted to the participants individual hearing loss.
干预措施: RIC (Receiver in Canal) hearing aid/ hearing instrument (HI) (Device)
结局指标
主要结局
Rating of the sound quality for the new and the comparative HI
时间窗: 4 weeks
Subjective rating of the overall satisfaction for sound quality by questionnaires for the new HI and the old comparative HI (%). The participants rates after one week home trial. The home trial is randomized. The questionnaire includes rating scales for the satisfaction. The participant has to rate it in percentage (100% = very satisfy, 0% = very unsatisfy)
次要结局
- Rating of sound quality(1 week)
- Speech intelligibility in noisy situations (only test device)(4 week)
- Speech intelligibility in quiet situations(4 week)
- Speech intelligibility in noisy situations(4 weeks)