Hearing Aid Transmitter Performance Study - SRF-366
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sonova AG
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Evaluation of speech intelligibility and sound quality for different loudspeaker
研究概览
简要总结
Sonova 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 Sonova Hearing Systems undergo a final quality control in terms of clinical trials. This is a confirmatory study, investigating benefits of a modified hearing aid loudspeaker. This will be a clinical investigation which will be conducted mono centric at National Acoustic Laboratories a well known institution with exceptional experience (Australia).
详细描述
In this study a comparison with two Phonak Receiver in Canal (RIC) devices is done. The experimental device with a modified hearing aid loudspeaker concept and the active comparator with the existing technology will be compared regarding speech intelligibility, listening effort and sound quality in speech in noise, quiet situations for people with mild to moderate hearing losses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 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, mild to moderate Hearing loss)
- •Good written and spoken English language skills
- •Healthy outer ear
- •Ability to fill in a questionnaire (p/eCRF) conscientiously
- •Willingness to wear Receiver in Canal hearing aids
- •Informed Consent as documented by signature
- •Normal cognitive abilities
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 Sydney (AUS)
- •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
Evaluation of speech intelligibility and sound quality for different loudspeaker
时间窗: 2 weeks
The Primary Outcome measure of this study is the comparison of the standard hearing aid loudspeaker with the modified one in regard to speech intelligibility in a noisy environment and sound quality in a quiet situation. The speech intelligibility will be measured using a speech test in dB SRT and the sound quality will be assessed by subjective rating, using percentage of satisfaction from "very satisfied (100)" to "very unsatisfied (0)".
次要结局
- Evaluation of sound quality of streamed signals for different loudspeaker(2 weeks)
- Evaluation of listening effort for different loudspeaker.(2 weeks)
- Evaluation of sound quality of own voice for different loudspeaker.(2 weeks)