Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sonova AG
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- sound quality ratings
研究概览
简要总结
A methodical evaluation of novel sound changing principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. These sound changing principles are enabled by respective hearing instrument technologies and hearing instrument algorithms. The aim of the study is to investigate and asses strength and weaknesses of these novel sound changing principles in terms of hearing performance to determine their application in hearing instruments (Phase of development). Both, objective laboratory measurements as well as subjective evaluations in real life environment will be carried out. This will be a controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarter based in Stäfa
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy outer ear (without previous surgical procedures)
- •Ability to fill in a questionnaire 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
- •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
- •Known central hearing disorders
- •colour blinded
研究组 & 干预措施
Hearing Aid standard NR_1
Hearing Aid with standard Noise Reduction (NR) serves as reference condition.
干预措施: Hearing Aid with standard Noise Reduction (NR_1) (Device)
Hearing Aid with NR_2
NR_2: Noise Reduction principle 2
干预措施: Hearing Aid with NR_2 (Device)
Hearing Aid with NR_3
NR_3: Noise Reduction principle 3
干预措施: Hearing Aid with NR_3 (Device)
Hearing Aid with NR_4
NR_4: Noise Reduction principle 4
干预措施: Hearing Aid with NR_4 (Drug)
结局指标
主要结局
sound quality ratings
时间窗: 4 weeks
The sound quality ratings will be assessed with the aid of a Multi-Stimulus Test. The data, serving as the primary outcome measure, are collected in the laboratory and will use a continuous rating scale. The scale ranges from 0 "very bad" to 100 "very good" in increments of 1.
次要结局
- Oldenburg sentence test & reaction time task(3 weeks)
- Oldenburg Sentence test (Olsa)(4 weeks)
- Adaptive Categorial Listening Effort Scaling (ACALES)(3 weeks)
- qualitative interview form(3 weeks)