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
- 20
- 试验地点
- 2
- 主要终点
- Speech Intelligibility in Noise
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. These sound changing principles are enabled by respective 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 randomized active comparator clinical evaluation which will be conducted mono-centric at Sonova AG Headquarter based in Staefa.
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)
盲法说明
The participant's will not know which intervention will be applied.
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) with and without experience with) hearing aids
- •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 medical device 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
研究组 & 干预措施
Sound Processing Principle 1
Sound Processing Principle 1 will be applied in the hearing aid.
干预措施: Phonak Audéo L2M with Sound Processing Principle 1 (Device)
Sound Processing Principle 2
Sound Processing Principle 2 will be applied in the hearing aid.
干预措施: Phonak Audéo L2M with Sound Processing Principle 2 (Device)
Sound Processing Principle 3
Sound Processing Principle 3 will be applied in the hearing aid.
干预措施: Phonak Audéo L2M with Sound Processing Principle 3 (Device)
结局指标
主要结局
Speech Intelligibility in Noise
时间窗: 4 weeks
The speech intelligibility in noise with the three different sound processing principles will be assessed with the aid of the Oldenburg Sentence Test. The result will be shown in dB (decibel) SRT (Speech Reception Threshold).
次要结局
- Clarity - Daily Life(16 weeks)
- Localization - Daily Life(16 weeks)
- Sound Quality - Overall(16 weeks)
- Loudness - Laboratory(8 weeks)
- Loudness - Daily Life(16 weeks)
- Preferred Sound Processing Principle(16 weeks)
- Naturalness - Daily Life(16 weeks)
- Reverberation - Daily Life(16 weeks)
- Satisfaction - Overall in Daily Life(16 weeks)