Evaluation and Optimization of Hearing Devices in 3-D Complex Audio Environments Study 3
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sonova AG
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Success rate of the distance discrimination
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 assess strengths 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 the University Hospital of Zürich.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants fulfilling any of the following inclusion criteria are eligible for the study:
- •Adult persons (minimum age: 18 years)
- •Healthy outer ear (without previous surgical procedures, except cochlear implantation)
- •Ability to fill in a questionnaire conscientiously
- •Informed Consent as documented by signature
- •Normal hearing participants
- •Adult persons with audiometric normal hearing thresholds
- •Hearing impaired participants
- •Adult hearing impaired persons with and without (experience with) hearing aids
- •Adult hearing impaired persons with cochlear implant(s)
- •The presence of any one of the following
排除标准
- •will lead to exclusion of the participant:
- •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
研究组 & 干预措施
Experimental: normal-hearing and hearing-impaired participants
normal and hearing-impaired participants
干预措施: Effect of several processing on the auditory distance perception (Procedure)
结局指标
主要结局
Success rate of the distance discrimination
时间窗: 8 weeks
Participants are asked whether an audio stimulus is closer or further at the end of the stimulus than at its beginning. The success rate is measured as a function of the test conditions.
次要结局
未报告次要终点