Investigation of the Naída CI M90 Sound Processor in Various Acoustic Scenarios
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Difference in speech perception in noise with AutoSense OS on Naída M hearing devices and AutoSound OS on the clinically available Naída Q hearing devices
研究概览
简要总结
In this clinical trial, an un-controlled, repeated measures open design with within-subject comparison will be used to evaluate the effect of Naída Link M90 hearing aid and Naída CI M90 sound processor on sound perception. This design was shown to be successful in previous studies for the evaluation of sound coding strategies. Furthermore, a within-subject comparison decreases the variance in the results allowing for fewer subjects when the population that uses the investigational device is not large in general.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •CI users with a CII, HiRes90K (Advantage) or HiRes Ultra implant system
- •Bilateral users: two implant systems
- •Bimodal users: hearing aid contralateral
- •Minimum of 18 years of age
- •Minimum of six months experience with their implant system
- •Minimum of six months experience with the Naída CI Q-Series sound processor
- •Ability to give feedback on sound quality
- •Speech intelligibility with the HSM sentence test in noise at 10 dB SNR > 10% as obtained during previous visits in the clinical routine
- •Fluent in German language
排除标准
- •Difficulties additional to hearing impairment that would interfere with the study procedures
- •Concurrent participation in other study
- •Pregnant and breast-feeding women
结局指标
主要结局
Difference in speech perception in noise with AutoSense OS on Naída M hearing devices and AutoSound OS on the clinically available Naída Q hearing devices
时间窗: 6 weeks
Difference in speech reception threshold of 50% speech understanding which is the signal to noise ratio in Decibel \[dB\] to understand 50% of the target speech between AutoSense OS on Naída M hearing devices and AutoSound OS on the clinically available Naída Q hearing devices.
次要结局
- Differences in speech perception in noise threshold measured in Decibel [dB](6 weeks)
- Differences in speech understanding in noise measured in % correct(6 weeks)
- Differences in music enjoyment ratings measured in rating score(6 weeks)
- Differences in speech perception in quiet threshold measured in Decibel [dB](6 weeks)
- Differences in mono/stereo identification measured in % correct(6 weeks)