Clinical Evaluation of a Cochlear Implant System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cochlear
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Cochlear implant subjects' ratings on hearing performance, connectivity, streaming, phone use, comfort, retention, ease of use and controls obtained with their own Sound Processor and the CP1000 Sound Processor.
研究概览
简要总结
The primary objective of this study is to assess the usability of a Cochlear implant system.
详细描述
Measure participant ratings on satisfaction of a Cochlear implant system via use of validated and non-validated questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eighteen years of age or older
- •At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear
- •At least 3 months experience with the CP810,CP920 or CP910 sound processor
- •Fluent speaker in the language used to assess speech perception performance
- •Willingness to participate in and to comply with all requirements of the protocol
- •Able to score 30% or more at +15 SNR with CI alone on a sentence in babble test
排除标准
- •Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device
- •Additional disabilities that would prevent participation in evaluations
- •Nucleus 22 Implant
研究组 & 干预措施
Cochlear implant users
This is a within-subject, repeated measures study. There was one arm in this study, each subject served as their own control. All subjects received all interventions.
干预措施: Nucleus 7 Cochlear Implant System (Device)
结局指标
主要结局
Cochlear implant subjects' ratings on hearing performance, connectivity, streaming, phone use, comfort, retention, ease of use and controls obtained with their own Sound Processor and the CP1000 Sound Processor.
时间窗: One year
Non-inferiority of subjects' overall satisfaction ratings for the CP1000 Sound Processor and related components measured following 3 months of use, compared to subjects' overall satisfaction rating for their own Sound Processor and related components measured at study onset.
次要结局
- Speech perception performance of the CP1000 Sound Processor in quiet and in noise.(One year)