Clinical Evaluation of the SpatialNR Noise Reduction Algorithm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cochlear
- 入组人数
- 48
- 试验地点
- 4
- 主要终点
- CNC words
研究概览
简要总结
Acute in-booth assessment of a new noise reduction algorithm with cochlear implant recipients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Conventional CI subject aged twelve years of age or older, or Hybrid subject aged 18 years or older
- •Recipient of a CI500 Series (CI512 or CI522) or CI24RE Series (CI24REH or CI422) cochlear implant
- •At least three months CI experience in ear to be assessed
- •At least three months experience with the CP810,CP920 or CP910 sound processor
- •Fluent speaker in the local language used to assess clinical performance
- •Open-set speech perception ability
- •Use of or eligibility for hybrid acoustic component (hybrid population only)
排除标准
- •Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the investigational device
- •Unwillingness or inability of the candidate to comply with all investigational requirements
- •Additional handicaps that would prevent or restrict participation in the audiological evaluations or that would affect the scientific integrity of the study.
研究组 & 干预措施
Conventional CI
The conventional CI group will receive the noise reduction on and off signal processing test programs. This is a within subject repeated measures design, so all subjects will receive the same testing but in a counterbalanced order.
干预措施: CP910/CP920 with noise reduction on (Device)
Conventional CI
The conventional CI group will receive the noise reduction on and off signal processing test programs. This is a within subject repeated measures design, so all subjects will receive the same testing but in a counterbalanced order.
干预措施: CP910/CP920 (Device)
Hybrid CI
The Hybrid CI group will receive the noise reduction on and off signal processing test programs. This is a within subject repeated measures design, so all subjects will receive the same testing but in a counterbalanced order.
干预措施: CP910/CP920 with noise reduction on (Device)
Hybrid CI
The Hybrid CI group will receive the noise reduction on and off signal processing test programs. This is a within subject repeated measures design, so all subjects will receive the same testing but in a counterbalanced order.
干预措施: CP910/CP920 (Device)
结局指标
主要结局
CNC words
时间窗: 3 months
CNC words in quiet will be used to assess whether the investigational noise reduction algorithm performs no worse than the approved Nucleus 6 defaults.
SRT sentences
时间窗: 3 months
SRT sentences in noise will be used to assess whether the investigational noise reduction algorithm performs no worse than the approved Nucleus 6 defaults.
次要结局
未报告次要终点