Investigation of Nucleus 6 Sound Processor Input Processing in Cochlear Implant Recipients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cochlear
- 入组人数
- 40
- 试验地点
- 8
- 主要终点
- Endpoint 1: Evaluation of Signal to Noise Ratio - Noise Reduction
研究概览
简要总结
The purpose of this study is to evaluate the enhanced signal processing features of the Nucleus 6 Sound Processor on existing Nucleus cochlear implant recipients currently using the Nucleus 5 Sound Processor.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Greater than 12 years
- •Unilateral cochlear implant recipient (CI24RE, CI500, CI422)
- •Minimum of 3 months experience with the N5 sound processor
- •Prior documentation of sentence recognition testing in noise at a difficulty of +10 dB SNR or better
- •Native English speaker
- •Willingness to participate in and comply with all requirements of the protocol
排除标准
- •Unrealistic expectations
- •Unwillingness to comply with investigational requirements of the protocol
- •Additional handicaps that would prevent or restrict participation in the evaluations
结局指标
主要结局
Endpoint 1: Evaluation of Signal to Noise Ratio - Noise Reduction
时间窗: Visit 2, 1 month after baseline testing
Speech understanding in noise using AzBio sentences with and without the SNR - noise reduction algorithm enabled. Speech understanding at a fixed +10 dB signal to noise level in each condition (on/off) is scored as percent correct and then subtracted to demonstrate the percent difference (benefit) in performance of having the algorithm on vs off.
Endpoint 2: Evaluation of SCAN
时间窗: Visit 2, 1 month after baseline testing
Speech understanding in noise using AzBio sentences with and without SCAN algorithm enabled. Speech understanding at a fixed +10 dB signal to noise level in each condition (on/off) is scored as percent correct and then subtracted to demonstrate the percent difference (benefit) in performance of having the algorithm on vs off.
次要结局
未报告次要终点