Comparison of Audiometric Performance Between the Neuro 1 and Neuro 2 Sound Processors.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- speech recognition in quiet
研究概览
简要总结
This study evaluates the benefit of Neuro 1 sound processor upgrade in speech perfomance in adults. Half of participants will be tested with Neuro 1 first and Neuro 2, while the other half will be tested with Neuro 2 first and then Neuro 1.
详细描述
The Neuro 1 processor represented a technological advancement over past models, particularly in detecting the environment and automatically adjusting to the sound environment. A second version of the Neuro 1 processor has been developed, the Neuro 2. The signal processing and stimulation characteristics are similar, so speech comprehension levels are expected to be equivalent. This study is designed to compare Neuro 1 and Neuro 2 in terms of audiometric performance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •written informed consent
- •primary implantation
- •subject having participated to previous Neuro 1 sound processor study in Canada
- •fluent in English, including reading and writing.
排除标准
- •psychologically unsuitable
- •unrealistic expectations regarding possible benefits, risks, and limitations that are inherent to the device
- •non compliant with all investigational requirements.
结局指标
主要结局
speech recognition in quiet
时间窗: Day 1
Hearing In Noise Test
次要结局
- speech recognition in noise(Day 1)
- pure tone threshold(Day 1)
