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临床试验/NCT03756337
NCT03756337已完成不适用

Comparison of Audiometric Performance Between the Neuro 1 and Neuro 2 Sound Processors.

Oticon Medical1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年11月1日最近更新:
适应症

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

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)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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