NCT06301581招募中不适用
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Freiburger monosyllabic word recognition score in quiet in the implanted ear
研究概览
简要总结
This is a retrospective study designed to collect speech perception results for HiRes Ultra CI and HiRes Ultra 3D CI users as measured in the clinical routine and to confirm the performance of these devices.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral or bilateral HiRes Ultra CI or HiRes Ultra 3D CI users including
- •Ultra Version V2 newly implanted on this side (Group 1)
- •Ultra Version V2 users implanted following an Ultra Version V1 device failure in the same ear (Group 2)
- •Informed consent signed
排除标准
- •no exclusion criteria
结局指标
主要结局
Freiburger monosyllabic word recognition score in quiet in the implanted ear
时间窗: 12 months after device activation
Score obtained with the Freiburger Monosyllabic word test
次要结局
未报告次要终点
研究者
研究点 (1)
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