NCT03304106已完成不适用
Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cochlear
- 入组人数
- 102
- 试验地点
- 17
- 主要终点
- Change in Monosyllabic Word Recognition Scores (CNC) in Quiet
研究概览
简要总结
Use of Artificial Intelligent (AI) technology to assist audiologists in programming cochlear implants.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly implanted and existing recipient Groups (Groups 1 and 2):
- •Age 12 and older
- •Monosyllabic word score administered at 60dBA (2 lists) with an appropriately fit hearing aid in the ear to be implanted who are receiving a cochlear implant as standard of care
- •Group 2: 3 months or greater combined experience with commercially available sound processors
- •Fluent spoken English skills
排除标准
- •Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations
- •Additional cognitive, medical or social handicaps that would prevent completion of all study requirements as determined by the Investigational team
- •Unwillingness or inability of the subject to comply with all investigational requirements
- •Use of an acoustic component in the implanted ear
- •Less than 18 active electrodes
- •Hybrid L Cochlear Implant
结局指标
主要结局
Change in Monosyllabic Word Recognition Scores (CNC) in Quiet
时间窗: Pre-operative/Visit A; Group 1: 6 months; Group 2: 1 month
Monosyllabic word recognition was scored in quiet using Consonant-Nucleus-Consonant (CNC) words. Scores are listed as percentage correct thus a higher score (percentage) means a better outcome.Group 1: Preoperative to postoperative percentage performance after 6 months of cochlear implant use. Group 2: Visit A to Visit B after 1 month of cochlear implant use.
次要结局
未报告次要终点
研究者
研究点 (17)
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