NCT01072409已完成不适用
Clinical Evaluation of the Nucleus 5 Cochlear Implant System
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
- 49
- 试验地点
- 2
- 主要终点
- CNC Monosyllabic Word Performance - Treated Ear
研究概览
简要总结
To evaluate the performance of the Nucleus 5 Cochlear Implant System.
详细描述
Performance outcomes of newly implanted adult recipients using the Nucleus 5 Cochlear Implant System.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eighteen years of age or older at the time of the study.
- •Postlinguistic onset of bilateral severe-to-profound sensorineural hearing loss
- •Bilateral severe-to-profound hearing loss that meets current cochlear implant criteria (<50% open-set sentence recognition in quiet scores in the ear to be implanted and <60% in the best-aided condition)
- •English spoken as the primary language.
- •Willingness to participate in and to comply with all requirements of the study
- •Subject may receive bilateral simultaneous cochlear implants.
排除标准
- •Previous cochlear implant experience
- •Congenital hearing loss (for the purpose of this study, onset prior to 2 years-of-age).
- •Ossification, absence of cochlear development or any other cochlear anomaly that might prevent complete insertion of the electrode array.
- •Normal hearing in one or both ears.
- •Hearing loss of neural or central origin (e.g., deafness due to lesions on the acoustic nerve or central auditory pathway).
- •Active middle-ear infection.
- •Unwillingness and/or inability of the candidate to comply with all investigational requirements including, but not limited to, study protocol and surgical procedure.
结局指标
主要结局
CNC Monosyllabic Word Performance - Treated Ear
时间窗: 12 months
CNC Word Test is a validated test of open-set word recognition. The test consists of 10 lists with 50 monosyllabic words in each list. Subject responses are scored for both words and phonemes correct in the correct sequence. Subjects will be tested using a configuration of speech at 0º azimuth in quiet.
次要结局
未报告次要终点
研究者
研究点 (2)
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