Nucleus Hybrid L24 Implant System: New Enrollment Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cochlear
- 入组人数
- 52
- 试验地点
- 38
- 主要终点
- Change in Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet for the Two Listening Conditions: Implant Ear Alone and When Using Both Ears Together From Pre-operatively Through 3 Years Post-activation of the Device
研究概览
简要总结
This study evaluates the long term safety and effectiveness of the Nucleus Hybrid L24 Implant in a group of newly implanted adults.
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
- 否
入选标准
- •Ear to Be Implanted:
- •Normal to moderate hearing loss in the low frequencies with severe to profound mid to high frequency hearing loss in the ear to be implanted
- •CNC word recognition of 10-60% in the ear to be implanted
- •Contralateral Ear:
- •Moderately severe to profound mid to high frequency hearing loss in the contralateral ear
- •CNC word recognition equal to or better than that in the ear to be implanted but not more than 80% correct
排除标准
- •not proficient in English
- •unwilling and/or unable to comply with the test protocol
- •deafness due to lesions of the acoustic nerve or central auditory pathway.
- •active middle-ear disease, with or without tympanic membrane perforation.
- •absence of cochlear development.
- •duration of severe to profound hearing loss of 30 years or greater
结局指标
主要结局
Change in Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet for the Two Listening Conditions: Implant Ear Alone and When Using Both Ears Together From Pre-operatively Through 3 Years Post-activation of the Device
时间窗: From pre-operatively through 3 years post-activation of the device
The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in CD format. For this study, two lists will be administered in quiet at a level equal to 60 dBA in the sound field and recorded as a total number of words correct, which will be expressed as a percentage correct for this study. The CNC word test has a score range of 0-100% with higher values indicating better scores.
Number of Device or Procedure Related Adverse Events
时间窗: Up to 5 years post-activation of the device
次要结局
- Change in AzBio Sentence Recognition in Noise in the Best Unilateral Condition(Pre-operatively, up to 3 years post-activation of the device)