Implantation With the Cochlear Nucleus® CI532 Implant - Early Experience Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cochlear
- 入组人数
- 24
- 试验地点
- 12
- 主要终点
- Speech Understanding (% Correct) on AzBio Sentences in Noise in the Implanted Ear
研究概览
简要总结
To evaluate performance outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array.
详细描述
To compare speech perception and audiometric outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array at 3 months postactivation with their best preoperative hearing status.
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
- 12 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medical and audiological candidate for a CI532 cochlear implant per commercially approved, age appropriate, FDA indications
- •Post-linguistically deafened
- •Ability to complete age appropriate testing
排除标准
- •Previous cochlear implantation in the ear to be implanted
- •Pre-linguistically deafened (onset of hearing loss at less than two years of age)
- •Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
- •Diagnosis of retro-cochlear pathology
- •Diagnosis of auditory neuropathy
- •Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device
- •Unwillingness or inability to comply with all investigational requirements
- •Additional cognitive handicaps that would prevent participation on all study requirements
研究组 & 干预措施
Implanted
Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant
干预措施: Cochlear Nucleus CI532 (Device)
结局指标
主要结局
Speech Understanding (% Correct) on AzBio Sentences in Noise in the Implanted Ear
时间窗: 3 months post-activation
unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in noise
Speech Understanding (% Correct) on AzBio Sentences in Quiet in the Implanted Ear
时间窗: 3 months postactivation of the sound processor
Unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in quiet.
次要结局
未报告次要终点