Single-center Non-inferiority Study of Extra-cochlear Electrode Placement at the Post-auricular Vagus Nerve in Cochlear Implantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- AzBio Sentence Recognition Test Score
研究概览
简要总结
This study will evaluate hearing outcomes after cochlear implantation with placement of the ECE1 ground electrode near the post-auricular vagus nerve (Arnold's nerve) to assess non-inferiority with respect to placement under the temporalis muscle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •will be undergoing surgery for a cochlear implant from Cochlear Americas
- •is willing to participate in the study
排除标准
- •has history of prior ear surgery, congenital ear malformation, or prior cochlear implantation in the ear to be implanted
- •pregnant, planning to become pregnant, or breastfeeding patients cannot undergo the standard-of-care implantation procedures required for participation in the study.
研究组 & 干预措施
Patients scheduled for Cochlear Implantation
The experimental arm will enroll patients over the age of 18 undergoing cochlear implantation involving the placement of ECE1 at the approximate location of Arnold's nerve within the ear canal. In the proposed study, a modification to the surgical approach will be done to place ECE1 near Arnold's nerve, while still using a standard electrode array.
干预措施: Cochlear Implant (Device)
Patients scheduled for Cochlear Implantation
The experimental arm will enroll patients over the age of 18 undergoing cochlear implantation involving the placement of ECE1 at the approximate location of Arnold's nerve within the ear canal. In the proposed study, a modification to the surgical approach will be done to place ECE1 near Arnold's nerve, while still using a standard electrode array.
干预措施: Modified Implant Procedure (Device)
结局指标
主要结局
AzBio Sentence Recognition Test Score
时间窗: Up to Year 1 post cochlear implant activation
The AzBio Sentence Recognition Test is a clinical tool used to evaluate a person's ability to understand speech in noisy environments. The total score is the percentage of words correctly understood, ranging from 0-100%.
次要结局
未报告次要终点