Clinical Investigation of the Safety and Performance of HiResTM Ultra Cl HiFocusTM SlimJ Electrode (Cl-1600-05) and HiResTM Ultra 3D Cl HiFocusTM SlimJ Electrode (Cl-1601-05) (Ultra X) in Adults With Severe-to-profound Hearing Loss
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 5
- 主要终点
- Speech recognition score (word score)
研究概览
简要总结
This is a prospective study designed to evaluate the safety and performance of the HiResTM Ultra Cl HiFocusTM SlimJ Electrode and HiResTM Ultra 3D Cl HiFocusTM SlimJ Electrode (Ultra X) under normal conditions of use as it is approved for this device. Participants receive interventions as part of routine medical care.
详细描述
This study is set up to document any adverse events and comparing pre- to post-implant benefit to subjects. Any adverse events associated with the device will be documented via Advanced Bionics complaint handling system for the lifetime of the device. A within-subjects repeated-measures design will be employed. Speech perception will be evaluated preoperatively with conventional amplification to determine candidacy and to establish baseline performance. Efficacy parameters are speech perception data which will be collected according to clinical routine with a 6 month follow up period. Subjects will be implanted unilaterally with the Ultra X according to standard clinical care.
The primary efficacy objective is to demonstrate that mean monosyllabic word recognition score with the Ultra X used in combination with a sound processor programmed with the latest fitting software six months after activation is at least 20% better than the mean word score at baseline with conventional amplification in the same ear.
The primary efficacy endpoint is reached six months after device activation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •No previous experience with any auditory implant
- •18 years of age or older
- •Postlingual onset of severe hearing loss (≥ 4 years of age)
- •Limited benefit from appropriately fitted hearing aids, defined as scoring 60% or less in Freiburger Monosyllabic word test
- •German language proficiency
- •Willingness to participate in all scheduled procedures outlined in the protocol
排除标准
- •Cochlear malformation or obstruction that would preclude full insertion of electrode array.
- •Presence of additional disabilities that would prevent or interfere with participation in the required study procedures
- •Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study related procedures
- •Evidence of central auditory lesion or compromised auditory nerve
- •Pregnancy at time of surgery.
结局指标
主要结局
Speech recognition score (word score)
时间窗: 6 months
The primary efficacy objective is to demonstrate that mean monosyllabic word recognition score (Minimum Score 0 percent and maximum score 100 percent wheras 0 percent is worse and 100 is better) with the Ultra implants used in combination with a sound processor programmed with the latest fitting software is at least 20 percent better than the mean monosyllabic word score at baseline with conventional amplification in the same ear.
Analysis of participants with device failure
时间窗: 6 months
A maximum of one device failure that require device replacement during the first six months following device activation (activation approximately one to eight weeks after surgery).
次要结局
- Analysis of Speech reception threshold(6 months)