Benefits of the HiResolutionTM Bionic Ear System in Adults With Low-Frequency Hearing.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- CI aided word recognition scores in quiet and noise.
研究概览
简要总结
The goal of this investigation is to generate the needed PMCF data for the HiFocus Mid-Scala electrode. As a point of interest the investigators would like to evaluate the benefit to patients with low-frequency residual hearing implanted with the HiFocus Mid-Scala Electrode. The HiFocus Mid-Scala electrode array is designed to allow surgeons the flexibility to use a variety of contemporary surgical techniques that have been shown to enable easy insertion and to minimize cochlear trauma (see, e.g., Adunka and Buchman, 2007; Friedland and Runge-Samuelson, 2009; Roland et al., 2007). Temporal bone experiments have shown the HiFocus Mid-Scala electrode array to be straightforward to insert while causing minimal trauma to cochlear structures during and after surgery (Lenarz et al., 2010). In addition , the HiFocus Mid-Scala has already shown to be a safe electrode and promising post op clinical results in the premarketing study that is now in the final stage.
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 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Definite Postlingual onset of severe-to-profound hearing loss as documented by completing main stream primary education.
- •Local language proficiency
- •Bilateral, sensorineural hearing loss
排除标准
- •Previous inner ear surgery or active middle ear pathology.
- •Cochlear malformation or obstruction
- •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
- •Concurrent participation in other study
结局指标
主要结局
CI aided word recognition scores in quiet and noise.
时间窗: 12 months post activation
CI aided word recognition scores in quiet and noise.
次要结局
未报告次要终点
