The Neuro Zti Cochlear Implant System Efficacy and Safety in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 6
- 主要终点
- Change in Hearing In Noise Test Score in Quiet (HINT-Q) From Baseline to 6 Months in English-speaking Participants.
研究概览
简要总结
The purpose of the study is to assess the efficacy and the safety profile of the Neuro Cochlear Implant System (CIS) in adults with severe-to-profound hearing loss.
详细描述
Appropriate adult cochlear implant candidates with sensorineural hearing loss, from English French Canadian centres and Danish centre, received Neuro Zti cochlear implant and fit with Neuro One sound processor.
Speech perception testing, using HINT (Hearing In Noise Test) sentences in quiet (65 dB SPL) (decibel, Sound Pressure Level) and in noise (+10 dB SNR) (decibel, Signal-to-Noise-Ratio), will be administrated pre-operatively in the best listening conditions and 3, 6, and 12 months post-activation in the implanted ear.
Adverse events will be collected during the surgery and over the post-surgical period from activation to12 months post-activation.
Safety will be assessed on the overall English, French and Danish participants. Efficacy will be assessed on English speaking participants.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in Hearing In Noise Test Score in Quiet (HINT-Q) From Baseline to 6 Months in English-speaking Participants.
时间窗: pre-operative, 6 Months
To assess the clinical efficiency, speech perception performance using the HINT sentences was measured in quiet at 6 months pos-activation in English speaking participants. Primary clinical efficiency outcome is defined as the change in HINT scores from baseline to 6 months post-activation. Recorded HINT sentences lists were presented to the participant at 60 dB SPL (sound pressure level) pre-operatively in the best aided hearing conditions and at 6 months in the implanted ear after Neuro Zti implant activation. The post-activation assessment was performed in the implanted ear alone with masked controlateral ear. Resultant score is a percentage of words correctly repeated. Possible scores are range from 0% to 100% words correctly repeated. Change = (6 Months score - Baseline score). A score greater or equal to 10% was considered clinically significant improvement.
Major Related Adverse Event (AE)
时间窗: 12 months
Adverse event (AE) is defined as any undesired change from the participant's baseline condition symptom or clinically relevant symptom or disease, regardless of its cause. AEs include complications that are related to the device or clinical procedure, as well as unrelated AE that are not related to the device or the trial procedure. AEs were classified as Major if they corresponded to any of the following criteria: * life-threatening conditions (e.g. meningitis) * require hospitalization * result in permanent disability or damage (e.g. facial nerve paresis) * require revision surgery with or without explantation or re-implantation (e.g. device failure, flap necrosis) * medical events that could not be alleviated by electrode deactivation (e.g. tinnitus, facial nerve stimulation, pain) The co-primary safety endpoint is the major related adverse events rate during the surgery and over the post-surgical period from activation to 12 months post-activation.
次要结局
- Hearing In Noise Test Score in Noise (HINT-N) Pre-operatively, at 3-, 6- and 12-Months on English-speaking Participants(pre-operative, 3-, 6- and 12-Months)
- Minor Adverse Events (AE)(12 months)
- Clinical Benefit on English-speaking Participants(3, 6 and 12 months)
- Hearing In Noise Test Score in Quiet (HINT-Q) Pre-operatively, at 3-, 6- and 12-Months on English-speaking Participants(pre-operative, 3, 6 and 12 Months)