Ambispective Clinical Evaluation of Sophono™
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 6
- 主要终点
- Safety Outcome Measure: Proportion of Adverse Events (AEs) Related to Sophono Implant
研究概览
简要总结
Study to accumulate post-market clinical evidence for the safety and effectiveness of the Sophono Alpha 2 and Alpha 2 Maximum Power Output (MPO) systems in subjects diagnosed with conductive hearing loss, single-sided deafness and mixed hearing loss who currently have or have had the Sophono implant.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any subject who currently has or who has had the Sophono implant (including those who have been explanted)
- •Has or has had Sophono implant for 3 months or longer
排除标准
- •Subject has implant but is unable or unwilling to perform audiologic testing
- •Subject is currently participating in another clinical study and has not been approved for concurrent enrollment by the Study Sponsor
结局指标
主要结局
Safety Outcome Measure: Proportion of Adverse Events (AEs) Related to Sophono Implant
时间窗: From Implantation to Study Visit, up to 6 years
The primary safety endpoint is the proportion of AEs related to the Sophono implant, which will be assessed through retrospective surgical chart review and prospective Ear, Nose and Throat (ENT) exam.
Gain in Sensitivity to Sound in Decibels (dB) Resulting From Sophono Alpha 2 Maximum Power Output (MPO) Processor
时间窗: 1 day
The primary efficacy endpoint is the difference (gain) in the free-field pure tone audiometry assessed by pure tone average (PTA) unaided (AC) and aided (BC) by the Alpha 2 MPO processor. Standard audiometry test was used to assess free field pure tone audiometry.
次要结局
- Compare the Effectiveness of the Sophono Alpha 2 Processor to the Alpha 2 MPO Processor(1 day)
- Percentage of Participants Satisfied After System Use(1 day)
- Assess QOL After System Use(1 day)