NCT06817928已完成不适用
Evaluation of the AudioKey 3 App
MED-EL Elektromedizinische Geräte GesmbH1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2025年3月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- The primary objective of this clinical investigation is to confirm the performance of the AudioKey 3 app as assessed by a user survey
研究概览
简要总结
Investigating the performance and safety of the AudioKey 3, a device that provides remote control options and status information for compatible MED-EL audio processors, by analyzing data logged by the app and responses to a user survey.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MED-EL CI and audio processor users
- •MED-EL AudioKey 3 users
排除标准
- •Lack of compliance with any inclusion criteria
结局指标
主要结局
The primary objective of this clinical investigation is to confirm the performance of the AudioKey 3 app as assessed by a user survey
时间窗: At time of device use
The primary objective of this clinical investigation is to confirm the performance of the AudioKey 3 app as assessed by a user survey
次要结局
- App user ratings obtained via user survey(At time of device use)
- App usage time obtained from data logging information(up to 12 months)
- Device-related complications collected via user survey(At time of device use)
- Audio processor use obtained from data logging information(up to 12 months)
- • Type of implants, audio processors, auditory scenes (e.g. speech in quiet or noise) obtained from data logging information(up to 12 months)
研究者
研究点 (1)
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