DRKS00017648已完成1 期
Optimization of an active tympanic membrane contact lens for future hearing solutions
niversitätsklinikum Tübingen0 个研究点目标入组 7 人开始时间: 2021年3月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 21 Years 至 one（—）
- 性别
- All
入选标准
- •1) Age >= 21;
- •2) normal otoscopic finding;
- •3) average pure-tone threshold PTA4 <= 45 dB HL, pure-tone threshold <=75 dB HL at 6 and 8 kHz;
- •4) air-bone gap <= 10 dB;
- •5) Informed consent signed by participant;
- •6) Subject able to understand pertinent information and provide informed consent
排除标准
- •1) Acute pathology of middle- and/or inner ear (otitis media, labyrinthitis, sudden hearing loss);
- •2) Chronic hearing impairment: Otosclerosis, chronic otitis media mesotympanalis;
- •3) history yof middle-ear surgery;
- •4) ear canal length outside the range specified in the IFU;
- •5) No available size of the ICR (in-the-canal retainer) well tolerable for the study participant;
- •6) Subjects with active implants
研究者
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