NCT05869266已完成不适用
A Prospective, Crossover Randomized Controlled Trial to Compare Subjective Outcome of a Self-fitting Process Using Tuned App to a Licensed Professional Fitting
Tuned Ltd.1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2023年5月1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
- 56
- 试验地点
- 1
- 主要终点
- Comparison of self fitting and professional fitting by COSI scores
研究概览
简要总结
The aim of the study is to compare the perceived outcome of the self-fitting performed by the participants using the Tuned mobile application with the traditional professional fitting as performed by a licensed professional audiologist in subjects with mild to moderate sensorineural hearing loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •Adult males and females, 18 years and older.
- •Mild to moderate sensorineural hearing loss.
- •Own and able to use a smart phone (Android or iOS).
- •Able to read and understand Hebrew.
排除标准
- •Conductive mixed hearing loss.
- •Unilateral hearing loss.
- •Any external or inner ear malformations.
- •Symptoms of ear disease or excessive cerumen.
结局指标
主要结局
Comparison of self fitting and professional fitting by COSI scores
时间窗: 4 weeks
To compare the professional fitting and the self fitting using the Tuned App, the scores of Client Oriented Scale of Improvement (COSI) questionnaire will be used.
次要结局
- Comparison of self fitting and professional fitting by IOI-HA scores(4 weeks)
研究者
研究点 (1)
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