NCT01815788已完成不适用
Evaluation of Efficacy and Patient Acceptance of Sound Amplifier Téo First, in Mild and Moderate Presbycusis Patient 60 Years of Age and Older, With no Previous Hearing Aid.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Audiometric tests (pure tone and speech) in silence and noise, with and without Teofirst
研究概览
简要总结
A personal sound amplifying device (PASP) like Teo First is a wearable electronic product that is not intended to compensate for impaired hearing, but rather is intended for non-hearing impaired consumers to amplify sounds in the environment for a number of reasons, such as for recreational activities. Nevertheless, a lot of mild and moderate impaired hearing people don't want to buy and wear all day a real hearing aid.
The goal of our study is to evaluate the benefit of such a device for mild and moderate presbycusis patient 60 years of age and older, with no previous hearing aid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Wish to increase hearing
- •Moral commitment to use the device
- •Ability to understand the study
- •Mild and moderate presbycusis (20 to 50 dB average hearing loss at 500, 1000, 2000 Hz and 4000 Hz)
- •Patient 60 years of age and older,
- •No previous hearing aid
排除标准
- •Inability to use the device
- •Previous use of a hearing aid
- •local intolerance
结局指标
主要结局
Audiometric tests (pure tone and speech) in silence and noise, with and without Teofirst
时间窗: 7 to 15 days after the first use of Teofirst
次要结局
- audiometric and mental tests(D7 to 15 and D 40)
研究者
研究点 (2)
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