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【ChiCTR1800019012】黏合式骨導助聽器對傳導性弱聽人士的聽力效益及用者滿意狀況

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基本信息

登记号

ChiCTR1800019012

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2018-10-08

临床申请受理号

靶点

适应症

傳導性弱聽

试验通俗题目

黏合式骨導助聽器對傳導性弱聽人士的聽力效益及用者滿意狀況

试验专业题目

黏合式骨導助聽器對傳導性弱聽人士的聽力效益及用者滿意狀況

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

联系人通讯地址

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临床试验信息

试验目的

黏合式骨導助聽器對傳導性弱聽人士的聽力效益及用者滿意狀況

试验分类

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试验类型

单臂

试验分期

其它

随机化

N/A

盲法

N/A

试验项目经费来源

Dept. of Otorhinolaryngology, Head and Neck Surgery, CUHK

试验范围

目标入组人数

实际入组人数

第一例入组时间

1990-01-01

试验终止时间

1990-01-01

是否属于一致性

入选标准

1. Unilateral or bilateral conductive hearing loss, as defined by the affected ear(s) having bone-conduction thresholds of no worse than 25 dB(HL) at 0.5 – 4 kHz and air-bone gaps of at least 10 dB at three of the tested frequencies; 2. Absence of skin or scalp conditions that may preclude attachment of the adhesive adapter, or interfere with audio processor usage; 3. Aged 6 years and above and can comply with evaluation procedures; 4. Cantonese as the primary language; 5. Willingness to attend extra audiological sessions for evaluating device benefits; 6. Willingness to fill out journal regarding device usage and questionnaires regarding user satisfaction; 7. Willingness and being able to provide daily care to a loaned device; 8. Gives consent to taking part in the study.；

排除标准

1. Does not meet one or more of the inclusion criteria listed above; 2. Any type of hearing loss other than conductive; 3. Health, physical, or cognitive conditions that would interfere with the completion of, participation in, or provision of valid responses during the required audiological evaluations, or interfere with adherence to study procedures.；

研究者信息

研究负责人姓名

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试验机构

The Chinese University of Hong Kong

研究负责人电话

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研究负责人邮箱

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研究负责人邮编

联系人通讯地址

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