Real-Ear Measurement (REM) and Test Box System Integration Into Fitting Software
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 205
- 试验地点
- 2
- 主要终点
- Procedure time (min) of fitting workflow including Real Ear measurement
研究概览
简要总结
Integration of the REM-verification within the fitting workflow will enable the hearing care professional to easily run real ear measurements. The purpose of the two study parts is to prove that an integrated cooperative system, consisting of fitting software and measurement system, matches desired responses for certain stimuli faster, more reliably and more precisely at the ear drums of hearing instrument wearers than current best practice processes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 67 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clean and healthy ear canal, eardrum and pinna
- •Ability to keep current position (of head and body) during a period of about 5 minutes while seated.
排除标准
- •Ear infections
- •Ear wax in the ear
- •Hyperacusis
- •Pacemaker
- •Disability to keep position.
结局指标
主要结局
Procedure time (min) of fitting workflow including Real Ear measurement
时间窗: 2 month
In addition to the outcome measurement "time" (in minutes) further outcome measurements can be obtained due to the performed real ear measurement procedure itself. Data that give information pertaining to test reliability (in dB) and precision of hearing aid fitting (in dB).
Distance (mm) from probe tube to eardrum measurement
时间窗: 1 month
Precise of the Probe Tube placement
次要结局
- Subjective rating of unpleasantness (0 = not unpleasant at all, 10 = very unpleasant)(1 month)
- Questionnaire about perceived annoyance(2 month)