Hearing Aid Quality Check and Reliability Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sonova AG
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 1
研究概览
简要总结
Quality and reliability study of hearing aid. Adults with mild to severe hearing loss will wear hearing aids daily for approximately 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults with mild to moderate severe sensorineural hearing loss
- •Adults who were able to incorporate some type of physical activity into their day (i.e walking, excercise, gardening, etc.)
排除标准
- •Unable or unwilling to wear study devices during a home trial
- •Unable or unwilling to come to lab for study visits
结局指标
主要结局
Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 1
时间窗: Day 1 of study
Test box electroacoustic measurements of hearing aid done at full on settings must meet manufacturer product specifications per manufacturer data sheet. This includes maximum and high frequency average output sound pressure level, maximum and high frequency average acoustic gain, frequency response range, total harmonic distortion and equivalent input noise level. This is done using an Audioscan Verifit2 electroacoustic analyzer. Electroacoustic measurements listed above will also be taken with hearing aid set to user settings, as a baseline measure for all future appointments.
Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 45
时间窗: Day 45 of study
Test box electroacoustic measurements (using the Audioscan Verifit 2 Electroacoustic Analyzer) of hearing aid done at user gain settings after daily use for extended period of time. Results will be compared to baseline electroacoustic measures taken on day 1 of study. A "pass" means that devices were within tolerance levels (per ANSI S3.22-2014) of baseline measures. A "fail" means that devices were not within tolerance levels of one or more baseline measures (i.e. output, gain, frequency range, total harmonic distortion, or equivalent input noise level).
Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 90
时间窗: Day 90 of study
Test box electroacoustic measurements of hearing aid done at user gain settings after daily use for extended period of time. Test box electroacoustic measurements of hearing aid done at user gain settings after daily use for extended period of time. Results will be compared to baseline electroacoustic measures taken on day 1 of study. A "pass" means that devices were within tolerance levels (per ANSI S3.22-2014) of baseline measures. A "fail" means that devices were not within tolerance levels of one or more baseline measures (i.e. output, gain, frequency range, total harmonic distortion, or equivalent input noise level).
次要结局
未报告次要终点