Early Identification of Age-related Hearing Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Comparison between the automated hearing screening self-test result and the gold-standard hearing test result performed with clinical Audiometer by an Audiologist.
研究概览
简要总结
The need for future hearing rehabilitation is enormous. World Health Organization (WHO 2021) has estimated that by 2050, 2.5 billion people will have some degree of hearing loss, and 1/4 of them will require hearing rehabilitation. Currently, healthcare systems and processes are already overwhelmed and not adequately equipped to screen and diagnose this rapidly growing population suffering from hearing impairment. This study aims to investigate if the diagnostics of age-related hearing loss can be accelerated by involving patients in the hearing assessment process.
详细描述
The investigational device used in the study is part of the Otoscreen hearing screening system that is developed by Aalto University.
The investigational device consists of the following parts:
- Digital otoscope
- User interface control unit.
The investigational device is designed to record high-quality images and videos of the eardrum and ear canal and guide users through a hearing screening test while collecting data from questionnaires, digital otoscopy, and audiometry.
The investigational device is used together with a CE-marked audiometer that is intended for hearing screening testing.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be able to understand Finnish or Swedish
排除标准
- •Clinical diagnosis of hearing loss
结局指标
主要结局
Comparison between the automated hearing screening self-test result and the gold-standard hearing test result performed with clinical Audiometer by an Audiologist.
时间窗: From hearing tests to the comparison (up to six months).
The investigators compare pure tone averages.
Comparison between investigational device and gold-standard device (otomicroscope) findings.
时间窗: From digital otoscopy to the interpretation of pictures (up to six months).
The investigators compare scored views to the outer ear canal and tympanic membrane.
次要结局
- Participant group 1: REM measurements.(From REM measurements to the analysis of the results (up to six months).)
- Participant group 2: The usability of the investigational device.(From study appointment to the analysis of the results (up to six months).)