Digital Audiometer vs. Conventional Audiometer (Gold Standard): Study of Tonal and Vocal Recognition Thresholds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- auditory threshold levels and speech recognition thresholds
研究概览
简要总结
According to the WHO (February 2, 2024): More than 5% of the world's population, or 430 million people (including 34 million children), need rehabilitation services due to disabling hearing loss. It is estimated that 700 million people will be affected by 2050, or one in 10 people. It is estimated that by 2050, nearly 2.5 billion people will have some degree of hearing loss.
In most cases, audiometric testing involves determining the patient's tonal thresholds and speech recognition thresholds.
The Hearing Space device is a digital audiometer that can perform both tonal and speech audiometry. This device stands out because it allows users to calibrate its transducers themselves via a guided, automated procedure. This procedure ensures that the calibration complies with the relevant calibration standards.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have come to the ENT department for an audiometric examination
- •Adult patients (aged 18 or over), regardless of weight, gender, ethnicity, etc.
- •Patients whose native language is French.
- •Able to understand instructions. Person affiliated with or beneficiary of a social security system.
- •Free, informed, and written consent signed by the participant and the investigator (no later than the day of inclusion and before any examination required by the research).
排除标准
- •Patients with known/confirmed unilateral cochlear deafness
- •Adults deprived of liberty or under guardianship
- •Pregnant women
- •Patients with only one ear
研究组 & 干预措施
Hearing Space audiometer first
Hearing Space audiometer first, then AC40 audiometer
干预措施: Hearing Space audiometer first, then AC40 audiometer (Device)
AC40 audiometer first
AC40 audiometer first, then Hearing Space audiometer
干预措施: AC40 audiometer first, then Hearing Space audiometer (Device)
结局指标
主要结局
auditory threshold levels and speech recognition thresholds
时间窗: From inclusion to the end of the intervention (40 minutes on average)
Measurements of pure-tone audiometric thresholds and speech recognition thresholds will be taken for each of the patient's ears using the Hearing Space digital audiometer and the Interacoustic AC40 physical audiometer (in random order). The results obtained will then be statistically compared to determine whether or not there is a significant difference between the results obtained by the two devices.
次要结局
未报告次要终点