NCT05072470已完成不适用
Benefits of an Assistive Listening Device for Speech Intelligibility in Noise
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sonova AG
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Speech Intelligibility in Noise
研究概览
简要总结
Speech intelligibility in noise will be evaluated in adults with moderate to moderate-severe sensorineural hearing loss, using an assistive listening device and hearing aid, and compared to speech intelligibility in noise using hearing aids alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults age 18 or older with bilateral moderate to moderate severe sensorineural hearing loss, pure tone average must be between 40 and 69 dB HL (decibel Hearing Level)
- •experienced hearing aid users
- •symmetric hearing loss (no more than 15 dB difference between the ears at three contiguous frequencies)
- •good written and spoken English language skills
- •healthy outer ear as confirmed by otoscopy
排除标准
- •contradictions to medical device noted upon otoscopy
- •known hypersensitivity or allergy to materials of investigational device or comparator
- •inability to produce reliable test results
- •known psychological problems
- •self reported symptoms of dizziness or vertigo
结局指标
主要结局
Speech Intelligibility in Noise
时间窗: Day 1 of a one day study
The percent of correctly repeated words, when a list of 10 sentences is presented in noise. Ten sentences are presented at a certain loudness level while background noise is presented simultaneously at a specific loudness level. The number of words repeated correctly is calculated from the total number of words presented.
次要结局
未报告次要终点
研究者
研究点 (2)
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