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临床试验/NCT05072457
NCT05072457已完成不适用

Benefit of Assistive Listening Device for Lateralization and Spatial Hearing

Sonova AG2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年10月18日最近更新:
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
Lateralization Hearing Ability

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 a Phonak Roger microphone and hearing aid with compatible Phonak Roger receiver. Target speech will be presented from multiple directions while competing diffuse background noise is presented simultaneously. Participants will repeat back words and percent correct is calculated.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Experienced hearing aid users, age 18 or older
  • Bilateral, symmetric moderate to moderate-severe sensorineural hearing loss
  • Good understanding of the English language
  • Health outer ear as confirmed by otoscopy
  • Informed consent as documented by signature

排除标准

  • Contraindications to the medical device noted upon otoscopy
  • Known hypersensitivity or allergies to materials of the investigations device or comparator
  • Inability to produce reliable test results
  • Known psychological problems
  • Self reported symptoms of vertigo or dizziness

结局指标

主要结局

Lateralization Hearing Ability

时间窗: Day 1 of 1 day study

Participants indicate which direction (left, center, or right) target speech sentences are coming from while competing noise is also presented via four corner speakers. A higher number of correct responses indicates better lateralization ability. This will be done with two Roger microphone systems (Roger On and Roger Select)

Spatial Hearing Ability

时间窗: Day 1 of 1 day study

Participants repeat sentences presented from the left speaker, while ignoring overlapping competing sentences presented from the right speaker. A higher percentage of correctly repeated words indicates a better spatial hearing score. This task will be performed using two Roger microphone systems (Roger On and Roger Select)

次要结局

未报告次要终点

研究者

发起方
Sonova AG
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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