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临床试验/NCT01066780
NCT01066780已完成不适用

Evaluation of the ClearVoice™ Strategy in Adults Using HiResolution® Fidelity 120® Sound Processing

Advanced Bionics22 个研究点 分布在 2 个国家目标入组 48 人开始时间: 2010年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
22
主要终点
Speech Perception of Standardized Sentences Presented From Recorded Format in Speech-spectrum Noise

研究概览

简要总结

The purpose of this study is to collect information about how the new sound-processing affects the ability to hear in everyday listening situations.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Post-lingually deafened,
  • experienced (6 months device use),
  • adult users of the Harmony HiResolution Bionic Ear System and HiRes Fidelity 120 sound processing.
  • English language proficiency

排除标准

  • 未提供

结局指标

主要结局

Speech Perception of Standardized Sentences Presented From Recorded Format in Speech-spectrum Noise

时间窗: 4 Weeks

This was a within subjects design where scores on the AzBio sentence test in speech spectrum noise were compared against quiet scores at the 2-Week and 4-Week Follow-up Visit. The AzBio corpus of sentences consists of 33 lists of 20 sentences each (6 to 10 words per sentence) that have been equated for intelligibility. Two AzBio sentence lists were scored at each follow-up visit (2-Week and 4-Week) with either ClearVoice MEDIUM or ClearVoice HIGH enabled and averaged together. Two AzBio sentence lists were also administered in quiet at each visit. The ClearVoice score minus the quiet score provided the difference in score for the analysis.

次要结局

  • The AzBio Sentences Will be Administered in Recorded Format in Multi-talker Babble.(2-4 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (22)

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