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临床试验/NCT03243097
NCT03243097已完成不适用

Contralateral Routing of Signal in Unilateral Cochlear Implant Users

University of Miami2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2017年8月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
9
试验地点
2
主要终点
Speech perception in noise

研究概览

简要总结

Bilateral profound sensorineural hearing loss (PSNHL) is often treated with Cochlear Implants. The majority of bilaterally deafened patients, however, often only receive a unilateral cochlear implant (CI), with resultant limitations related to monaural listening. For unilateral CI users, the deficits inherently associated with monaural listening remain despite the considerable benefits achieved through implantation. Providing bilateral input to monaural listeners (MLs) overcomes some of these disadvantages. Treatment by contralateral routing of signal (CROS) hearing aids, where the signal of interest is routed from the impaired (deaf) ear to the normal cochlea for processing is a promising alternative in unilateral CI recipients who cannot benefit from bilateral CIs. Utilizing CROS technology provides a less invasive alternative for patients who are unable or unwilling to undergo a second CI surgery and offers an innovative approach to resolving the auditory deficits associated with monaural listening. CROS technology has been used to treat traditional monaural listeners since 1965. When applied to unilateral CI users, this novel approach can overcome a key limitation of current treatment by restoring access to sound from the non-implanted ear and improving speech perception in noise.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Device Feasibility
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

  • Unilateral Advanced Bionics CI recipient
  • ≥ 6 months CI-listening experience and/or better than 50%-word recognition on Consonant-Nucleus-Consonant (CNC) word testing
  • English speaking

排除标准

  • Subjects who do not meet one or more of the above mentioned inclusion criteria are excluded from the study

结局指标

主要结局

Speech perception in noise

时间窗: 8 weeks

Speech perception in noise will be evaluated with the subjects cochlear implant alone and then with the combined application of CROS technology to the cochlear implant.

次要结局

  • Subjective Benefit(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hillary A Snapp

Assistant Professor

University of Miami

研究点 (2)

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