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临床试验/NL-OMON43822
NL-OMON43822已完成不适用

Directional Microphone Systems for Bimodal Listeners - Bimodal Zoom

Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • Bimodal group:
  • In order to be eligible to participate in the bimodal group of this study, a subject must meet all of the following criteria:
  • * capacitated adult (>18 years of age)
  • * patient of CI-team South-East Netherlands
  • * user of a unilateral cochlear implant (CI) of the brand Advanced Bionics (AB)
  • * first fit CI ><= 6 months ago
  • * wearing CI speech processor (almost) always (i.e. circa 10 hours a day)
  • * wearing a contralateral hearing aid >50% of the time (i.e. circa 5 hours a day)
  • * able to perform the speech-in-noise test (i.e. speech recognition in quiet >50%)
  • * willing and able to visit the azM and participate in testing
  • * agreed to participate in this study (by informed consent);Bilateral group:
  • In order to be eligible to participate in the bilateral group of this study, a subject must meet all of the following criteria:
  • * Capacitated adult (>18 years of age)
  • * Patient of CI-team azM, RadboudUMC or UMCU
  • * Former subject in the study *Bilateral Cochlear Implantation Benefits in Adult Users of the HiRes(R)
  • * 90K Bionic Ear System* (NL24660.018.08/NTR1722) who completed the full follow-up period of four years since the first implantation
  • * User of bilateral cochlear implants (CI*s) of the brand Advanced Bionics (AB)
  • * First fit of second CI *<= 6 months ago
  • * Wearing CI speech processor in both ears (almost) always (i.e. circa 10 hours a day)
  • * Able to perform speech-in-noise test (i.e. speech recognition in quiet with bilateral CI >50%)
  • * Willing and able to visit the azM and participate in testing
  • * Agreed to participate in this study (by informed consent);And additionally in the case of a patient of CI-team UMCU or RadboudUMC:
  • * Agreed to let the research team of the current study inform the own CI-team respectively of his/her participation in the current study (by informed consent)
  • * Agreed to let the research team of the current study retrieve his/her basic audiological information from the CI-team UMCU or RadboudUMC (by informed consent)

排除标准

  • Bimodal group:
  • A potential subject who meets any of the following criteria will be excluded from participation in the bimodal group:
  • * non fluent in Dutch
  • * < 18 years of age or incapacitated
  • * bilateral cochlear implant user (CI+CI) ;Bilateral group:
  • A potential subject who meets any of the following criteria will be excluded from participation in the bilateral group:
  • * non fluent in Dutch
  • * < 18 years of age or incapacitated

研究者

发起方
Medisch Universitair Ziekenhuis Maastricht

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