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临床试验/NCT03515473
NCT03515473已完成不适用

Subjective and Objective Results With CI Electrode Types

Szeged University1 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2015年11月13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
入组人数
139
试验地点
1
主要终点
Intraoperative measurements

研究概览

简要总结

Background The authors' aim was to compare the influence of various electrode designs on selected objective and subjective clinical outcomes for cochlear implant recipients using the same model of receiver-stimulator, Cochlear™ Nucleus® Profile Series and sound processor.

Methods A multicenter study with subjects with profound sensorineural hearing loss, who were implanted and followed up in two tertiary centers. A total of 54 ears were implanted with Cochlear™ Nucleus® CI532, 51 with Cochlear™ Nucleus® CI522 and 54 with the Cochlear™ Nucleus® CI512. Implant loss and intraoperative electrophysiological tests (electrically evoked stapedial reflex threshold [ESRT], neural response telemetry threshold [T-NRT] and impedance), postoperative data (C-level, T-level, dynamic range, T-NRT and power consumption) and intracochlear position of the active electrode were analyzed with Nucleus Custom Sound 4.4 software.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • successful cochlear implantation with CI532 or CI512 or CI522
  • gave informed consent

排除标准

  • unsuccessful cochlear implantation

结局指标

主要结局

Intraoperative measurements

时间窗: 1 day

Neural response telemetry threshold (T-NRT; current unit) with different types of cochlear implants

次要结局

  • Postoperative measurements(3 months)

研究者

发起方
Szeged University
申办方类型
Other
责任方
Principal Investigator
主要研究者

László Rovó

Professor Head of Otorhinolaryngology Clinic

Szeged University

研究点 (1)

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