Clinical Utility of Residual Hearing in the Cochlear Implant Ear

人工耳蜗植入耳残余听力的临床应用

• 批准号: 10045323
• 负责人: Oliver Franz Adunka
• 金额: $ 92.17万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-01 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10045323
• 关键词: Acoustic Stimulation; Acoustics; Address; Algorithms; Auditory; Biological Markers; Clinical; Cochlea; Cochlear Implants; Cochlear implant procedure; Ear; Electrocochleographies; Electrodes; Electrophysiology (science); Enrollment; Feedback; Goals; Hearing; Hearing Aids; Implant; Implanted Electrodes; Intraoperative Monitoring; Ipsilateral; Knowledge; Literature; Measures; Methods; Monitor; Music; Noise; Operative Surgical Procedures; Outcome; Outcome Measure; Patients; Perception; Performance; Positioning Attribute; Postoperative Period; Probability; Protocols documentation; Quality of life; Randomized; Reporting; Residual state; Secondary to; Speech Perception; Surgeon; System; Technology; Time; Trauma; arm; base; clinical practice; design; evidence base; functional status; hearing impairment; hearing preservation; implantation; improved; improved outcome; new technology; preservation

Abstract A major concern in cochlear implantation is the loss of residual hearing associated with surgery. Hence, many candidates are faced with the decision to relinquish their remaining acoustic hearing in exchange for electric hearing via the cochlear implant (CI). A potential solution is a stimulation strategy termed Electric acoustic stimulation (EAS), which has been used to describe the ipsilateral combination of electric hearing via a CI and acoustic hearing via a hearing aid. This, however, requires preservation of residual hearing, which has been possible but inconsistent. A new technology to potentially improve hearing preservation, intraoperative electrocochleography (ECochG), has been introduced and it was recently implemented into commercially available CI systems. Studies comparing EAS with conventional CI have were able to demonstrate a performance benefit of EAS. However, these studies have compared conventional CI candidates to EAS candidates with more residual hearing. Thus, the clinical importance of residual acoustic hearing in cochlear implantation (CI) remains unclear. Therefore, the present protocol seeks to answer two critical clinical questions in cochlear implantation: (Specific Aim 1) Are cochlear implant electrode insertions using Electrocochleography (ECochG) feedback better for achieving hearing preservation (HP) and (Specific Aim 2) is combined ipsilateral EAS better than non-HP (conventional) cochlear implantation among CI candidates with substantial residual hearing (EAS candidates). We plan to enroll and randomize EAS candidates in seven large US centers. Patients will be assigned to either intraoperative ECochG monitoring or conventional CI electrode insertions. Hearing preservation and other performance outcomes will be recorded and analyzed between the groups to assess the clinical value of intraoperative monitoring. Further, subjects from both groups will have either useable or no useable residual hearing as the result of surgery. Audiometric and patient reported performance outcomes will be obtained and evaluated for 24 months following initial stimulation. In summary, the present proposal aims to answer two critical clinical questions: Is CI electrode insertion based on ECochG better for achieving HP? and Is EAS better than conventional cochlear implantation among EAS candidates? A positive answer to these questions will inform an evidence-based clinical practice for EAS candidates that uses longer electrodes, broadens the candidate pool by including patients with greater levels of residual hearing, and potentially improves outcomes following CI.

抽象的 人工耳蜗的主要问题是与手术相关的残留听力丧失。因此， 许多候选人面临决定放弃其剩余声学听证的决定以换取 通过人工耳蜗（CI）的电气听力。潜在的解决方案是一种称为电气的刺激策略 刺激（EAS），用于描述通过CI和CI和 通过助听器的声学听力。但是，这需要保存剩余的听力，这已经是 可能但不一致。一种可能改善听力保存，术中的新技术 电卵石学（ECOCHG）已被引入，最近被商业地实施 可用的CI系统。 将EA与常规CI进行比较的研究能够证明EA的性能优势。 但是，这些研究已将常规CI候选物与EAS候选者进行了比较 听力。因此，在人工耳蜗（CI）中残留声听力的临床重要性尚不清楚。 因此，本协议试图在人工耳蜗中回答两个关键的临床问题： （特定目的1）是使用电卵形学（ECOCHG）反馈的人工耳蜗植入物电极插入 为了实现听力保存（HP）和（特定目标2），相比非HP比非HP更好 （常规）具有大量残留听力（EAS候选者）的CI候选者之间的人工耳蜗植入。 我们计划在美国七个大型中心注册和随机分配EAS候选人。患者将被分配给 术中ECOCHG监测或常规CI电极插入。听力保存和其他 两组之间将记录和分析性能结果，以评估 术中监测。此外，来自两组的受试者将具有可用或无用的剩余 手术后听力。听力学和患者报告的表现结果将获得，并 初始刺激后评估24个月。 总而言之，目前的建议旨在回答两个关键的临床问题：是CI电极插入 基于ECOCHG更好地实现HP？并且比传统的人工耳蜗植入更好 EAS候选人？对这些问题的积极答案将为EAS提供基于证据的临床实践 使用更长的电极的候选者，通过包括较高水平的患者来扩大候选池 剩余的听力，并有可能改善CI后的结果。