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 人工耳蜗植入的一个主要问题是与手术相关的残余听力损失。因此， 许多候选人面临着放弃剩余的声学听证会以换取 通过人工耳蜗 (CI) 实现电听觉。一个潜在的解决方案是一种称为电声学的刺激策略 刺激 (EAS)，已用于描述通过 CI 和电听觉的同侧组合 通过助听器进行听觉。然而，这需要保留残余听力，这已被 可能但不一致。一项可能改善术中听力保护的新技术 耳蜗电描记术 (ECochG) 已被引入，并且最近已投入商业应用 可用的 CI 系统。 将 EAS 与传统 CI 进行比较的研究已经证明了 EAS 的性能优势。 然而，这些研究将传统 CI 候选者与具有更多残留的 EAS 候选者进行了比较。 听力。因此，残余听觉听力在人工耳蜗植入（CI）中的临床重要性仍不清楚。 因此，本方案旨在回答人工耳蜗植入中的两个关键临床问题： （具体目标 1）使用耳蜗电图 (ECochG) 反馈进行人工耳蜗植入电极插入是否更好 为了实现听力保护 (HP) 和（具体目标 2），同侧 EAS 相结合比非 HP 更好 在具有大量残余听力的 CI 候选人（EAS 候选人）中进行（传统）人工耳蜗植入。 我们计划在美国七个大型中心招募并随机分配 EAS 候选人。患者将被分配至 术中 ECochG 监测或传统 CI 电极插入。听力保护及其他 将记录并分析各组之间的表现结果，以评估临床价值 术中监测。此外，两组受试者要么有可用的残留物，要么没有可用的残留物。 手术后的听力。将获得听力测试和患者报告的表现结果，并 初始刺激后 24 个月进行评估。 总之，本提案旨在回答两个关键的临床问题： CI 电极是否插入 基于 ECochG 更好地实现 HP？ EAS 是否优于传统人工耳蜗植入术？ EAS 候选人？对这些问题的积极回答将为 EAS 的循证临床实践提供信息 使用较长电极的候选人通过纳入具有更高水平的患者来扩大候选人库 残余听力，并可能改善 CI 后的结果。