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: 10457276
• 负责人: Oliver Franz Adunka
• 金额: $ 84.42万
• 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/10457276
• 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.

摘要 人工耳蜗植入术的一个主要问题是与手术相关的残余听力损失。因此，我们认为， 许多候选人面临着放弃他们剩余的听觉以换取 通过人工耳蜗（CI）实现电听觉。一种潜在的解决方案是一种称为电声的刺激策略 电刺激（EAS），其已用于描述经由CI的电听觉的同侧组合， 助听器的选配然而，这需要保留剩余听证， 可能但不一致。一种可能改善术中听力保护的新技术 耳蜗电描记术（ECochG）已经被引入，并且其最近在商业上被实施到耳蜗电描记术中。 可用的CI系统。 比较EAS与传统CI的研究已经能够证明EAS的性能优势。 然而，这些研究比较了传统的CI候选人与具有更多残差的EAS候选人。 听证会因此，人工耳蜗植入术（CI）中残余声听力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）反馈的人工耳蜗电极插入是否更好 对于实现听力保留（HP）和（特定目标2），同侧EAS联合使用优于非HP 在具有大量残余听力的CI候选人（EAS候选人）中进行（常规）人工耳蜗植入。 我们计划在美国七个大型中心招募和随机选择EAS候选人。患者将分配为 术中ECochG监测或常规CI电极插入。听力保护及其他 将记录并分析各组之间的性能结局，以评估 术中监测此外，两组的受试者将具有可用或无可用的残留 手术后的听力。将获得听力测定和患者报告的性能结局， 在初始刺激后评估24个月。 总之，本提案旨在回答两个关键的临床问题： 基于ECochG更好地实现HP？EAS是否优于传统人工耳蜗植入， EAS候选人？对这些问题的肯定回答将为EAS的循证临床实践提供信息 使用较长电极的候选人通过包括具有更高水平的 残余听力，并可能改善CI后的结果。