Clinical Utility of Residual Hearing in the Cochlear Implant Ear

摘要 人工耳蜗术中的一个主要问题是与手术相关的残留听力的丧失。因此， 许多候选人面临着放弃剩余的声学听证以换取 经人工耳蜗术(CI)的电听力。一个潜在的解决方案是一种称为电声的刺激策略 刺激(EAS)，已被用来描述通过CI和 通过助听器进行声学听力。然而，这需要保留剩余的听证，这已经被 有可能，但不一致。一种潜在改善听力保护的新技术，术中 电子耳蜗术(ECochleography，ECochG)已经被引入，并于最近实现了商业化 可用的CI系统。 比较EAS和传统CI的研究已经能够证明EAS的性能优势。 然而，这些研究将传统CI候选对象与残差更多的EAS候选对象进行了比较 听证。因此，残留声学听力在人工耳蜗术(CI)中的临床重要性仍不清楚。 因此，本方案试图回答人工耳蜗术中的两个关键临床问题： (具体目标1)使用耳蜗术(ECochG)反馈的人工耳蜗术电极植入效果更好 为了达到听力保护(HP)和(特定目的2)相结合，同侧EAS比非HP更好 (常规)在听力明显残留的CI患者(EAS患者)中植入人工耳蜗术。 我们计划在美国七个大型中心招收EAS考生并对其进行随机化。病人将被分配到 术中ECochG监测或常规CI电极置入术。听力保全和其他 将在两组之间记录和分析性能结果，以评估 术中监护。此外，两组受试者都将有可用或无可用残留物 作为手术结果的听力。将获得听力测量和患者报告的表现结果，并 在最初刺激后进行24个月的评估。 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？在以下几个方面，EAS比传统的人工耳蜗术更好 EAS候选人？对这些问题的肯定回答将有助于EAS的循证临床实践。 使用更长电极的候选对象，通过包括具有更高水平的 残留听力，并有可能改善CI后的预后。

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.