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: 10225378
• 负责人: Oliver Franz Adunka
• 金额: $ 82.82万
• 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/10225378
• 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