Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation

在人工耳蜗植入中提供术中低温治疗以保护听力的装置

基本信息

批准号：
10593170
负责人：
Curtis Scott King
金额：
$ 33.83万
依托单位：
RESTOREAR DEVICES, LLC
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-04-01 至 2026-03-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10593170
关键词：
Acoustics Address Adult Americas Audiology Blood Vessels Cadaver Clinical Clinical Data Clinical Engineering Cochlea Cochlear Implants Cochlear implant procedure Collaborations Coupled Data Deterioration Development Device Designs Device Safety Devices Drug Delivery Systems Ear Educational workshop Electric Stimulation Electrophysiology (science)Engineering Ensure Frequencies Funding Goals Grant Hair Cells Head and Neck Surgery Hearing Human Implant Implanted Electrodes Industry Inflammation Inpatients Intellectual Property Labyrinth Lead Manufacturer Marketing Measurement Measures Mechanics Modification Music National Institute on Deafness and Other Communication Disorders Neurons Operating Rooms Operative Surgical Procedures Otolaryngology Outcome Patients Phase Population Positioning Attribute Postoperative Period Process Program Development Protocols documentation Publishing Research Research Contracts Residual state Risk Rodent Model Safety Sensorineural Hearing Loss Sensory Hair Speech Perception Sterilization Steroids Structure System Technology Testing Therapeutic Therapeutic Uses Time Trauma Treatment Efficacy Universities Validation biomaterial compatibility clinic ready clinical application clinical translation clinically relevant commercialization design effective therapy experience experimental study hazard hearing preservation implantable device implantation improved manufacture natural hypothermia neural neuroprotection novel patient prognosis pre-clinical pre-clinical research preclinical study preservation programs prototype public health relevance research and development speech in noise standard of care therapy design therapy outcome

项目摘要

Project Summary The goal of our project is to finalize, validate, and prepare for regulatory approvals a device and probe for delivering localized, controlled therapeutic hypothermia to the inner ear. The device safety and efficacy will be tested for residual hearing preservation in cochlear implant surgeries by comparing pre- and post-operative hearing outcomes and intra-operative electrophysiological measurements. Extensive preclinical research was enabled by a NIDCD R21 and industry support that allowed development of a protocol for hypothermia delivery using a device and probe suitable for a rodent model. We propose here to re-engineer the device and probe for clinical implantation in the operating room, and prepare it for regulatory approval. We will also carry out first-in- patient studies for the therapy by implementing localized, therapeutic hypothermia for protection of hair cells and neural substrate during cochlear implantation. This approach brings a non-pharmaceutical therapy for residual hearing preservation to the market. Furthermore, hypothermia localized to the inner ear avoids challenges with systemic cooling or with delivery of drugs to the inner ear. The device and probe do not require alteration of the surgical approach or the implant electrode. The specific aims are motivated by our preclinical studies that have shown that hypothermia can preserve residual hearing long-term post-cochlear implantation. Ensuring the survival of sensitive hair cells and neural structures in the cochlea will lead to improved residual hearing preservation, which in the long-term can improve speech perception outcomes.

项目概要我们项目的目标是最终确定、验证设备和探针并为监管部门批准做好准备向内耳提供局部、受控的治疗性低温。该设备的安全性和有效性将通过比较术前和术后，测试人工耳蜗植入手术中残余听力的保留情况听力结果和术中电生理测量。广泛的临床前研究由 NIDCD R21 和行业支持支持，允许开发低温输送方案使用适合啮齿动物模型的设备和探针。我们在此建议重新设计设备和探针在手术室进行临床植入，并为监管部门批准做好准备。我们还将进行先入为主的患者研究通过实施局部治疗性低温来保护毛细胞和人工耳蜗植入期间的神经基质。这种方法为残余物带来了非药物疗法听力保护市场。此外，仅限于内耳的低温避免了挑战全身冷却或将药物输送至内耳。该设备和探头不需要改变手术方法或植入电极。具体目标是由我们的临床前研究激发的，这些研究已经研究表明，低温可以在人工耳蜗植入后长期保留残余听力。确保耳蜗中敏感毛细胞和神经结构的存活将改善残余听力保存，从长远来看可以改善语音感知结果。