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.

项目摘要我们项目的目的是确定，验证和准备监管机构批准的设备并进行调查将局部受控的治疗性体温过低输送到内耳。设备的安全性和功效将是通过比较术前和术后，测试了人工耳蜗手术中的残留听力保存听力结果和术中电生理测量。广泛的临床前研究是由NIDCD R21和行业支持启用，允许开发用于体温过低的协议使用适合啮齿动物模型的设备和探测器。我们在这里建议重新设计设备，并探测在手术室中临床植入，并准备好监管批准。我们还将进行第一通过实施局部治疗性体温过低来保护毛细胞和人工耳蜗期间的神经底物。这种方法带来了用于残留的非药物治疗向市场听力保存。此外，定位于内耳的体温过低避免了挑战全身冷却或将药物输送到内耳。设备和探针不需要改变手术方法或植入电极。具体目的是由我们的临床前研究激发的表明体温过低可以保留剩余的听力长期脑化后植入。确保耳蜗中敏感的毛细胞和神经结构的存活将导致剩余的听力改善保存，从长远来看可以改善语音感知结果。