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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：
10362716
负责人：
Curtis Scott King
金额：
$ 76.78万
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/10362716
关键词：
Acoustic Stimulation Acoustics Address Adult Americas Audiology Blood Vessels Cadaver Clinical Clinical Engineering Cochlea Cochlear Implants Cochlear implant procedure Collaborations Coupled Data 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 Intellectual Property Labyrinth Lead Manufacturer Name 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 base biomaterial compatibility clinical application clinical translation clinically relevant commercialization design effective therapy experience experimental study hazard hearing preservation implantable device implantation improved natural hypothermia neuroprotection novel patient prognosis patient safety pre-clinical pre-clinical research preclinical study preservation programs prototype public health relevance relating to nervous system 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.

项目总结