Noninvasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss

无创系统提供低温治疗以防止噪音引起的听力损失

• 批准号: 10081624
• 负责人: Curtis Scott King
• 金额: $ 21.88万
• 依托单位: RESTOREAR DEVICES, LLC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-05 至 2022-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10081624
• 关键词: 3-Dimensional; Adult; Adverse effects; American; Auditory; Biology; Cadaver; Calibration; Catheters; Cells; Centers for Disease Control and Prevention (U.S.); Clinic; Clinical; Clinical Trials; Cochlea; Cochlear Nerve; Computer Models; Data; Development; Device or Instrument Development; Devices; Documentation; Ear; Elements; Ensure; Exposure to; Future; Geometry; Hair Cells; Health; Health Care Costs; Healthcare Systems; Hearing; Heart Arrest; High Prevalence; Human; Human Resources; Impairment; Injury; Investigation; Labyrinth; Legal patent; Licensing; Loudness; Magnetic Resonance Imaging; Manufacturer Name; Measurement; Measures; Mechanics; Medical; Medical Device; Methods; Military Personnel; Mission; Modeling; Neurological outcome; Noise; Noise-Induced Hearing Loss; Occupational; Occupational Noise; Otologic Surgical Procedures; Outcome; Performance; Personal Satisfaction; Persons; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacology; Phase; Preservation Technique; Prevalence; Property; Protocols documentation; Public Health; Publishing; Quality of life; Reporting; Research; Research Personnel; Residual state; Rewarming; Risk; Safety; Savings; Sensory; Sensory Hair; Services; Small Business Innovation Research Grant; Structure; Synapses; System; Technology; Teenagers; Temperature; Temporal bone structure; Temporary Threshold Shift; Testing; Therapeutic; Time; Tissues; Translating; Translations; Trauma; Traumatic Brain Injury; Treatment Cost; United States; United States Food and Drug Administration; Validation; Veterans; Work; base; blood perfusion; clinical practice; cold temperature; cost; design; disability; dosage; early phase clinical trial; efficacy evaluation; efficacy testing; engineering design; experience; hearing impairment; hearing preservation; human subject; improved; in vivo; innovation; life time cost; member; microCT; middle ear; natural hypothermia; neuroprotection; non-invasive system; ototoxicity; phase 1 study; preclinical trial; preservation; prevent; product development; productivity loss; prototype; public health relevance; relating to nervous system; round window; service member; sound; spiral ganglion

Project Summary Noise-induced hearing loss (NIHL) is global public health risk and is an impairment resulting from irreversible damage caused to the sensitive structures and neural elements in the cochlea. A Center for Disease Control and Prevention report highlights that 24% of adults and 17% of teenagers in the United States experience hearing loss in one or both ears from exposure to occupational or recreational loud sound. NIHL has a high prevalence among members of the armed forces and is a serious public health concern associated with loss of productivity, and high health care costs. Globally, occupational noise exposure is responsible for 16% of disabling hearing loss (over 600 million people); with significant lifetime costs per person in the US alone. While several pharmacological agents have shown promising results in preclinical trials and/or entered early clinical trials, at present there is no clinically available strategy to reduce or prevent NIHL. Preliminary and prior published results show that controlled and localized therapeutic hypothermia provided to the inner ear post-NIHL or post- mechanical trauma conserves significant residual hearing and preserves sensitive neural structures. The benefits of therapeutic hypothermia have long been discussed for improved neurological outcomes following traumatic brain injuries and cardiac arrest. This Phase I SBIR proposal will be used to design, build and test systems and protocols to deliver mild therapeutic hypothermia non-invasively to the inner ear during the critical time window following noise trauma. Using computational models of heat transfer and studies from cadaveric temporal bones, this study aims to translate such devices to clinical practice. Successful completion of these Phase I studies will enable Restor-Ear Devices LLC to submit a q-sub for an investigational device exemption (IDE) to the Food and Drug Administration and a future Phase II SBIR application to test efficacy and safety of therapeutic hypothermia against NIHL in human subjects. Considering that the prevalence of hearing loss is expected to increase significantly in the next few decades, these studies will be a first step toward establishing therapeutic hypothermia as a technique for preservation of hearing. It is likely that our systems will find further applications for protecting auditory and vestibular functions against ototoxic insults, traumatic brain injuries, blast exposures, and inner ear or middle ear surgeries.

项目摘要 噪声性听力损失（NIHL）是一种全球性的公共卫生风险，是由不可逆的 对耳蜗中的敏感结构和神经元件造成的损害。美国疾病控制中心 一份报告指出，在美国，24%的成年人和17%的青少年经历过听力障碍。 由于暴露在职业或娱乐性的大声噪音中而导致一只或两只耳朵丧失功能。NIHL的患病率很高 在武装部队成员中，是一个严重的公共卫生问题，与生产力的损失有关， 以及高昂的医疗费用。在全球范围内，职业性噪声暴露导致16%的听力残疾 损失（超过6亿人）;仅在美国，人均终身成本就很高。虽然若干 药理学试剂在临床前试验中显示出有希望的结果和/或进入早期临床试验， 目前临床上还没有减少或预防NIHL的有效策略。初步和先前发表的结果 显示了在NIHL后或NIHL后向内耳提供受控的和局部的治疗性低温， 机械创伤保留了显著的残余听力并保留了敏感的神经结构。的 长期以来，人们一直在讨论低温治疗对改善神经系统结局的好处， 创伤性脑损伤和心脏骤停第一阶段SBIR提案将用于设计、建造和测试 用于在关键的听力损伤期间非侵入性地向内耳递送轻度治疗性低温的系统和方案， 噪声损伤后的时间窗。使用传热计算模型和尸体研究 颞骨，这项研究的目的是将这种设备转化为临床实践。成功完成这些 I期研究将使Restor-Ear Devices LLC能够提交研究器械豁免的Q-申请 (IDE)美国食品和药物管理局和未来的第二阶段SBIR应用，以测试的有效性和安全性 在人类受试者中针对NIHL的治疗性低温。考虑到听力损失的患病率是 预计在未来几十年内将显著增加，这些研究将是建立 低温疗法是一种保护听力的技术。我们的系统很可能会发现 用于保护听觉和前庭功能免受耳毒性损伤、创伤性脑损伤、冲击波 暴露和内耳或中耳手术。