Enhanced auditory prosthesis using a penetrating auditory-nerve electrode

使用穿透性听觉神经电极的增强型听觉假体

• 批准号: 10599903
• 负责人: Harrison William Lin
• 金额: $ 32.83万
• 依托单位: UNIVERSITY OF CALIFORNIA-IRVINE
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-11 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10599903
• 关键词: 3-Dimensional; Acoustic Nerve; Acoustic Neuroma; Acute; Anesthesia procedures; Animal Experiments; Animal Model; Animals; Apical; Artificial Implants; Auditory; Auditory Brain Stem Implants; Auditory Brainstem Responses; Auditory Prosthesis; Bionics; Brain Stem; Cadaver; Cell Nucleus; Chronic; Clinical Trials; Cochlea; Cochlear Implants; Cochlear Nerve; Cochlear implant procedure; Complex; Contralateral; Devices; Electric Stimulation; Electrodes; Emotional; Environment; Excision; Experimental Designs; FDA approved; Fascicle; Felis catus; Fiber; Frequencies; Funding; Growth; Health; Hearing; Hearing problem; Histologic; Human; Human Volunteers; Impairment; Implant; Inferior Colliculus; Iridium; Language; Length; Measures; Metals; Monitor; Music; Names; Nerve; Nerve Fibers; Noise; Operative Surgical Procedures; Pathway interactions; Patients; Penetration; Performance; Persons; Pitch Perception; Research; Resected; Restaurants; Safety; Scala Tympani; Sedation procedure; Speech; Structure; System; Temporal bone structure; Testing; Translating; Translations; X-Ray Computed Tomography; auditory pathway; clinical application; deaf; experimental study; feasibility testing; hearing impairment; hearing restoration; implantation; improved; lexical; novel; programs; reconstruction; safety testing; sound; sound frequency; speech recognition; standard of care; transmission process; tumor; voice recognition

1. Project Summary. This project aims to improve hearing restoration for severely and profoundly deaf people. The present-day standard of care for restoration of hearing is a cochlear implant (CI), consisting of 16- 22 metal electrodes inserted into the scala tympani of the cochlea. Most CI users can expect to achieve reasonable speech reception in quiet environments. Performance is unsatisfactory, however, in everyday complex auditory scenes containing background noise and competing talkers, as in restaurants and in busy offices and classrooms. Also, CI users have only limited sensitivity to cycle-by-cycle temporal fine structure of sounds, which underlies temporal pitch perception. The impaired pitch perception exacerbates the problems of hearing in complex scenes, impairs voice recognition and sensitivity to the emotional content of speech, limits music appreciation, and degrades understanding of Mandarin and other tonal languages. We have shown in short-term studies in anesthetized cats that a penetrating intraneural (IN) electrode array inserted into the cochlear nerve can overcome many limitations of a CI. In particular, an IN electrode can selectively activate low-frequency cochlear and brainstem pathways that are specialized for transmission of temporal fine structure information. We now wish to translate IN stimulation to human trials. Specifically, we propose to test the feasibility of an implanted prosthesis; our working name for the device is “CI+1”. The CI+1 consists of 15 channels of a 16-channel Advanced Bionics CI combined with a single-channel iridium electrode that will penetrate the cochlear nerve to target low-frequency cochlear nerve fibers. The iridium electrode is equivalent to one shank of the 8-10 shank penetrating auditory brainstem implant that has been used in FDA-approved clinical trials. Specific Aim 1 is to test the safety and efficacy of 6-month implantations of the CI+ 1 in cats, with daily stimulation. We will measure the electrically evoked auditory brainstem response (eABR) at 2-wk intervals to track any changes in stimulation threshold. Then, in a terminal experiment involving recordings along the tonotopic axis of the inferior colliculus, we will assess spread of excitation and transmission of temporal information by the intrascalar and IN electrodes. Specific Aim 2 is to evaluate short-term IN stimulation in human patients who are undergoing surgery to resect vestibular schwannomas. Specific Aim 3 is to evaluate optimal surgical approaches for CI+1 implantation using studies of cadaveric human temporal bones. Early in the 5th year of funding, we aim to have completed the necessary background studies and to apply for an investigational device exemption from the FDA that will permit translation of the CI+1 to the first human trials. We anticipate that the CI+1 will offer the first human volunteers essentially all the benefits of a conventional CI plus enhanced sensitivity to low-frequency sounds and enhanced pitch perception. In clinical applications, the CI+1 might initially be favored for certain applications, but in principle the device would be a preferred alternative for nearly every candidate for cochlear implantation.

1.项目摘要。该项目旨在改善重度和极重度耳聋者的听力恢复 人目前用于恢复听力的护理标准是人工耳蜗植入物（CI），其由16- 20个电极组成。 22个金属电极插入耳蜗的鼓阶。大多数CI用户可以期望实现 在安静的环境中进行合理的语音接收。然而，在日常生活中， 复杂的听觉场景，包含背景噪音和竞争的谈话者，如在餐馆和忙碌的环境中 办公室和教室。此外，CI用户仅具有有限的敏感性，以周期的时间精细结构， 声音，这是时间音高感知的基础。受损的音高感知加剧了 在复杂场景中的听力，损害语音识别和对语音情感内容的敏感性， 音乐欣赏，并降低普通话和其他音调语言的理解。我们已经展示了在 在麻醉猫的短期研究中，将穿透性神经内（IN）电极阵列插入到 耳蜗神经可以克服CI的许多局限性。特别地，IN电极可以选择性地激活 低频耳蜗和脑干通路，专门用于传输颞叶精细信号 结构信息。我们现在希望将IN刺激转化为人体试验。具体来说，我们建议测试 植入假体的可行性;我们对该器械的工作名称是“CI+1”。CI+1包括15个 16通道Advanced Bionics CI的通道与单通道铱电极组合， 穿透耳蜗神经以靶向低频耳蜗神经纤维。铱电极等同于 8-10柄穿透听觉脑干植入物中的一个柄， 临床试验具体目标1是测试猫中CI+ 1的6个月预防的安全性和有效性， 日常刺激在第2周测定电诱发听性脑干反应（eABR） 间隔以跟踪刺激阈值的任何变化。然后，在一个终端实验中， 沿着下丘的音调轴，我们将评估兴奋的传播和 时间信息由内calar和IN电极。具体目标2是评估短期IN 刺激正在接受手术切除前庭神经鞘瘤的人类患者。具体目标3是 使用尸体人颞叶研究评价CI+1植入的最佳手术入路 骨头我们的目标是在第五个拨款年度初完成所需的背景研究， 向FDA申请试验用器械豁免，允许将CI+1翻译为第一个 人体试验我们预计，CI+1将为第一批人类志愿者提供基本上所有的好处， 传统的CI加上对低频声音的增强的灵敏度和增强的音高感知。临床 在某些应用中，CI+1最初可能有利于某些应用，但原则上，该设备将是一个 几乎所有人工耳蜗植入候选人的首选选择。