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: 10375480
• 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/10375480
• 关键词: 3-Dimensional; Acoustic Nerve; Acoustic Neuroma; Acute; 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; Head; Health; Hearing; Hearing problem; Histologic; Human; Human Volunteers; Impairment; Implant; Inferior Colliculus; Investigation; Iridium; Language; Length; Measures; Metals; Monitor; Music; Names; Nerve; Nerve Fibers; Noise; Operative Surgical Procedures; Pathway interactions; Patients; Performance; Persons; Pitch Perception; Research; Restaurants; Safety; Scala Tympani; 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.项目总结。该项目旨在改善重度和深度失聪患者的听力恢复。 人民。目前恢复听力的护理标准是人工耳蜗(CI)，由16个- 22根金属电极置入耳蜗鼓阶。大多数CI用户可以预期实现 在安静的环境中接受合理的语音。然而，在日常生活中，表现并不令人满意 复杂的听觉场景，包含背景噪音和相互竞争的说话者，如在餐馆和繁忙的地方 办公室和教室。此外，CI用户对逐个周期的时间精细结构的敏感度有限 声音，这是时间音调知觉的基础。音高知觉受损加剧了 在复杂场景中的听力，损害语音识别和对讲话的情感内容的敏感性，限制 音乐欣赏，并降低对普通话和其他声调语言的理解。我们已经在 将穿透性神经内(IN)电极阵列植入麻醉猫的短期研究 耳蜗神经可以克服CI的许多局限性。具体地，IN电极可以选择性地激活 专用于传输颞叶细小信息的低频耳蜗路和脑干通路 结构化信息。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；我们对该装置的工作名称是“CI+1”。CI+1由15个 16通道高级仿生CI的通道与单通道Ir电极相结合，将 穿透耳蜗神经，瞄准低频耳蜗神经纤维。Ir电极是等效的 8-10小腿穿透听觉脑干植入物的一个小腿，已用于FDA批准的 临床试验。具体目标1是测试CI+1在猫身上植入6个月的安全性和有效性， 日常刺激。我们将在2周时测量电诱发听觉脑干反应(Eabr)。 跟踪刺激阈值的任何变化的时间间隔。然后，在一个涉及录音的终端实验中 沿着下丘的正位轴，我们将评估兴奋的传播和传递 由标量内电极和内电极提供的时间信息。具体目标2是评估短期IN 手术切除前庭神经鞘瘤患者的刺激。具体目标3是 应用身体颞骨研究评价CI+1植入的最佳手术入路 骨头。在资助的第五年初期，我们的目标是完成必要的背景研究，并 申请FDA的研究设备豁免，允许将CI+1转换为第一 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 传统CI加上对低频声音的增强敏感度和增强的音调感知。在临床上 对于某些应用，CI+1最初可能会受到青睐，但原则上该设备将是一种 几乎每一位人工耳蜗术患者的首选选择。