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. 项目概要 该项目旨在改善重度和极重度聋人的听力恢复。 目前恢复听力的标准护理是人工耳蜗 (CI)，由 16- 将 22 个金属电极插入耳蜗的鼓阶，大多数 CI 用户都可以实现这一目标。 但在安静环境下的语音接收效果却不尽如人意。 复杂的听觉场景，包含背景噪音和相互竞争的谈话者，例如在餐馆和繁忙的地方 此外，CI 用户对逐周期时间精细结构的敏感度有限。 声音，它是时间音高感知的基础，受损的音高感知使问题变得更加严重。 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，限制 音乐欣赏，并降低对普通话和其他声调语言的理解。 对麻醉猫进行的短期研究，将穿透性神经内 (IN) 电极阵列插入猫的猫 耳蜗神经可以克服 CI 的许多局限性，特别是 IN 电极可以选择性激活。 专门用于传输颞细信号的低频耳蜗和脑干通路 我们现在希望将 IN 刺激转化为人体试验。 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 组成。 16 通道 Advanced Bionics CI 的通道与单通道铱电极相结合，将 穿透耳蜗神经，瞄准低频耳蜗神经纤维。铱电极是等效的。 至已用于 FDA 批准的 8-10 柄穿透性听觉脑干植入物的一根柄 临床试验的具体目标 1 是测试 CI+ 1 在猫中植入 6 个月的安全性和有效性。 我们将在 2 周时测量电诱发听觉脑干反应 (eABR)。 然后，在涉及录音的终端实验中，跟踪刺激阈值的任何变化。 沿着下丘的音调轴，我们将评估兴奋的传播和传输 标量内电极和 IN 电极的时间信息具体目标 2 是评估短期 IN。 对接受前庭神经鞘瘤切除手术的人类患者的刺激具体目标 3 是。 利用尸体人类颞叶研究评估 CI+1 植入的最佳手术方法 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 向 FDA 申请研究器械豁免，允许将 CI+1 转换为第一个 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 CI 加上增强对低频声音的敏感性和增强的音高感知在临床中。 对于某些应用，CI+1 最初可能会受到某些应用的青睐，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替代方案。