A full-custom fully implantable cochlear implant system validated in vivo with an animal model

Hasan Uluşan, M. Berat Yüksel, Özlem Topçu, H. Andaç Yiğit, Akın M. Yılmaz, Mert Doğan, Nagihan Gülhan Yasar, İbrahim Kuyumcu, Aykan Batu, Nebil Göksu, M. Birol Uğur, Haluk Külah
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Abstract

Realizations of fully implantable cochlear implants (FICIs) for providing adequate solution to esthetic concerns and frequent battery replacement have lacked of addressing system level criteria as a complete device. Here, we present a full-custom FICI that considers design of both an implantable sensor for wide range sound sensing and a signal conditioning circuit for electrical stimulation of the auditory nerve. The microelectromechanical system (MEMS)-based acoustic sensor utilizes multiple cantilever beam structures to sense and filter the mechanical vibrations on the ossicular chain. The area optimized bilayer design of the piezoelectric sensor met with the volume limitation in the middle ear while achieving high signal-to-noise-ratio. The sensor outputs are processed by a current mode low-power signal conditioning circuit that stimulates the auditory neurons through intracochlear electrodes. The FICI is validated with an in vivo model where the electrical auditory brainstem response (eABR) of the animal was observed while applying sound excitation. The eABR results demonstrate that the system is able to evoke responses in the auditory nerves of a guinea pig for sound range of 45–100 dB SPL within the selected frequency bands. Dr Ulusan and colleagues design a fully implantable cochlear implant and demonstrate functionality using an in vivo model where sound vibrations within a range of 45–100 dB SPL can be detected and filtered. The design uses a MEMS-based acoustic sensor coupled with a low-power signal-conditioning circuit that will also ensure long operating times.

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通过动物模型在体内验证的全定制全植入式人工耳蜗系统
全植入式人工耳蜗(FICI)可充分解决美观问题和频繁更换电池的问题,但作为一个完整的设备,它缺乏系统级标准。在这里,我们介绍一种全定制 FICI,它既考虑了用于大范围声音感应的植入式传感器的设计,也考虑了用于电刺激听觉神经的信号调节电路的设计。基于微机电系统(MEMS)的声学传感器利用多个悬臂梁结构来感应和过滤听骨链上的机械振动。压电传感器的面积优化双层设计既能满足中耳的体积限制,又能实现高信噪比。传感器输出由电流模式低功耗信号调节电路处理,该电路通过耳蜗内电极刺激听觉神经元。FICI 通过活体模型进行了验证,在该模型中,在施加声音激励的同时观察了动物的听性脑干电反应(eABR)。电听觉脑干反应结果表明,该系统能够在选定频段内唤起豚鼠听觉神经对 45-100 dB SPL 范围内声音的反应。Ulusan 博士及其同事设计了一种完全可植入的人工耳蜗,并使用体内模型演示了其功能,在该模型中,可以检测和过滤 45-100 dB SPL 范围内的声音振动。该设计采用了基于 MEMS 的声学传感器和低功耗信号调节电路,可确保长时间工作。
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