Maniglia A J, Ko W H, Garverick S L, Abbass H, Kane M, Rosenbaum M, Murray G
Department of Otolaryngology-Head and Neck Surgery, Case Western Reserve University School of Medicine, University Hospitals of Cleveland, Ohio, USA.
Ear Nose Throat J. 1997 May;76(5):333-8, 340-1.
A semi-implantable middle ear electromagnetic hearing device (SIMEHD) is proposed for limited clinical trial in adult patients to evaluate the implantable hearing device for moderate to severe sensorineural hearing loss. Food and Drug Administration (FDA) investigational device exemption (IDE) approval has been granted (May 1996) for clinical trials. The implant unit has been evaluated acutely and chronically in animals (cats) with excellent results. Five cats undergoing chronic implantation were allowed to survive an average of 9.6 months, showing that the SIMEHD is biocompatible, functional and without untoward complications. All implant units recovered from the cats were functional, except for wire breakage of the internal antenna. A new antenna was redesigned for human implantation. The SIMEHD system consists of an external and internal unit. The external unit consists of a microphone, audio amplifier, modulator, radio frequency (RF) amplifier, antenna and battery. The internal unit is composed of a receiving antenna, hybrid electronic circuit, air core driving coil, and a target magnet cemented to the incus. All materials in contact with the body are biocompatible and expected to survive indefinitely. The implant unit is miniaturized and manufactured with existing fabrication technology by our industrial collaborator, Wilson Greatbatch, Ltd. The specific aims and major tasks of the proposed research are: a) to evaluate reliability, safety and efficacy of the SIMEHD system in a selected group of patients diagnosed with sensorineural hearing loss, due mainly to presbycusis or aging of the inner ear; and b) to obtain objective and subjective evaluation of audiologic and psychoacoustic performance as compared to the acoustic hearing aid. This paper describes the design, illustrates the actual device (newest prototype) and details the technique for surgical implantation in the attic and mastoid antrum in humans.
一种半植入式中耳电磁听力装置（SIMEHD）被提出用于成年患者的有限临床试验，以评估该植入式听力装置对中度至重度感音神经性听力损失的效果。美国食品药品监督管理局（FDA）已批准（1996年5月）该装置进行临床试验的研究性器械豁免（IDE）。该植入单元已在动物（猫）身上进行了急性和慢性评估，结果良好。五只接受慢性植入的猫平均存活了9.6个月，表明SIMEHD具有生物相容性、功能良好且无不良并发症。从猫身上回收的所有植入单元均功能正常，除了内部天线的导线断裂。已重新设计了一种新天线用于人体植入。SIMEHD系统由外部单元和内部单元组成。外部单元包括麦克风、音频放大器、调制器、射频（RF）放大器、天线和电池。内部单元由接收天线、混合电子电路、空心驱动线圈以及粘结在砧骨上的目标磁体组成。所有与身体接触的材料均具有生物相容性，预计可无限期留存。植入单元已由我们的工业合作伙伴威尔逊·格雷特巴奇有限公司（Wilson Greatbatch, Ltd.）采用现有制造技术进行了小型化制造。拟开展研究的具体目标和主要任务是：a）在一组主要因老年性耳聋或内耳老化而被诊断为感音神经性听力损失的患者中评估SIMEHD系统的可靠性、安全性和有效性；b）与声学助听器相比，获得对听力和心理声学性能的客观和主观评估。本文描述了该装置的设计，展示了实际设备（最新原型），并详细介绍了在人体上鼓室和乳突窦进行手术植入的技术。
