Reinfeldt Sabine, Håkansson Bo, Taghavi Hamidreza, Eeg-Olofsson Måns
Department of Signals and Systems, Chalmers University of Technology, Gothenburg, Sweden.
Department of Otorhinolaryngology, Head and Neck Surgery, Sahlgrenska University Hospital, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Med Devices (Auckl). 2015 Jan 16;8:79-93. doi: 10.2147/MDER.S39691. eCollection 2015.
The different kinds of bone-conduction devices (BCDs) available for hearing rehabilitation are growing. In this paper, all BCDs currently available or in clinical trials will be described in categories according to their principles. BCDs that vibrate the bone via the skin are referred to as skin-drive devices, and are divided into conventional devices, which are attached with softbands, for example, and passive transcutaneous devices, which have implanted magnets. BCDs that directly stimulate the bone are referred to as direct-drive devices, and are further divided into percutaneous and active transcutaneous devices; the latter have implanted transducers directly stimulating the bone under intact skin. The percutaneous direct-drive device is known as a bone-anchored hearing aid, which is the BCD that has the largest part of the market today. Because of some issues associated with the percutaneous implant, and to some extent because of esthetics, more transcutaneous solutions with intact skin are being developed today, both in the skin-drive and in the direct-drive category. Challenges in developing transcutaneous BCDs are mostly to do with power, attachment, invasiveness, and magnetic resonance imaging compatibility. In the future, the authors assume that the existing percutaneous direct-drive BCD will be retained as an important rehabilitation alternative, while the transcutaneous solutions will increase their part of the market, especially for patients with bone-conduction thresholds better than 35 dB HL (hearing level). Furthermore, the active transcutaneous direct-drive BCDs appear to be the most promising systems, but to establish more detailed inclusion criteria, and potential benefits and drawbacks, more extensive clinical studies are needed.
可用于听力康复的不同类型骨传导装置（BCD）正在不断增加。在本文中，目前可用或处于临床试验阶段的所有BCD将根据其原理进行分类描述。通过皮肤使骨骼振动的BCD被称为皮肤驱动装置，可分为常规装置（例如通过软带佩戴的装置）和被动经皮装置（带有植入磁铁）。直接刺激骨骼的BCD被称为直接驱动装置，进一步分为经皮装置和有源经皮装置；后者的植入式换能器可在完整皮肤下直接刺激骨骼。经皮直接驱动装置即骨锚式助听器，是目前市场份额最大的BCD。由于与经皮植入相关的一些问题，以及在一定程度上出于美观考虑，如今在皮肤驱动和直接驱动类别中都在开发更多具有完整皮肤的经皮解决方案。开发经皮BCD的挑战主要与功率、附着、侵入性和磁共振成像兼容性有关。作者预计，未来现有的经皮直接驱动BCD仍将作为重要的康复选择保留，而经皮解决方案将增加其市场份额，特别是对于骨传导阈值优于35 dB HL（听力水平）的患者。此外，有源经皮直接驱动BCD似乎是最有前景的系统，但要确定更详细的纳入标准以及潜在的益处和缺点，还需要更广泛的临床研究。
