Medical Devices: Evidence and Research (Jan 2015)
New developments in bone-conduction hearing implants: a review
Abstract
Sabine Reinfeldt,1 Bo Håkansson,1 Hamidreza Taghavi,1 Måns Eeg-Olofsson21Department of Signals and Systems, Chalmers University of Technology, Gothenburg, Sweden; 2Department of Otorhinolaryngology, Head and Neck Surgery, Sahlgrenska University Hospital, Sahlgrenska Academy, University of Gothenburg, Gothenburg, SwedenAbstract: 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.Keywords: bone-conduction device, implantable, transcutaneous, percutaneous, active, passive