Medical Device Department, Helbling Technik BernAG, CH-3097 Liebefeld, Switzerland.
IEEE Trans Biomed Eng. 2011 Feb;58(2):420-8. doi: 10.1109/TBME.2010.2087756. Epub 2010 Oct 18.
A new hearing therapy based on direct acoustic cochlear stimulation was developed for the treatment of severe to profound mixed hearing loss. The device efficacy was validated in an initial clinical trial with four patients. This semi-implantable investigational device consists of an externally worn audio processor, a percutaneous connector, and an implantable microactuator. The actuator is placed in the mastoid bone, right behind the external auditory canal. It generates vibrations that are directly coupled to the inner ear fluids and that, therefore, bypass the external and the middle ear. The system is able to provide an equivalent sound pressure level of 125 dB over the frequency range between 125 and 8000 Hz. The hermetically sealed actuator is designed to provide maximal output power by keeping its dimensions small enough to enable implantation. A network model is used to simulate the dynamic characteristics of the actuator to adjust its transfer function to the characteristics of the middle ear. The geometry of the different actuator components is optimized using finite-element modeling.
一种基于直接声 Cochlear 刺激的新型听力治疗方法已被开发用于治疗严重至重度混合性听力损失。该设备的疗效已在一项包含四名患者的初步临床试验中得到验证。该半植入式研究设备由外部佩戴的音频处理器、经皮连接器和可植入微致动器组成。致动器放置在乳突骨中，刚好在外耳道后面。它产生的振动直接耦合到内耳液中，从而绕过外耳和中耳。该系统能够在 125 至 8000 Hz 的频率范围内提供 125 dB 的等效声压级。密封的致动器通过保持足够小的尺寸以实现植入来设计提供最大输出功率。网络模型用于模拟致动器的动态特性，以调整其传递函数以适应中耳的特性。使用有限元建模对不同致动器组件的几何形状进行了优化。
