Zenner H P, Maassen M M, Lehner R L, Baumann J W, Leysieffer H
Universitätsklinik für Hals-Nasen-Ohren-Heilkunde, Tübingen.
HNO. 1997 Oct;45(10):872-80. doi: 10.1007/s001060050166.
A microphone constructed for implantation in the posterior wall of the auditory canal and a piezoelectric transducer serving as the main components of an implantable hearing aid were temporally implanted in five patients during middle ear surgery under local anesthesia. The microphone was positioned beneath the skin of the auditory canal such that it completely covered the microphone membrane. The vibratory element of the transducer was coupled to the malleus in four patients with normal ossicular chains and directly to the stapes in one patient with missing incus. The microphone and transducer were electrically connected with an external battery-driven signal amplifier. Speech material and music were presented in the operation room at a sound level of 65 dB SPL under free-field conditions. The patients had to estimate the quality of speech, music, and their own voice as well as the effects of bone-conducting noises. All patients were able to hear with the system. An intraoperative talk without vision contact was possible without any problems, as was understanding of numerals ("Freiburger Zahlentest"). Perception of music was judged as "clear and undistorted with all broadband component." The estimation was also valid for one patient with a sensorineural hearing loss. One patient declared the music to be "a little of unnatural." Bone-conducted sound was estimated as normal in two patients, better than without an implant in one patient with sensorineural hearing loss, and "somewhat metallic" in another patient. Hearing the own voice was considered "normal" in two cases "monotonous" in one case, and "a little bit roaring" in another case. An amplification factor that can be technically realized in an implantable hearing aid was necessary for one of the patients with sensorineural hearing loss to perceive music at a pleasant volume. On the basis of this study, essential requirements for the construction of a fully implantable hearing aid are fulfilled.
一种用于植入耳道后壁的麦克风和一个用作可植入式助听器主要部件的压电换能器，在局部麻醉下的中耳手术期间临时植入了五名患者体内。麦克风置于耳道皮肤下方，使其完全覆盖麦克风膜片。在四名听骨链正常的患者中，换能器的振动元件与锤骨相连，在一名砧骨缺失的患者中则直接与镫骨相连。麦克风和换能器与一个外部电池驱动的信号放大器进行电连接。在手术室的自由场条件下，以65 dB SPL的声级呈现语音材料和音乐。患者必须评估语音、音乐和他们自己声音的质量，以及骨导噪声的影响。所有患者都能用该系统听到声音。术中无需视觉接触的交谈毫无问题，理解数字（“弗莱堡数字测试”）也没问题。对音乐的感知被判定为“所有宽带成分清晰且无失真”。这一评估对一名感音神经性听力损失患者也有效。一名患者称音乐“有点不自然”。两名患者估计骨导声音正常，一名感音神经性听力损失患者认为骨导声音比未植入时更好，另一名患者则认为“有点金属声”。两名患者认为听到自己的声音“正常”，一名患者认为“单调”，另一名患者认为“有点轰鸣”。对于一名感音神经性听力损失患者来说，要以愉悦的音量感知音乐，可植入式助听器在技术上实现的放大倍数是必要的。基于这项研究，完全可植入式助听器构造的基本要求得到了满足。
