Fully implantable hearing aid in the incudostapedial joint gap.

A fully implantable hearing aid is introduced which is a combined sensor-actuator-transducer designed for insertion into the incudostapedial joint gap (ISJ). The active elements each consist of a thin titanium membrane with an applied piezoelectric single crystal. The effectiveness of the operating principle is verified in a temporal bone study. We also take a closer look at the influence of an implantation-induced increase in middle ear stiffness on the transducer's output. An assembly of the transducer with 1 mm thickness is built and inserted into six temporal bones. At this thickness, the stiffness of the annular ligament is considerably increased, which leads to a loss in functional gain for the transducer. It is assumed that a thinner transducer would reduce this effect. In order to examine the performance for a prospective reduced pretension, we increased the gap size at the ISJ by 0.5 mm by removing the capitulum of the stapes in four temporal bones. The TM is stimulated with a broadband multisine sound signal in the audiological frequency range. The movement of the stapes footplate is measured with a laser Doppler vibrometer. The sensor signal is digitally processed and the amplified signal drives the actuator. The resulting feedback is minimized by an active noise control least mean square (LMS) algorithm which is implemented on a field programmable gate array. The dynamic range and the functional gain of the transducer in the temporal bones are determined. The results are compared to measurements from temporal bones without ISJ extension and to the results of Finite Elements Model (FE model) simulations. In the frequency range above 2 kHz a functional gain of 30 dB and more is achieved. This proposes the transducer as a potential treatment for high frequency hearing loss, e.g. for patients with noise-induced hearing loss. The transducer offers sufficient results for a comprehensive application. Adaptations in the transducer design or surgical approach are necessary to cope with ligament stiffening issues. These cause insufficient performance for low frequencies under 1 kHz.