Consisting of the actuator and coupling layer, a finite element model of the human middle ear was used to analyze the effect of the actuator and its coupling conditions on the performance of the eardrum-stimulated middle ear implants. This model which was based on the right ear of a healthy adult was built via microcomputed tomography imaging and the technique of reverse engineering. Based on this finite element model, the linear viscoelasticity of the human middle ear soft tissues and three-layer structure of the eardrum pars tensa which was orthotropic were considered. The validity of the model was verified by comparing the model calculated results with experimental data. After that, the influence of the three main design parameters of the actuator and two aspects of the coupling layer were investigated by the finite element model. The results show that (1) the manubrium tip is the optimal position for the actuator to stimulate; (2) the increased cross-section of the actuator would worsen its hearing compensation performance, especially in the low frequencies; (3) both the patients’ residual hearing and the actuator’s hearing compensation performance at high frequencies will be deteriorated with the increase in the actuator’s mass; and (4) a coupling layer with a small Young’s modulus and an area approximating 80% of the eardrum would reduce the stress of the eardrum effectively.
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