Analysis of design parameters of round-window stimulating type electromagnetic transducer by a nonlinear lumped parameter model of implanted human ear.

Round-window stimulating transducer is a new solution to treat mixed hearing loss. To uncover the factors affecting the round-window stimulation's performance, we investigated the influence of four main design parameters of round-window stimulating type electromagnetic transducer. Firstly, we constructed a human ear nonlinear lumped parameter model and confirmed its validity by comparing the stapes responses predicted by the model with the experimental data. Following this, an electromagnetic transducer's mechanical model, which simulates the floating mass transducer, was built and coupled to the human ear model; thereby, we established a nonlinear lumped parameter model of implanted human ear under round-window stimulation and verified its reliability. Finally, based on this model, the influences of the four main design parameters, i.e., the excitation voltage, the electromechanical coupling coefficient, the support stiffness, and the preload force, were analyzed. The results show that the change of excitation voltage does not alter the system's natural frequency. Chaotic motion occurs when the electromechanical coupling coefficient is small. Meanwhile, the stapes displacement appears to increase firstly and then decrease with the increase of the electromechanical coupling coefficient. The increase of the support stiffness enlarges the resonance frequency of the stapes displacement and reduces the stapes displacement near the resonance frequency, deteriorating the transducer's hearing compensation at low frequency. The preload force can improve the transducer's hearing compensation performance in mid-high frequency region.

Effects of design and coupling parameters on the performance of electromagnetic transducers in round-window stimulation.

Many studies have investigated factors contributing to large variations in the outcomes of round-window (RW) stimulation but most have focused on the floating mass transducer (FMT). To determine whether results for the FMT hold for a fixed-type transducer (FTT), this study constructs two coupled finite element models of the transducer and the human ear that incorporate the cochlear third windows and inner structures of these two electromagnetic transducers. We use these FE models of the human ear and transducers to investigate the influence of four design parameters and coupling conditions for the transducers, i.e., the support's Young's modulus, the coupling layer's cross sectional area and Young's modulus, and the transducer's cross sectional area. The results show that an increase in the support's Young's modulus reduces the output of the FMT but increases that of the FTT. Reducing the cross sectional area and Young's modulus of the coupling layer significantly increases the low-frequency response of the FMT but slightly reduces that of the FTT. Reducing the cross sectional area of the transducer increases the output of the FMT but reduces that of the FTT. This shows that inner structures of electromagnetic transducers should be considered in the optimal design parameters and coupling conditions for RW stimulation.

[Numerical study on the effect of middle ear malformations on energy absorbance].

In order to study the effect of middle ear malformations on energy absorbance, we constructed a mechanical model that can simulate the energy absorbance of the human ear based on our previous human ear finite element model. The validation of this model was confirmed by two sets of experimental data. Based on this model, three common types of middle ear malformations, i. e. incudostapedial joint defect, incus fixation and malleus fixation, and stapes fixation, were simulated by changing the structure and material properties of the corresponding tissue. Then, the effect of these three common types of middle ear malformations on energy absorbance was investigated by comparing the corresponding energy absorbance. The results showed that the incudostapedial joint defect significantly increased the energy absorbance near 1 000 Hz. The incus fixation and malleus fixation dramatically reduced the energy absorbance in the low frequency, which made the energy absorbance less than 10% at frequencies lower than 1 000 Hz. At the same time, the peak of energy absorbance shifted to the higher frequency. These two kinds of middle ear malformations had obvious characteristics in the wideband acoustic immittance test. In contrast, the stapes fixation only reduced the energy absorbance in the low frequency and increased energy absorbance in the middle frequency slightly, which had no obvious characteristic in the wideband acoustic immittance test. These results provide a theoretical reference for the wideband acoustic immittance diagnosis of middle ear malformations in clinic.

Effect of stimulation sites on the performance of electromagnetic middle ear implant: A finite element analysis.

Electromagnetic middle ear implants (MEIs), which use the mechanical vibration of their implanted transducers to treat hearing loss, have emerged to overcome the limitations of conventional hearing aids. Several reports have indicated that the electromagnetic MEI's performance changed with different stimulation sites of the transducer. The aim of this study was to analyze the influence of the transducers' stimulation sites on the electromagnetic MEIs' performance. To aid this investigation, a human ear finite-element model was developed from micro-CT images of an adult's right ear. The validity of the model was confirmed by comparing the model-derived results with experimental data. Then, stimulation forces, which simulate ideal electromagnetic transducers, were respectively applied at five typical coupling sites: the umbo, incus body, incus long process, the round window, and the stapes. The stimulation sites' influence on the electromagnetic MEI's performance was studied by analyzing their corresponding basilar membrane displacements. The results show that stimulation of the round window with a force produces more cochlear stimulation than equal force stimulation of the umbo, incus body, incus long process and the stapes, though the superiority of the round window depends on its smaller area compared to the stapes footplate. Among the forward stimulation, the stapes is the optimal stimulation site for the electromagnetic transducer regarding its hearing compensation's efficiency. The performance of the umbo stimulation is comparable to that of the incus-long-process stimulation. Driving the incus body is less efficient than stimulating the other forward driving sites. Additional, using the stapes response to evaluate the forward stimulation gives results similar to those deduced by the basilar membrane response; in contrast, for the round-window stimulation, the evaluation result based on the stapes response is prominently less than the one calculated by the basilar membrane response, especially in the mid-high frequency range.

[Numerical analysis of the influence of otitis media on the hearing compensation performance of round-window stimulation].

In order to study the influence of tympanic membrane lesion and ossicular erosion caused by otitis media on the hearing compensation performance of round-window stimulation, a human ear finite element model including cochlear asymmetric structure was established by computed tomography (CT) technique and reverse engineering technique. The reliability of the model was verified by comparing with the published experimental data. Based on this model, the tympanic membrane lesion and ossicular erosion caused by otitis media were simulated by changing the corresponding tissue structure. Besides, these simulated diseases' effects on the round-window stimulation were studied by comparing the corresponding basilar-membrane's displacement at the frequency-dependent characteristic position. The results show that the thickening and the hardening of the tympanic membrane mainly deteriorated the hearing compensation performance of round-window stimulation in the low frequency; tympanic membrane perforation and the minor erosion of ossicle with ossicular chain connected slightly effected the hearing compensation performance of round-window stimulation. Whereas, different from the influence of the aforementioned lesions, the ossicular erosion involving the ossicular chain detachment increased its influence on performance of round-window stimulation at the low frequency. Therefore, the effect of otitis media on the hearing compensation performance of round-window stimulation should be considered comprehensively when designing its actuator, especially the low-frequency deterioration caused by the thickening and the hardening of the tympanic membrane; the actuator's low-frequency output should be enhanced accordingly to ensure its postoperative hearing compensation performance.

Influence of middle ear disorder in round-window stimulation using a finite element human ear model.

PURPOSE: The aim of this work was to study the effect of middle ear disorder on round window (RW) stimulation, so as to provide references for the optimal design of RW stimulation type middle ear implants (MEIs). METHODS: A human ear finite-element model was built by reverse engineering technique based on micro-computed tomography scanning images of human temporal bone, and was validated by three sets of comparisons with experimental data. Then, based on this model, typical disorders in otosclerosis and otitis media were simulated. Finally, their influences on the RW stimulation were analyzed by comparison of the displacements of the basilar membrane. RESULTS: For the otosclerosis, the stapedial abnormal bone growth severely deteriorated the equivalent sound pressure of the RW stimulation at higher frequencies, while the hardening of ligaments and tendons prominently decreased the RW stimulation at lower frequencies. Besides, among the hardening of the studied tissues, the influence of the stapedial annular ligament's hardening was much more significant. For the otitis media, the round window membrane (RWM)'s thickening mainly decreased the RW stimulation's performance at lower frequencies. When the elastic modulus' reduction of the RWM was considered at the same time especially for the acute otitis media, it would raise the lower-frequency performance of the RW stimulation. CONCLUSIONS: The influence of the middle ear disorder on the RW stimulation is considerable and variable, it should be considered during the design of the RW stimulation type MEIs.

Numerical Study and Optimization of a Novel Piezoelectric Transducer for a Round-Window Stimulating Type Middle-Ear Implant.

Round window (RW) stimulation is a new application of middle ear implants for treating hearing loss, especially for those with middle ear disease. However, most reports on it are based on the use of the floating mass transducer (FMT), which was not originally designed for round window stimulation. The mismatch of the FMT's diameter and the round window membrane's diameter and the uncontrollable preload of the transducer, leads to a high variability in its clinical outcomes. Accordingly, a new piezoelectric transducer for the round-window-stimulating-type middle ear implant is proposed in this paper. The transducer consists of a piezoelectric stack, a flextensional amplifier, a coupling rod, a salver, a plate, a titanium housing and a supporting spring. Based on a constructed coupling finite element model of the human ear and the transducer, the influences of the transducer design parameters on its performance were analyzed. The optimal structure of the supporting spring, which determines the transducer's resonance frequency, was ascertained. The results demonstrate that our designed transducer generates better output than the FMT, especially at low frequency. Besides this, the power consumption of the transducer was significantly decreased compared with a recently reported RW-stimulating piezoelectric transducer.

Concept and Evaluation of a New Piezoelectric Transducer for an Implantable Middle Ear Hearing Device.

Implantable middle ear hearing devices (IMEHDs) have been developed as a new technology to overcome the limitations of conventional hearing aids. The piezoelectric cantilever transducers currently used in the IMEHDs have the advantages of low power consumption and ease of fabrication, but generate less high-frequency output. To address this problem, we proposed and designed a new piezoelectric transducer based on a piezoelectric stack for the IMEHD. This new transducer, attached to the incus body with a coupling rod, stimulates the ossicular chain in response to the expansion-and-contraction of its piezoelectric stack. To test its feasibility for hearing loss compensation, a bench testing of the transducer prototype and a temporal bone experiment were conducted, respectively. Bench testing results showed that the new transducer did have a broad frequency bandwidth. Besides, the transducer was found to have a low total harmonic distortion (<0.75%) in all frequencies, and small release time (1 ms). The temporal bone experiment further proved that the transducer has the capability to produce sufficient vibrations to compensate for severe sensorineural hearing loss, especially at high frequencies. This property benefits the treatment of the most common sloping high-frequency sensorineural hearing loss. To produce a 100 dB SPL equivalent sound pressure at 1 kHz, its power consumption is 0.49 mW, which is low enough for the transducer to be utilized in the IMEHD.

Analysis of the influence of the transducer and its coupling layer on round window stimulation.

PURPOSE: In this work, a finite element study is proposed to evaluate the effects of the transducer and its coupling layer on the performance of round window (RW) stimulation. METHODS: Based on a set of micro-computer tomography images of a healthy adult's right ear and reverse engineering technique, a coupled finite-element model of the human ear and the transducer was constructed and verified. Then, the effect of the cross-section of the transducer, the elastic modulus of the coupling layer, the mass of the transducer, and the preload of the transducer were studied. RESULTS: The increase of the transducer's cross-section area deteriorates the RW stimulation, especially at the lower frequencies. This adverse effect of the cross-section area's increase of the transducer can be reduced by adding a coupling layer between the transducer and the RW. However, the coupling layer's improvement on the RW stimulation is reduced with the increase of its elastic modulus. Moreover, the mass loading of the transducer decreases the RW stimulation's performance mainly at higher frequencies and applying a static preload on the transducer enhances its hearing compensating performance at higher frequencies. CONCLUSIONS: The influence of the transducer's mass, the mass of the transducer, the applied static preload and the properties of the coupling layer must be taken into account in the design of the RW stimulation type implantable middle ear hearing device.

Evaluation of Round Window Stimulation Performance in Otosclerosis Using Finite Element Modeling.

Round window (RW) stimulation is a new type of middle ear implant's application for treating patients with middle ear disease, such as otosclerosis. However, clinical outcomes show a substantial degree of variability. One source of variability is the variation in the material properties of the ear components caused by the disease. To investigate the influence of the otosclerosis on the performance of the RW stimulation, a human ear finite element model including middle ear and cochlea was established based on a set of microcomputerized tomography section images of a human temporal bone. Three characteristic changes of the otosclerosis in the auditory system were simulated in the FE model: stapedial annular ligament stiffness enlargement, stapedial abnormal bone growth, and partial fixation of the malleus. The FE model was verified by comparing the model-predicted results with published experimental measurements. The equivalent sound pressure (ESP) of RW stimulation was calculated via comparing the differential intracochlear pressure produced by the RW stimulation and the normal eardrum sound stimulation. The results show that the increase of stapedial annular ligament and partial fixation of the malleus decreases RW stimulation's ESP prominently at lower frequencies. In contrast, the stapedial abnormal bone growth deteriorates RW stimulation's ESP severely at higher frequencies.