Comparative study of efficiency and characteristics of FMT and DRT installed in human cadavers for round-window stimulation.

Acoustic hearing aids generate amplified sound in the ear canal, and they are the standard of care for patients with mild to moderate sensorineural hearing loss. However, because of their limited frequency bandwidth, gain, and feedback, there is substantial room for improvement. Active middle ear implants, which directly vibrate the middle ear and cochlea, are an alternative approach to conventional acoustic hearing aids. They provide an opportunity to improve sound quality and speech understanding with amplification rehabilitation. For floating-mass type and direct-rod type (DRT) middle ear transducers, a differential floating-mass transducer (DFMT) and a tri-coil bellows transducer (TCBT), respectively, were fabricated to measure the output characteristics in four human temporal bones. Both were fabricated to have similar output forces per unit input and were placed in four human temporal bones to measure their output performances. The TCBT resulted in higher output than did the DFMT throughout the audible frequency range, and the output was more prominent at lower frequency ranges. In this study, we showed that DRT was a more effective method for round window stimulation. Because of its frequency characteristics and vibration efficiency, this implantation method can be utilized as a driving solution for middle ear implants.

A New Type of Wireless Transmission Based on Digital Direct Modulation for Use in Partially Implantable Hearing Aids.

In this study, we developed a new type of wireless transmission system for use in partially implantable hearing aids. This system was designed for miniaturization and low distortion, and features direct digital modulation. The sigma-delta output, which has a high SNR due to oversampling and noise shaping technology, is used as the data signal and is transmitted using a wireless transmission system to the implant unit through OOK without restoration as an audio signal, thus eliminating the need for additional circuits (i.e., LPF and a reference voltage supply circuit) and improving the ease of implantation and reliability of the circuit. We selected a carrier frequency of 27 MHz after analysis of carrier attenuation by human tissue, and designed the communication coil with reference to both the geometry and required communication distance. Circuit design and simulation for wireless transmission were performed using Multisim 13.0. The system was fabricated based on the circuit design; the size of the device board was 13 mm × 13 mm, the size of the implanted part was 9 mm × 9 mm, the diameter of the transmitting/receiving coil was 26 mm, and the thicknesses of these coils were 0.5 and 0.3 mm, respectively. The difference (error) between the detected and simulation waveforms was about 5%, and was thought to be due to the tolerances of the fabricated communication coil and elements (resistors, capacitors, etc.) used in the circuit configuration of the system. The number of windings was reduced more than 9-fold compared to the communication coil described by Taghavi et al. The measured THD was <1% in the frequency band from 100 Hz to 10 kHz, thus easily meeting the standard specification for hearing aids.

The design of a lumped parameter model considering the stimulus path of round window.

BACKGROUND: Sound normally enters the ear canal, passes through the middle ear, and stimulates the cochlea through the oval window. Alternatively, the cochlea can be stimulated in a reverse manner, namely round window stimulation. The reverse stimulation is not well understood, partly because in classic lumped-parameter models the path of reverse drive during the round window stimulation is usually not considered. OBJECTIVE: The study goal is to gain a better understanding of the hearing mechanism during round window stimulation. METHODS: A piezo actuator was coupled to the oval and round window of the guinea pigs. The auditory brainstem response produced by the forward and reverse stimulation at four frequencies was recorded. RESULTS: The results show that the input voltage of the actuator required at the hearing threshold in the round window drive was higher than that in the oval window drive. In order to understand the data, we designed a lumped-parameter cochlear model that can simulate both forward and reverse drive. The model-predicted results were consistent with the experimental results. CONCLUSIONS: The response of the auditory system to stimulus of oval window and round window was quantified through animal experimentation, and guinea pigs were used as experimental animals. When the same stimulus was applied to the oval window and round window of the cochlea, the ABR signals were compared. A lumped parameter model was designed to incorporate the sound transmission paths in both oval and round window stimulation. The simulated results are consistent with those of animal experiments. This model will be useful in understanding the inner-ear response in round window.

Implementation of a 3D position detection system for a medical simulator.

BACKGOROUND AND OBJECTIVE: Cardiovascular disorders are increasing because of poor eating habits, excessive drinking, and lack of exercise. Some of the typical cardiovascular surgical procedures utilize catheters. Catheter-based procedures require the surgeons to have extensive experience and high proficiency at performing vascular interventions. However, the learning period to acquire such proficiency is lengthy and the opportunities for practical training and mastery are insufficient. Therefore, due to insufficient skill, dangerous situations with damage or rupture of the patient's blood vessels may occur, thereby increasing the risk of medical accidents. Hence, it is necessary to have experience and proficiency for performing vascular interventions. Thus, it is necessary to develop a simulator to shorten learning time and reduce medical accidents. METHODS: In this study, we developed a position detection system for the simulator to use physical models to learn cardiovascular surgical intervention techniques. The developed system uses changes in the output values of a Hall sensor based on the position of a permanent magnet. RESULTS AND CONCLUSIONS: From the changing output values, the distance calculation equation is derived, and the position of the permanent magnet is effectively estimated from the calculations. The performance of the position detecting system was tested, and the results proved that the system could be sufficiently used as a simulator.

Implementation of a fully implantable middle-ear hearing device chip.

BACKGROUND AND OBJECTIVE: Recently, with the increase in the population of hearing impaired people, various types of hearing aids have been rapidly developed. In particular, a fully implantable middle ear hearing device (F-IMEHD) is developed for people with sensorineural hearing loss. The F-IMEHD system comprises an implantable microphone, a transducer, and a signal processor. The signal processor should have a small size and consume less power for implantation in a human body. METHODS: In this study, we designed and fabricated a signal-processing chip using the modified FFT algorithm. This algorithm was developed focusing on eliminating time delay and system complexity in the transform process. The designed signal-processing chip comprises a 4-channel WDRC, a fitting memory, a communication 1control part, and a pulse density modulator. Each channel is separated using a 64-point fast Fourier transform (FFT) method and the gain value is matched using the fitting table in the fitting memory. RESULTS AND CONCLUSION: The chip was designed by Verilog-HDL and the designed HDL codes were verified by Modelsim-PE 10.3 (Mentor graphics, USA). The chip was fabricated using a 0.18 µm CMOS process (SMIC, China). Experiments were performed on a cadaver to verify the performance of the fabricated chip.

Design of a dual-coil type electromagnetic actuator for implantable bone conduction hearing devices.

BACKGROUND: This paper describes the design and implementation of a dual-coil type electromagnetic actuator for implantable bone conduction hearing devices. OBJECTIVE: The structure of the proposed actuator was designed to generate maximum Lorentz force via the dual-coil method with a closed magnetic circuit. To satisfy the indications required by implantable bone conduction hearing devices, high output was generated within a specific frequency range using a vibrational membrane with a cantilever. METHODS: The structure of the membrane consists of a fixed ring, a circular plate, and two cantilevers connected symmetrically. Variable elements of the vibrational membrane affecting the actuator frequency characteristics were analyzed through mathematical modeling and finite element analysis, based on the analysis used to derive the optimum structure of the vibrational membrane. The components of the actuator were fabricated through chemical etching and computer numerical control process, and the bone conduction actuator was fabricated through the precision assembly process. RESULTS: The output characteristics of the implemented actuator were measured using a laser Doppler vibrometer. As a result of measurement, the proposed actuator generated mechanical resonance at 1.2 kHz. CONCLUSIONS: By comparing the measured results with the finite element analysis results, we confirmed the validity of the proposed actuator design.

A Vibro-Acoustic Hybrid Implantable Microphone for Middle Ear Hearing Aids and Cochlear Implants.

To develop totally implantable middle ear and cochlear implants, a miniature microphone that is surgically easy to implant and has a high sensitivity in a sufficient range of audio frequencies is needed. Of the various implantable acoustic sensors under development, only micro electro-mechanical system-type acoustic sensors, which attach to the umbo of the tympanic membrane, meet these requirements. We describe a new vibro-acoustic hybrid implantable microphone (VAHIM) that combines acceleration and sound pressure sensors. Each sensor can collect the vibration of the umbo and sound pressure of the middle ear cavity. The fabricated sensor was implanted into a human temporal bone and the noise level and sensitivity were measured. From the experimental results, it is shown that the proposed method is able to provide a wider-frequency band than conventional implantable acoustic sensors.

Noise reduction algorithm with the soft thresholding based on the Shannon entropy and bone-conduction speech cross- correlation bands.

BACKGROUND: The conventional methods of speech enhancement, noise reduction, and voice activity detection are based on the suppression of noise or non-speech components of the target air-conduction signals. However, air-conduced speech is hard to differentiate from babble or white noise signals. OBJECTIVE: To overcome this problem, the proposed algorithm uses the bone-conduction speech signals and soft thresholding based on the Shannon entropy principle and cross-correlation of air- and bone-conduction signals. METHODS: A new algorithm for speech detection and noise reduction is proposed, which makes use of the Shannon entropy principle and cross-correlation with the bone-conduction speech signals to threshold the wavelet packet coefficients of the noisy speech. RESULTS: The proposed method can be get efficient result by objective quality measure that are PESQ, RMSE, Correlation, SNR. CONCLUSION: Each threshold is generated by the entropy and cross-correlation approaches in the decomposed bands using the wavelet packet decomposition. As a result, the noise is reduced by the proposed method using the MATLAB simulation. To verify the method feasibility, we compared the air- and bone-conduction speech signals and their spectra by the proposed method. As a result, high performance of the proposed method is confirmed, which makes it quite instrumental to future applications in communication devices, noisy environment, construction, and military operations.

Biomechanical Comparison of Inter-fragmentary Compression Pressures: Lag Screw versus Herbert Screw for Anterior Odontoid Screw Fixation.

OBJECTIVE: The purpose of the present study was to compare inter-fragmentary compression pressures after fixation of a simulated type II odontoid fracture with the headless compression Herbert screw and a half threaded cannulated lag screw. METHODS: We compared inter-fragmentary compression pressures between 40- and 45-mm long 4.5-mm Herbert screws (n=8 and n=9, respectively) and 40- and 45-mm long 4.0-mm cannulated lag screws (n=7 and n=10, respectively) after insertion into rigid polyurethane foam test blocks (Sawbones, Vashon, WA, USA). A washer load cell was placed between the two segments of test blocks to measure the compression force. Because the total length of each foam block was 42 mm, the 40-mm screws were embedded in the cancellous foam, while the 45-mm screws penetrated the denser cortical foam at the bottom. This enabled us to compare inter-fragmentary compression pressures as they are affected by the penetration of the apical dens tip by the screws. RESULTS: The mean compression pressures of the 40- and 45-mm long cannulated lag screws were 50.48±1.20 N and 53.88±1.02 N, respectively, which was not statistically significant (p=0.0551). The mean compression pressures of the 40-mm long Herbert screw was 52.82±2.17 N, and was not statistically significant compared with the 40-mm long cannulated lag screw (p=0.3679). However, 45-mm Herbert screw had significantly higher mean compression pressure (60.68±2.03 N) than both the 45-mm cannulated lag screw and the 40-mm Herbert screw (p=0.0049 and p=0.0246, respectively). CONCLUSION: Our results showed that inter-fragmentary compression pressures of the Herbert screw were significantly increased when the screw tip penetrated the opposite dens cortical foam. This can support the generally recommended surgical technique that, in order to facilitate maximal reduction of the fracture gap using anterior odontoid screws, it is essential to penetrate the apical dens tip with the screw.

Implementation of automatic external defibrillator using real time ventricular fibrillation detecting algorithm based on time domain analysis.

The increase in mortality associated with arrhythmia is an inevitable problem of modern society such as westernized eating habits and an increase in stress due to industrialization, and the related social costs are increasing. In this regard, the supply of automatic external defibrillator (AED) used outside hospitals is increasing mainly in public institutions, and AED is a medical practice performed by non-medical personnel. Therefore, studies on arrhythmia detection algorithm to make accurate clinical judgment for proper use are increasing. In this paper, we propose a time domain analysis method to detect arrhythmia in real time and implement AED by porting it to programmable gate array and digital signal processor. The analysis of the phase domain improves the detection rate of R-peak using the differentiated electrocardiogram (ECG) waveform rather than the existing ECG waveform and makes it easy to distinguish the normal ECG from the arrhythmia signal in the phase domain. The proposed algorithm was verified by simulation using Labview and ModelSim, and it was verified that the proposed algorithm works effectively by performing animal experiments using the implemented AED.

Mastication noise reduction method for fully implantable hearing aid using piezo-electric sensor.

BACKGROUND: Fully implantable hearing devices (FIHDs) can be affected by generated biomechanical noise such as mastication noise. OBJECTIVE: To reduce the mastication noise using a piezo-electric sensor, the mastication noise is measured with the piezo-electric sensor, and noise reduction is practiced by the energy difference. METHODS: For the experiment on mastication noise, a skull model was designed using artificial skull model and a piezo-electric sensor that can measure the vibration signals better than other sensors. A 1 kHz pure-tone sound through a standard speaker was applied to the model while the lower jawbone of the model was moved in a masticatory fashion. RESULTS: The correlation coefficients and signal-to-noise ratio (SNR) before and after application of the proposed method were compared. It was found that the signal-to-noise ratio and correlation coefficients increased by 4.48 dB and 0.45, respectively. CONCLUSION: The mastication noise is measured by piezo-electric sensor as the mastication noise that occurred during vibration. In addition, the noise was reduced by using the proposed method in conjunction with MATLAB. In order to confirm the performance of the proposed method, the correlation coefficients and signal-to-noise ratio before and after signal processing were calculated. In the future, an implantable microphone for real-time processing will be developed.

Realization of a High Sensitivity Microphone for a Hearing Aid Using a Graphene-PMMA Laminated Diaphragm.

Microphones for hearing aid systems are required to have high sensitivity, an appropriate bandwidth, and a wide dynamic range. In this paper, a high sensitivity microphone, 4 mm in diameter and using a multilayer graphene-PMMA laminated diaphragm that can be applied in hearing aids, is designed, optimized, and implemented. Typically, polyphenylene sulfide (PPS) has been used for the diaphragm of electret condenser microphones (ECM), and this method provides simple, low cost mass production. Generally, the sensitivity of the commercial 4 mm diameter ECM is about -30 to 35 dB (0 dB = 1 V/Pa). A microphone using a nanometer-thick graphene diaphragm has been found to have higher sensitivity than the conventional ECM. However, nanometer-thick multilayer graphene is vulnerable to large mechanical shocks or high sound pressures, and the practical production of nanometer-thick diaphragms also poses a challenge. However, if a multilayer graphene diaphragm of the same thickness as the conventional ECM is used, displacement during diaphragm vibration will be severely attenuated due to the high elastic modulus of graphene, and the microphone sensitivity will be greatly reduced. In this paper, we fabricate a multilayer graphene/poly(methyl methacrylate) (PMMA) laminated diaphragm with sensitivity higher than that of any other microphones currently available for hearing aids, with the appropriate bandwidth in the auditory range. The high sensitivity arises from the laminated structure of the thin graphene membrane with high elastic modulus and from the PMMA membrane with lower elastic modulus and higher dielectric constant. The optimal thickness ratio of the graphene-PMMA layered diaphragm was studied by both analytical and experimental methods, and then a fabricated diaphragm was assembled in a 4 mm diameter microphone package. The performance of the implemented microphone was evaluated, including the sensitivity and total harmonic distortion. It is demonstrated that the microphone using a multilayer graphene-PMMA diaphragm has an excellent sensitivity of -20 dB and a dynamic range of 90 dB, which is on average 9 dB higher than the microphone using the conventional ECM diaphragm.

A tri-coil bellows-type round window transducer with improved frequency characteristics for middle-ear implants.

A number of methods to drive the round window (RW) using a floating mass transducer (FMT) have been reported. This method has attracted attention because the FMT is relatively easy to implant in the RW niche. However, the use of an FMT to drive the RW has been proven to produce low outputs at frequencies below approximately 1 kHz. In this study, a new tri-coil bellows-type transducer (TCBT), which has excellent low frequency output and is easy to implant, is proposed. To design the frequency characteristics of the TCBT, mechanical and electrical simulations were performed, and then a comparative analysis was conducted between a floating mass type transducer (like the FMT) and a fixed type transducer (like the TCBT). The features of the proposed TCBT are as follows. First, the TCBT's housing is fixed to the RW niche so that it does not vibrate. Second, the internal end of a tiny bellows is connected to a vibrating three-pole permanent magnet located within three field coils. Finally, the rim of the bellows bottom is attached to the end of the housing that hermetically encloses the three field coils. In this design, the only vibrating element is the bellows itself, which efficiently drives the RW membrane. To evaluate the characteristics of this newly developed TCBT, the transducer was installed in the RW niche of temporal bones and the velocity of the stapes was measured using a laser Doppler vibrometer. The experimental results indicate that the TCBT can produce 100, 111, and 129 dB SPL equivalent pressure outputs at below 1 kHz, 1-3 kHz, and above 3 kHz, respectively. Thus, the TCBT with one side coupled to the RW via a bellows will be easy to implant and offer better performance than an FMT.

A New Trans-Tympanic Microphone Approach for Fully Implantable Hearing Devices.

Fully implantable hearing devices (FIHDs) have been developed as a new technology to overcome the disadvantages of conventional acoustic hearing aids. The implantable microphones currently used in FIHDs, however, have difficulty achieving high sensitivity to environmental sounds, low sensitivity to body noise, and ease of implantation. In general, implantable microphones may be placed under the skin in the temporal bone region of the skull. In this situation, body noise picked up during mastication and touching can be significant, and the layer of skin and hair can both attenuate and distort sounds. The new approach presently proposed is a microphone implanted at the tympanic membrane. This method increases the microphone's sensitivity by utilizing the pinna's directionally dependent sound collection capabilities and the natural resonances of the ear canal. The sensitivity and insertion loss of this microphone were measured in human cadaveric specimens in the 0.1 to 16 kHz frequency range. In addition, the maximum stable gain due to feedback between the trans-tympanic microphone and a round-window-drive transducer, was measured. The results confirmed in situ high-performance capabilities of the proposed trans-tympanic microphone.

Wireless charing pillow for a fully implantable hearing aid: Design of a circular array coil based on finite element analysis for reducing magnetic weak zones.

Many types of fully implantable hearing aids have been developed. Most of these devices are implanted behind the ear. To maintain the implanted device for a long period of time, a rechargeable battery and wireless power transmission are used. Because inductive coupling is the most renowned method for wireless power transmission, many types of fully implantable hearing aids are transcutaneously powered using inductively coupled coils. Some patients with an implantable hearing aid require a method for conveniently charging their hearing aid while they are resting or sleeping. To address this need, a wireless charging pillow has been developed that employs a circular array coil as one of its primary parts. In this device, all primary coils are simultaneously driven to maintain an effective charging area regardless of head motion. In this case, however, there may be a magnetic weak zone that cannot be charged at the specific secondary coil's location on the array coil. In this study, assuming that a maximum charging distance is 4 cm, a circular array coil-serving as a primary part of the charging pillow-was designed using finite element analysis. Based on experimental results, the proposed device can charge an implantable hearing aid without a magnetic weak zone within 4 cm of the perpendicular distance between the primary and secondary coils.

Implementation of a direct install 3-pole type EM transducer in round window niche for implantable middle ear hearing aids.

Since the 1980's, various types of implantable hearing aids using unique means for delivering acoustic power to the inner ear have been developed. Recently, implantable hearing aids that stimulate the round window by the middle ear transducer have received great attention because it reduces loading effect at the ossicular chain. In this study, we have implemented a direct install 3-pole type EM transducer in round window niche for implantable middle ear hearing aid. The 3-pole type EM transducer consists of two permanent magnets and three coils and exhibit structural features that minimize leakage flux, thereby permitting high efficiency and low magnetic field interference. The stapes velocity was measured using a laser Doppler vibrometer in response to the round window stimulation from the transducer. To verify the usefulness of the 3-pole type EM transducer, we compared the stapes vibration characteristics produced by the transducer and those from a sound source. The magnitude of stapes velocity due to the round window stimulation at 1 mArms was equivalent to that of stapes velocity at 94 dB SPL sound stimulation. Thus, the evaluation study shows that the 3-pole type EM transducer is suitable for implantable hearing devices.

Development of visible and NIR imaging equipment for small animals with smart pad.

The portable visible and near-infrared (NIR) imaging equipment for a pre-clinical test with small animals was designed and developed in this paper. The developed equipment is composed of a CCD camera, a focusing lens, an objective lens, a NIR band pass filter and a NIR filter driving motor. An NIR ray is mainly used for imaging equipment because it has high light penetration depth in biological tissue. Therefore, NIR fluorescent agents are available for chemical conjugation to targeting molecules in vivo. This equipment can provide a visible image, NIR image and merged image simultaneously. A communication system was specifically established to check obtained images through a smart pad in real time. It is less dependent on space and time than the conventional system.

Speech quality evaluation of subcutaneously implanted microphone using in vivo experiment.

The microphone in a fully implantable hearing device (FIHD) is generally implanted under the skin covering the temporal bone. However, the implanted microphone can be affected by the skin, which causes both sound attenuation and distortion, particularly at high frequencies. As the degree of attenuation and distortion through the skin is severe, speech quality evaluation parameters are needed for the received signal when designing an implantable microphone. However, the performance of most implantable microphones is only assessed based on the sensitivity and frequency response. Thus, practical indicators based on human auditory characteristics are needed for an objective evaluation of the performance of implantable microphones. In this study, a subcutaneously implantable microphone was designed, and its frequency response investigated using an in vivo experiment. Plus, to evaluate the objective indicators, the speech quality of the signals measured by the implanted microphone was calculated using a MATLAB program, and the indicators compared before and after implantation.

Measurement of stapes vibration in Human temporal bones by round window stimulation using a 3-coil transducer.

Round window placement of a 3-coil transducer offers a new approach for coupling an implantable hearing aid to the inner ear. The transducer exhibits high performance at low-frequencies. One remarkable feature of the 3-coil transducer is that it minimizes leakage flux. Thus, the transducer, which consists of two permanent magnets and three coils, can enhance vibrational displacement. In human temporal bones, stapes vibration was observed by laser Doppler vibrometer in response to round window stimulation using the 3-coil transducer. Coupling between the 3-coil transducer and the round window was connected by a wire-rod. The stimulation created stapes velocity when the round window stimulated. Performance evaluation was conducted by measuring stapes velocity. To verify the performance of the 3-coil transducer, stapes velocity for round window and tympanic membrane stimulation were compared, respectively. Stapes velocity by round window stimulation using the 3-coil transducer was approximately 14 dB higher than that achieved by tympanic membrane stimulation. The study shows that 3-coil transducer is suitable for implantable hearing aids.

In vivo evaluation of mastication noise reduction for dual channel implantable microphone.

Input for fully implantable hearing devices (FIHDs) is provided by an implantable microphone under the skin of the temporal bone. However, the implanted microphone can be affected when the FIHDs user chews. In this paper, a dual implantable microphone was designed that can filter out the noise from mastication. For the in vivo experiment, a fabricated microphone was implanted in a rabbit. Pure-tone sounds of 1 kHz through a standard speaker were applied to the rabbit, which was given food simultaneously. To evaluate noise reduction, the measured signals were processed using a MATLAB program based adaptive filter. To verify the proposed method, the correlation coefficients and signal to-noise ratio before and after signal processing were calculated. By comparing the results, signal-to-noise ratio and correlation coefficients are enhanced by 6.07dB and 0.529 respectively.