Individual Optimization of the Insertion of a Preformed Cochlear Implant Electrode Array

Purpose. The aim of this study was to show that individual adjustment of the curling behaviour of a preformed cochlear implant (CI) electrode array to the patient-specific shape of the cochlea can improve the insertion process in terms of reduced risk of insertion trauma. Methods. Geometry and curling behaviour of preformed, commercially available electrode arrays were modelled. Additionally, the anatomy of each small, medium-sized, and large human cochlea was modelled to consider anatomical variations. Finally, using a custom-made simulation tool, three different insertion strategies (conventional Advanced Off-Stylet (AOS) insertion technique, an automated implementation of the AOS technique, and a manually optimized insertion process) were simulated and compared with respect to the risk of insertion-related trauma. The risk of trauma was evaluated using a newly developed “trauma risk” rating scale. Results. Using this simulation-based approach, it was shown that an individually optimized insertion procedure is advantageous compared with the AOS insertion technique. Conclusion. This finding leads to the conclusion that, in general, consideration of the specific curling behaviour of a CI electrode array is beneficial in terms of less traumatic insertion. Therefore, these results highlight an entirely novel aspect of clinical application of preformed perimodiolar electrode arrays in general

Computational evaluation of cochlear implant surgery outcomes accounting for uncertainty and parameter variability

Cochlear implantation (CI) is a complex surgical procedure that restores hearing in patients with severe deafness. The successful outcome of the implanted device relies on a group of factors, some of them unpredictable or difficult to control. Uncertainties on the electrode array position and the electrical properties of the bone make it difficult to accurately compute the current propagation delivered by the implant and the resulting neural activation. In this context, we use uncertainty quantification methods to explore how these uncertainties propagate through all the stages of CI computational simulations. To this end, we employ an automatic framework, encompassing from the finite element generation of CI models to the assessment of the neural response induced by the implant stimulation. To estimate the confidence intervals of the simulated neural response, we propose two approaches. First, we encode the variability of the cochlear morphology among the population through a statistical shape model. This allows us to generate a population of virtual patients using Monte Carlo sampling and to assign to each of them a set of parameter values according to a statistical distribution. The framework is implemented and parallelized in a High Throughput Computing environment that enables to maximize the available computing resources. Secondly, we perform a patient-specific study to evaluate the computed neural response to seek the optimal post-implantation stimulus levels. Considering a single cochlear morphology, the uncertainty in tissue electrical resistivity and surgical insertion parameters is propagated using the Probabilistic Collocation method, which reduces the number of samples to evaluate. Results show that bone resistivity has the highest influence on CI outcomes. In conjunction with the variability of the cochlear length, worst outcomes are obtained for small cochleae with high resistivity values. However, the effect of the surgical insertion length on the CI outcomes could not be clearly observed, since its impact may be concealed by the other considered parameters. Whereas the Monte Carlo approach implies a high computational cost, Probabilistic Collocation presents a suitable trade-off between precision and computational time. Results suggest that the proposed framework has a great potential to help in both surgical planning decisions and in the audiological setting process

A BACKING DEVICE BASED ON AN EMBEDDED STIFFENER AND RETRACTABLE INSERTION TOOL FOR THIN-FILM COCHLEAR ARRAYS

Intracochlear trauma from surgical insertion of bulky electrode arrays and inadequate pitch perception are areas of concern with current hand-assembled commercial cochlear implants. Parylene thin-film arrays with higher electrode densities and lower profiles are a potential solution, but lack rigidity and hence depend on manually fabricated permanently attached polyethylene terephthalate (PET) tubing based bulky backing devices. As a solution, we investigated a new backing device with two sub-systems. The first sub-system is a thin poly(lactic acid) (PLA) stiffener that will be embedded in the parylene array. The second sub-system is an attaching and detaching mechanism, utilizing a poly(N-vinylpyrrolidone)-block-poly(d,l-lactide) (PVP-b-PDLLA) copolymer-based biodegradable and water soluble adhesive, that will help to retract the PET insertion tool after implantation. As a proof-of-concept of sub-system one, a microfabrication process for patterning PLA stiffeners embedded in parylene has been developed. Conventional hotembossing, mechanical micromachining, and standard cleanroom processes were integrated for patterning fully released and discrete stiffeners coated with parylene. The released embedded stiffeners were thermoformed to demonstrate that imparting perimodiolar shapes to stiffener-embedded arrays will be possible. The developed process when integrated with the array fabrication process will allow fabrication of stiffener-embedded arrays in a single process. As a proof-of-concept of sub-system two, the feasibility of the attaching and detaching mechanism was demonstrated by adhering 1x and 1.5x scale PET tube-based insertion tools and PLA stiffeners embedded in parylene using the copolymer adhesive. The attached devices survived qualitative adhesion tests, thermoforming, and flexing. The viability of the detaching mechanism was tested by aging the assemblies in-vitro in phosphate buffer solution. The average detachment times, 2.6 minutes and 10 minutes for 1x and 1.5x scale devices respectively, were found to be clinically relevant with respect to the reported array insertion times during surgical implantation. Eventually, the stiffener-embedded arrays would not need to be permanently attached to current insertion tools which are left behind after implantation and congest the cochlear scala tympani chamber. Finally, a simulation-based approach for accelerated failure analysis of PLA stiffeners and characterization of PVP-b-PDLLA copolymer adhesive has been explored. The residual functional life of embedded PLA stiffeners exposed to body-fluid and thereby subjected to degradation and erosion has been estimated by simulating PLA stiffeners with different parylene coating failure types and different PLA types for a given parylene coating failure type. For characterizing the PVP-b-PDLLA copolymer adhesive, several formulations of the copolymer adhesive were simulated and compared based on the insertion tool detachment times that were predicted from the dissolution, degradation, and erosion behavior of the simulated adhesive formulations. Results indicate that the simulation-based approaches could be used to reduce the total number of time consuming and expensive in-vitro tests that must be conducted

Ultraminiature Piezoelectric Implantable Acoustic Transducers for Biomedical Applications

Miniature piezoelectric acoustic transducers have been developed for numerous applications. Compared to other transduction mechanisms like capacitive or piezoresistive, piezoelectric transducers do not need direct current (DC) bias voltage and can work directly exposed to fluid. Hence, they are good candidates for biomedical applications that often require the transducer to work in water based fluid. Among all piezoelectric materials, aluminum nitride (AlN) is a great choice for implantable sensors because of the high electrical resistance, low dielectric loss, and biocompatibility for in vivo study. This thesis presents the design, modeling, fabrication, and testing of the AlN acoustic transducers, miniaturized to be implantable for biomedical applications like hearing or cardiovascular devices. To design and model the transducer in air and in water, a 3D finite element analysis (FEA) model was built to study the transducer in a viscous fluid environment. An array of AlN bimorph cantilevers were designed to create a multi-resonance transducer to increase the sensitivity in a broad band frequency range. A two-wafer process using microelectricalmechanical systems (MEMS) techniques was used to fabricate the xylophone transducer with flexible cable. Benchtop testing confirmed the transducer functionality and verified the FEA model experimentally. The transducer was then implanted inside a living cochlea of a guinea pig and tested in vivo. The piezoelectric voltage output from the transducer was measured in response to 80-95 dB sound pressure level (SPL) sinusoidal excitation spanning 1-14 kHz. The phases showed clear acoustic delay. The measured voltage responses were linear and above the noise level. These results demonstrated that the transducer can work as a sensor for a fully implantable cochlear implant. The second generation device, an ultraminiature diaphragm transducer, was designed to be smaller, and yet with an even lower noise floor. The transducer was designed and optimized using a 2D axial-symmetric FEA model for a better figure of merit (FOM), which considered both minimal detectable pressure (MDP) and the diaphragm area. The low-frequency sensitivity was increased significantly, because of the encapsulated back cavity. Because of this merit, cardiovascular applications, which focus on low frequency signals, were also investigated. The diaphragm transducers were fabricated using MEMS techniques. Benchtop tests for both actuating and sensing confirmed the transducer functionality, and verified the design and model experimentally. The transducer had a better FOM than other existing piezoelectric diaphragm transducers, and it had a much lower MDP than the other intracochlear acoustic sensors.PHDMechanical EngineeringUniversity of Michigan, Horace H. Rackham School of Graduate Studieshttps://deepblue.lib.umich.edu/bitstream/2027.42/147673/1/chumingz_1.pd

Computational algorithms for the segmentation of the human ear

The main goal of this project is to identify an efficient segmentation algorithm for each anatomic structure of the ear. Therefore, in this paper, it is presented and analyzed computational algorithms that have been used to segment structures in images, especially of the human ear in Computed Tomography (CT) images

A Model for Electrical Communication Between Cochlear Implants and the Brain

In the last thirty years, cochlear implants have become an invaluable instrument in the treatment of severe-to-profound hearing impairment. An important aspect of research in the continued development of cochlear implants is the in vivo assessment of signal processing algorithms intended to improve perception of speech and other auditory signals. In trying to determine how closely cochlear implant recipients process sound relative to the processing done by a normal auditory system, various assessment techniques have been applied. The most common technique has been measurement of auditory evoked potentials (AEPs), which involves the recording of neural responses to auditory stimulation. Depending on the latency of the observed response, the evoked potential indicates neural activity at various ascending neurological structures of the auditory system. Although there have been a number of publications on the topic of AEPs in cochlear implant subjects, there is a need for better measurement and research techniques to obtain more in-depth information to facilitate research on effectiveness of signal processing approaches in cochlear implants. The research presented herein explored the use of MatLab for the purpose of developing a model for electrically evoked auditory brainstem responses (EABRs). The EABR is commonly measured in hearing-impaired patients who have cochlear implants, via electrical stimulation delivered from electrodes in the implanted array. The simulation model developed in this study took as its input the stimulus current intensity level, and used function vectors and equations derived from measured EABRs, to generate an approximation of the evoked surface potentials. A function vector was used to represent the combined firing of the neurons of the auditory nervous system that are needed to elicit a measurable response. Equations were derived to represent the latency and stimulus amplitude scaling functions. The simulation also accounted for other neural activity that can be present in and contaminate an ABR recording, and reduced it through time-locked averaging of the simulated response. Predicted waveforms from the MatLab model were compared both to published waveforms from a cochlear implant recipient, and a series of EABR waveforms measured by the author in other cochlear implant recipients. Measurement of the EABRs required specialized interfacing of a commercial recording system with the signal processors of the patients\u27 cochlear implants. A novel measurement technique was also used to obtain more frequency-specific information than usually obtained. Although the nonlinearities normally present in the auditory system were not considered in this MatLab simulation, the model nevertheless performed well and delivered results comparing favorably with the results measured from the research subjects

Three-dimensional histological specimen preparation for accurate imaging and spatial reconstruction of the middle and inner ear

PURPOSE:    This paper presents a highly accurate cross-sectional preparation technique. The research aim was to develop an adequate imaging modality for both soft and bony tissue structures featuring high contrast and high resolution. Therefore, the advancement of an already existing microgrinding procedure was pursued. The central objectives were to preserve spatial relations and to ensure the accurate three-dimensional reconstruction of histological sections. METHODS:    Twelve human temporal bone specimens including middle and inner ear structures were utilized. They were embedded in epoxy resin, then dissected by serial grinding and finally digitalized. The actual abrasion of each grinding slice was measured using a tactile length gauge with an accuracy of one micrometre. The cross-sectional images were aligned with the aid of artificial markers and by applying a feature-based, custom-made auto-registration algorithm. To determine the accuracy of the overall reconstruction procedure, a well-known reference object was used for comparison. To ensure the compatibility of the histological data with conventional clinical image data, the image stacks were finally converted into the DICOM standard. RESULTS:    The image fusion of data from temporal bone specimens’ and from non-destructive flat-panel-based volume computed tomography confirmed the spatial accuracy achieved by the procedure, as did the evaluation using the reference object. CONCLUSION:    This systematic and easy-to-follow preparation technique enables the three-dimensional (3D) histological reconstruction of complex soft and bony tissue structures. It facilitates the creation of detailed and spatially correct 3D anatomical models. Such models are of great benefit for image-based segmentation and planning in the field of computer-assisted surgery as well as in finite element analysis. In the context of human inner ear surgery, three-dimensional histology will improve the experimental evaluation and determination of intra-cochlear trauma after the insertion of an electrode array of a cochlear implant system

Auf einem menschlichen Gehörmodell basierende Elektrodenstimulationsstrategie für Cochleaimplantate

Cochleaimplantate (CI), verbunden mit einer professionellen Rehabilitation, haben mehreren hunderttausenden Hörgeschädigten die verbale Kommunikation wieder ermöglicht. Betrachtet man jedoch die Rehabilitationserfolge, so haben CI-Systeme inzwischen ihre Grenzen erreicht. Die Tatsache, dass die meisten CI-Träger nicht in der Lage sind, Musik zu genießen oder einer Konversation in geräuschvoller Umgebung zu folgen, zeigt, dass es noch Raum für Verbesserungen gibt.Diese Dissertation stellt die neue CI-Signalverarbeitungsstrategie Stimulation based on Auditory Modeling (SAM) vor, die vollständig auf einem Computermodell des menschlichen peripheren Hörsystems beruht.Im Rahmen der vorliegenden Arbeit wurde die SAM Strategie dreifach evaluiert: mit vereinfachten Wahrnehmungsmodellen von CI-Nutzern, mit fünf CI-Nutzern, und mit 27 Normalhörenden mittels eines akustischen Modells der CI-Wahrnehmung. Die Evaluationsergebnisse wurden stets mit Ergebnissen, die durch die Verwendung der Advanced Combination Encoder (ACE) Strategie ermittelt wurden, verglichen. ACE stellt die zurzeit verbreitetste Strategie dar. Erste Simulationen zeigten, dass die Sprachverständlichkeit mit SAM genauso gut wie mit ACE ist. Weiterhin lieferte SAM genauere binaurale Merkmale, was potentiell zu einer Verbesserung der Schallquellenlokalisierungfähigkeit führen kann. Die Simulationen zeigten ebenfalls einen erhöhten Anteil an zeitlichen Pitchinformationen, welche von SAM bereitgestellt wurden. Die Ergebnisse der nachfolgenden Pilotstudie mit fünf CI-Nutzern zeigten mehrere Vorteile von SAM auf. Erstens war eine signifikante Verbesserung der Tonhöhenunterscheidung bei Sinustönen und gesungenen Vokalen zu erkennen. Zweitens bestätigten CI-Nutzer, die kontralateral mit einem Hörgerät versorgt waren, eine natürlicheren Klangeindruck. Als ein sehr bedeutender Vorteil stellte sich drittens heraus, dass sich alle Testpersonen in sehr kurzer Zeit (ca. 10 bis 30 Minuten) an SAM gewöhnen konnten. Dies ist besonders wichtig, da typischerweise Wochen oder Monate nötig sind. Tests mit Normalhörenden lieferten weitere Nachweise für die verbesserte Tonhöhenunterscheidung mit SAM.Obwohl SAM noch keine marktreife Alternative ist, versucht sie den Weg für zukünftige Strategien, die auf Gehörmodellen beruhen, zu ebnen und ist somit ein erfolgversprechender Kandidat für weitere Forschungsarbeiten.Cochlear implants (CIs) combined with professional rehabilitation have enabled several hundreds of thousands of hearing-impaired individuals to re-enter the world of verbal communication. Though very successful, current CI systems seem to have reached their peak potential. The fact that most recipients claim not to enjoy listening to music and are not capable of carrying on a conversation in noisy or reverberative environments shows that there is still room for improvement.This dissertation presents a new cochlear implant signal processing strategy called Stimulation based on Auditory Modeling (SAM), which is completely based on a computational model of the human peripheral auditory system.SAM has been evaluated through simplified models of CI listeners, with five cochlear implant users, and with 27 normal-hearing subjects using an acoustic model of CI perception. Results have always been compared to those acquired using Advanced Combination Encoder (ACE), which is today’s most prevalent CI strategy. First simulations showed that speech intelligibility of CI users fitted with SAM should be just as good as that of CI listeners fitted with ACE. Furthermore, it has been shown that SAM provides more accurate binaural cues, which can potentially enhance the sound source localization ability of bilaterally fitted implantees. Simulations have also revealed an increased amount of temporal pitch information provided by SAM. The subsequent pilot study, which ran smoothly, revealed several benefits of using SAM. First, there was a significant improvement in pitch discrimination of pure tones and sung vowels. Second, CI users fitted with a contralateral hearing aid reported a more natural sound of both speech and music. Third, all subjects were accustomed to SAM in a very short period of time (in the order of 10 to 30 minutes), which is particularly important given that a successful CI strategy change typically takes weeks to months. An additional test with 27 normal-hearing listeners using an acoustic model of CI perception delivered further evidence for improved pitch discrimination ability with SAM as compared to ACE.Although SAM is not yet a market-ready alternative, it strives to pave the way for future strategies based on auditory models and it is a promising candidate for further research and investigation

Qualitative effect of tissue heterogeneity and modiolus porosity on the transmembrane potential of type-1 spiral ganglion neurons in the human cochlea: a simulation study

Electric stimulation of auditory nerve by cochlear implants has been a successful clinical intervention to treat the sensorineural deafness. However, various micro-anatomical factors have not been considered in the state of the art models while studying the interaction between the applied electric field and the auditory nerve. The present finite element modeling study suggests that the modiolus porosity and tissue heterogeneity significantly alter the electric field distribution in the Rosenthal’s canal and thereby affect the cochlear implant functionality