Insertion Of Electrode Array Research Articles

Neural Adaptation of the Electrically Stimulated Auditory Nerve Is Not Affected by Advanced Age in Postlingually Deafened, Middle-aged, and Elderly Adult Cochlear Implant Users.

This study aimed to investigate the associations between advanced age and the amount and the speed of neural adaptation of the electrically stimulated auditory nerve (AN) in postlingually deafened adult cochlear implant (CI) users. Study participants included 26 postlingually deafened adult CI users, ranging in age between 28.7 and 84.0 years (mean: 63.8 years, SD: 14.4 years) at the time of testing. All study participants used a Cochlear Nucleus device with a full electrode array insertion in the test ear. The stimulus was a 100-ms pulse train with a pulse rate of 500, 900, 1800, or 2400 pulses per second (pps) per channel. The stimulus was presented at the maximum comfortable level measured at 2400 pps with a presentation rate of 2 Hz. Neural adaptation of the AN was evaluated using electrophysiological measures of the electrically evoked compound action potential (eCAP). The amount of neural adaptation was quantified by the adaptation index (AI) within three time windows: around 0 to 8 ms (window 1), 44 to 50 ms (window 2), and 94 to 100 ms (window 3). The speed of neural adaptation was quantified using a two-parameter power law estimation. In 23 participants, four electrodes across the electrode array were tested. In three participants, three electrodes were tested. Results measured at different electrode locations were averaged for each participant at each pulse rate to get an overall representation of neural adaptation properties of the AN across the cochlea. Linear-mixed models (LMMs) were used (1) to evaluate the effects of age at testing and pulse rate on the speed of neural adaptation and (2) to assess the effects of age at testing, pulse rate, and duration of stimulation (i.e., time window) on the amount of neural adaptation in these participants. There was substantial variability in both the amount and the speed of neural adaptation of the AN among study participants. The amount and the speed of neural adaptation increased at higher pulse rates. In addition, larger amounts of adaptation were observed for longer durations of stimulation. There was no significant effect of age on the speed or the amount of neural adaptation. The amount and the speed of neural adaptation of the AN are affected by both the pulse rate and the duration of stimulation, with higher pulse rates and longer durations of stimulation leading to faster and greater neural adaptation. Advanced age does not affect neural adaptation of the AN in postlingually deafened, middle-aged and elderly adult CI users.

Development and Characterization of an Electrocochleography-Guided Robotics-Assisted Cochlear Implant Array Insertion System.

Electrocochleography (ECochG) is increasingly being used during cochlear implant (CI) surgery to detect and mitigate insertion-related intracochlear trauma, where a drop in ECochG signal has been shown to correlate with a decline in hearing outcomes. In this study, an ECochG-guided robotics-assisted CI insertion system was developed and characterized that provides controlled and consistent electrode array insertions while monitoring and adapting to real-time ECochG signals. Experimental research. A research laboratory and animal testing facility. A proof-of-concept benchtop study evaluated the ability of the system to detect simulated ECochG signal changes and robotically adapt the insertion. Additionally, the ECochG-guided insertion system was evaluated in a pilot in vivo sheep study to characterize the signal-to-noise ratio and amplitude of ECochG recordings during robotics-assisted insertions. The system comprises an electrode array insertion drive unit, an extracochlear recording electrode module, and a control console that interfaces with both components and the surgeon. The system exhibited a microvolt signal resolution and a response time <100 milliseconds after signal change detection, indicating that the system can detect changes and respond faster than a human. Additionally, animal results demonstrated that the system was capable of recording ECochG signals with a high signal-to-noise ratio and sufficient amplitude. An ECochG-guided robotics-assisted CI insertion system can detect real-time drops in ECochG signals during electrode array insertions and immediately alter the insertion motion. The system may provide a surgeon the means to monitor and reduce CI insertion-related trauma beyond manual insertion techniques for improved CI hearing outcomes.

Illustrating orientation changes of the insertion trajectory during cochlear implant electrode array insertion

Abstract Introduction: Recent investigations focused on the optimization of atraumatic cochlear implant surgery have highlighted the relevance of the electrode array (EA) insertion trajectory. This is particularly studied in the context of minimally-invasive “keyhole” and robotic-assisted approaches, e.g. to avoid injuring structures inside and outside the cochlea. However, little is known about the natural, manual movements and trajectory followed during the insertion process. The present work illustrates the orientation changes within the trajectory a surgeon follows during insertions of EAs into a human cadaveric cochlea. Methods: An EA insertion tool equipped with a gyroscope was developed in our laboratory. During the insertion trials, the gyroscope captures the tool’s spatial orientation. A human head specimen and a single EA were used to perform insertions into a cochlea. A cochlear implant surgeon performed all insertion trials. The recorded orientations were compared to the initial orientation upon cochlea entry to assess the surgeon’s range of motion by calculating the angle between orientation vectors. Results: Fifteen EA insertions were performed with a median maximal deviation from the initial orientation of 7.2° (5.3 -11.1°) across trials. The largest orientation changes were seen towards the last half of each insertion trial. A negative relationship between degree of axis change and number of insertion trial was observed (r = -0.5). Conclusion: Manual EA insertions into a cadaveric cochlea revealed an insertion trajectory with maximum orientation changes of approximately &lt; 10° degrees. The observed trend on decreasing range of motion with increasing number of insertion trials may be attributed to surgeon’s familiarization with the insertion trajectory for this specific specimen but other contributing factors (e.g. EA softening) need to be further elucidated with several EAs. Future evaluations can help determine if this orientation change is influenced by surgeon expertise.

Reliability of start and stop control of hydraulic actuation for the insertion of electrode arrays

Abstract Atraumatic insertions of electrode arrays (EA) into the cochlea aim to preserve natural structures and residual hearing. However, there is a limit as to how smooth and slow a surgeon can insert an EA. As a potential solution, we recently presented a tool (cochlea hydro drive, CHD) that makes use of an infusion pump to prompt and control the desired, continuous and very slow (&lt; 1 mm/s) forward movement for such insertions. The present work further describes the onset, delay and cessation of the hydraulic actuation in response to different start and stop mechanisms, to better understand the safety of its application for cochlear implant surgery. Methods: Our previously designed tool was used to perform insertions of an EA into an artificial scala tympani model. The prototype is designed to hold an EA, which is then actuated by a standard infusion pump programmed to operate at 0.4 mm/ and 0.1 mm/s. A tubing system between the CHD and the pump includes a three-way valve. Ten insertions were operated using the functions of the pump and ten using the valve. Results: From the programmed start to the actual movement, we observed a larger average delay using the pump’s start function (5 s at 0.4 mm/s; 17 s at 0.1 mm/s) vs. opening the valve (&lt; 0.7 s for both velocities). Moreover, the average cessation of movement with the valve closure was almost immediate (0.7 s for both velocities; this corresponds to &lt; 0.1 mm with the slower tested velocity), as opposed to 60- 80 s delay when using the pump’s stop function. Conclusion: The use of a 3-way valve facilitates motion cessation to the high accuracy level required for cochlear implant surgery. These promising findings support future clinical translation of our tool.

A software for online monitoring of orientation-compensated forces during CI insertion

Abstract The electrode array insertion is a critical point during CI surgery and should be performed as gently as possible to preserve residual hearing. In order to measure occurring forces, an insertion tool with an integrated force sensor and an inertial measurement unit (IM U) is being developed. The weight of the electrode holder and the sensor add an unknown offset to the measured forces, depending on the tool orientation. To address this problem, a software which calculates the orientation-induced error and computes a corrected force was developed. The software was written in C++ using the library Qt 5.12.9. For maximization of the computing frequency, the data acquisition of both sensors and the monitoring was parallelized. An algorithm was developed to calculate the error caused by the electrode holder and sensor. For this purpose both weights were determined in a calibration procedure and merged with the provided IM U data. The evaluation was done in two test series (each n=5) with different initial tool orientations. To this end a stepwise 360° rotation around the horizontal axis was performed, while recording the corrected forces. The developed software allows a computing frequency up to 100 Hz with a latency of 10 ms for the online monitoring of the processed data. The evaluation of the corrected force shows a residual error of 0.347 mN ± 0.325 mN for the first and 0.176 mN ± 1.971 mN for the second test series. With the created algorithm, the impact of the extra weight on the sensor can be almost fully equalized. The highly responsive software offers a new possibility to process insertion forces and provide feedback to surgeons. Determining the influence of the tool orientation on the corrected forces is the subject of future researches.

A Capacitive Cochlear Implant Electrode Array Sensing System to Discriminate Fold-Over Pattern.

Purpose During insertion of the cochlear implant electrode array, the tip of the array may fold back on itself and can cause serious complications to patients. This article presents a sensing system for cochlear implantation in a cochlear model. The electrode array fold-over behaviors can be detected by analyzing capacitive information from the array tip. Method Depending on the angle of the array tip against the cochlear inner wall when it enters the cochlear model, different insertion patterns of the electrode array could occur, including smooth insertion, buckling, and fold-over. The insertion force simulating the haptic feedback for surgeons and bipolar capacitance signals during the insertion progress were collected and compared. The Pearson correlation coefficient (PCC) was applied to the collected capacitive signals to discriminate the fold-over pattern. Results Forty-six electrode array insertions were conducted and the deviation of the measured insertion force varies between a range of 20% and 30%. The capacitance values from electrode pair (1, 2) were recorded for analyzing. A threshold for the PCC is set to be 0.94 that can successfully discriminate the fold over insertions from the other two types of insertions, with a success rate of 97.83%. Conclusions Capacitive measurement is an effective method for the detection of faulty insertions and the maximization of the outcome of cochlear implantation. The proposed capacitive sensing system can be used in other tissue implants in vessels, spinal cord, or heart.

Zwitterionic Photografted Coatings of Cochlear Implant Biomaterials Reduce Friction and Insertion Forces.

Application of photografted zwitterionic coatings to cochlear implant (CI) biomaterials will reduce friction and insertion forces. Strategies to minimize intracochlear trauma during implantation of an electrode array are critical to optimize outcomes including preservation of residual hearing. To this end, advances in thin-film zwitterionic hydrogel coatings on relevant biomaterials may show promise, in addition to the potential of these materials for decreasing the intracochlear foreign body response. Using a recently designed one-step process, thin-film coatings derived from zwitterionic sulfobetaine methacrylate (SBMA) were photopolymerized and photografted to the surface of polydimethylsiloxane (PDMS, silastic) samples and also to CI arrays from two manufacturers. Fluorescein staining and scanning electron microscopy with energy-dispersive X-ray spectroscopy verified and characterized the coatings. Tribometry was used to measure the coefficient of friction between uncoated and coated PDMS and synthetic and biological tissues. Force transducer measurements were obtained during insertion of uncoated (n = 9) and coated (n = 9) CI electrode arrays into human cadaveric cochleae. SBMA thin-film coating of PDMS resulted in >90% reduction in frictional coefficients with steel, ceramic, and dermal tissue from guinea pigs (p < 0.0001). We employed a novel method for applying covalently bonded, durable, and uniform coating in geographically selective areas at the electrode array portion of the implant. Image analysis confirmed uniform coating of PDMS systems and the CI electrode arrays with SBMA polymer films. During insertion of electrode arrays into human cadaveric cochleae, SBMA coatings reduced maximum force by ∼40% during insertion (p < 0.001), as well as decreasing force variability and the overall work of insertion. Thin-film SBMA photografted coatings on PDMS and electrode arrays significantly reduce frictional coefficients and insertional forces in cadaveric cochleae. These encouraging findings support that thin-film zwitterionic coating of CI electrode arrays may potentially reduce insertional trauma and thereby promote improved hearing and other long-term outcomes.

Atraumatic Insertion of a Cochlear Implant Pre-Curved Electrode Array by a Robot-Automated Alignment with the Coiling Direction of the Scala Tympani

Introduction: Electrode array translocation is an unpredictable event with all types of arrays, even using a teleoperated robot in a clinical scenario. We aimed to compare the intracochlear trauma produced by the HiFocus™ Mid-Scala (MS) electrode array (Advanced Bionics, Valencia, CA, USA) using a teleoperated robot, with an automated robot connected to a navigation system to align the pre-curved tip of the electrode array with the coiling direction of the scala tympani (ST). Methods: Fifteen freshly frozen temporal bones were implanted with the MS array using the RobOtol® (Collin, Bagneux, France). In the first group (n = 10), the robot was teleoperated to insert the electrode array into the basal turn of the ST under stereomicroscopic vision, and then the array was driven by a slow-speed hydraulic insertion technique with an estimated placement of the pre-curved electrode tip. In the second group (n = 5), 3 points were obtained from the preoperative cone-beam computed tomography: the 2 first defining the ST insertion axis of the basal turn and a third one at the center of the ST at 270°. They provided the information to the automated system (RobOtol® connected with a navigation system) to automatically align the electrode array with the ST insertion axis and to aim the pre-curved tip toward the subsequent coiling of the ST. After this, the electrode array was manually advanced. Finally, the cochleae were obtained and fixed in a crystal resin, and the position of each electrode was determined by a micro-grinding technique. Results: In all cases, the electrode array was fully inserted into the cochlea and the depth of insertion was similar using both techniques. With the teleoperated robotic technique, translocations of the array were observed in 7/10 insertions (70%), but neither trauma nor array translocation occurred with automated robotic insertion. Conclusion: We have successfully tested an automated insertion system (robot + navigation) that could accurately align a pre-curved electrode array to the axis of the basal turn of the ST and its subsequent coiling, which reduced intracochlear insertion trauma and translocation.

Effect of electrode array type and insertion technique on the insertion force: in vitro cochlear model study

Objective: To investigate the effect of insertion technique and electrode array type on the insertion force of electrode array, and to provide a basis for further optimizing electrode design and facilitating mini-invasive electrode insertion. Methods: Three types of electrode array from Nurotron (Standard Electrode, Slim-medium Electrode, Slim-long Electrode) were studied. from July 2019 to December 2019. These electrode arrays were inserted into the phantom models of the cochlea, manually or robot-assisted(medium speed and low speed). The real-time force during electrode array insertion was recorded by ATI Nano 17 Ti sensors and was analyzed by accessory software. Origin 2020b software was used for statistical processing. Results: The insertion force of all electrode arrays progressively increased with the insertion depth. With the manual technique, the peak force of slim-medium electrode insertion was significantly smaller than that of the standard electrode insertion((71.0±16.6) mN vs (140.9±52.7) mN, Z=3.683, P<0.01), and the peak force of the slim-long electrode insertion was between the peak force of standard electrode and slim-medium electrode(P>0.05). No difference was found in the force variation of insertion among the three electrodes(P>0.05). With medium-speed and low-speed robotic assistance, the peak force characteristics of three electrodes were similar to those with the manual technique, but the force variation of standard electrode insertion ((83.9±9.7) mN/s) at medium speed was significantly larger than that of the slim-long electrode insertion ((69.2±4.0)mN/s), and the force variation of the standard electrode insertion at low speed was significantly greater than the other two electrodes. For the same electrode, robot-assisted insertion presented significantly lower peak force and force variation than manual insertion for each type of electrode array. But there was no difference in the peak force and force variation between two-speed levels of robot assistance (P>0.05). Conclusions: The insertion force of the electrode array will be lower when a slim electrode array or robot technique is applied. Long electrode array might make manual insertion difficult or less precise. Robot assistance has advantage on force control during electrode array insertion.

Robot-Assisted Electrode Array Insertion Becomes Available in Pediatric Cochlear Implant Recipients: First Report and an Intra-Individual Study.

Background: As an advanced surgical technique to reduce trauma to the inner ear, robot-assisted electrode array (EA) insertion has been applied in adult cochlear implantation (CI) and was approved as a safe surgical procedure that could result in better outcomes. As the mastoid and temporal bones are generally smaller in children, which would increase the difficulty for robot-assisted manipulation, the clinical application of these systems for CI in children has not been reported. Given that the pediatric candidate is the main population, we aim to investigate the safety and reliability of robot-assisted techniques in pediatric cochlear implantation.Methods: Retrospective cohort study at a referral center in Shanghai including all patients of simultaneous bilateral CI with robotic assistance on one side (RobOtol® system, Collin ORL, Bagneux, France), and manual insertion on the other (same brand of EA and CI in both side), from December 2019 to June 2020. The surgical outcomes, radiological measurements (EA positioning, EA insertion depth, mastoidectomy size), and audiological outcomes (Behavior pure-tone audiometry) were evaluated.Results: Five infants (17.8 ± 13.5 months, ranging from 10 to 42 months) and an adult (39 years old) were enrolled in this study. Both perimodiolar and lateral wall EAs were included. The robot-assisted EA insertion was successfully performed in all cases, although the surgical zone in infants was about half the size in adults, and no difference was observed in mastoidectomy size between robot-assisted and manual insertion sides (p = 0.219). The insertion depths of EA with two techniques were similar (P = 0.583). The robot-assisted technique showed no scalar deviation, but scalar deviation occurred for one manually inserted pre-curved EA (16%). Early auditory performance was similar to both techniques.Conclusion: Robot-assisted technique for EA insertion is approved to be used safely and reliably in children, which is possible and potential for better scalar positioning and might improve long-term auditory outcome. Standard mastoidectomy size was enough for robot-assisted technique. This first study marks the arrival of the era of robotic CI for all ages.

A three-dimensional thermal model of the human cochlea for magnetic cochlear implant surgery

In traditional cochlear implant surgery, physical trauma may occur during electrode array insertion. Magnetic guidance of the electrode array has been proposed to mitigate this medical complication. After insertion, the guiding magnet attached to the tip of the electrode array must be detached via a heating process and removed. This heating process may, however, cause thermal trauma within the cochlea. In this study, a validated three-dimensional finite element heat transfer model of the human cochlea is applied to perform an intracochlear thermal analysis necessary to ensure the safety of the magnet removal phase. Specifically, the maximum safe input power density to detach the magnet is determined as a function of the boundary conditions, heating duration, cochlea size, implant electrode array radius and insertion depth, magnet size, and cochlear fluid. A dimensional analysis and numerical simulations reveal that the maximum safe input power density increases with increasing cochlea size and the radius of the electrode array, whereas it decreases with increasing electrode array insertion depth and magnet size. The best cochlear fluids from the thermal perspective are perilymph and a soap solution. Even for the worst case scenario in which the cochlear walls are assumed to be adiabatic except at the round window, the maximum safe input power density is larger than that required to melt 1 mm3 of paraffin bonding the magnet to the implant electrode array. By combining the outcome of this work with other aspects of the design of the magnetic insertion process, namely the magnetic guidance procedure and medical requirements, it will be possible to implement a thermally safe patient-specific surgical procedure.

Estimating the Pose of a Guinea-pig Cochlea Without Medical Imaging.

The pose (i.e., position and orientation) of a guinea-pig cochlea can be accurately estimated using externally observable features, without requiring computed-tomography (CT) scans. Guinea pigs are frequently used in otologic research as animal models of cochlear-implant surgery. In robot-assisted surgical insertion of cochlear-implant electrode arrays, knowing the cochlea pose is required. A preoperative CT scan of the guinea-pig anatomy can be labeled and registered to the surgical system, however, this process can be expensive and time consuming. Anatomical features from both sides of 11 guinea-pig CT scans were labeled and registered, forming sets. Using a groupwise point-set registration algorithm, errors in cochlea position and modiolar-axis orientation were estimated for 11 iterations of registration where each feature set was used as a hold-out set containing a reduced number of features that could all be touched by a motion-tracking probe intraoperatively. The method was validated on 2000 simulated guinea-pig cochleae and six physical guinea-pig-skull cochleae. Validation on simulated cochleae resulted in cochlea-position estimates with a maximum error of 0.43 mm and modiolar-axis orientation estimates with a maximum error of 8.1 degrees for 96.7% of cochleae. Physical validation resulted in cochlea-position estimates with a maximum error of 0.80 mm and modiolar-axis orientation estimates with a maximum error of 12.4 degrees. This work enables researchers conducting robot-assisted surgical insertions of cochlear-implant electrode arrays using a guinea-pig animal model to estimate the pose of a guinea-pig cochlea by locating six externally observable features on the guinea pig, without the need for CT scans.

Laser ablation of the pia mater for insertion of high-density microelectrode arrays in a translational sheep model

Objective. The safe insertion of high density intracortical electrode arrays has been a long-standing practical challenge for neural interface engineering and applications such as brain–computer interfaces (BCIs). However, the pia mater can be difficult to penetrate and causes deformation of underlying cortical tissue during insertion of high-density intracortical arrays. This can lead to neuron damage or failed insertions. The development of a method to ease insertion through the pia mater would represent a significant step toward inserting high density intracortical arrays. Approach. Here we describe a surgical procedure, inspired by laser corneal ablation, that can be used in translational models to thin the pia mater. Main results. We demonstrate that controlled pia removal with laser ablation over a small area of cortex allows for microelectrode arrays to be inserted into the cortex with less force, thus reducing deformation of underlying tissue during placement of the microelectrodes. This procedure allows for insertion of high-density electrode arrays and subsequent acute recordings of spiking neuron activity in sheep cortex. We also show histological and electrophysiological evidence that laser removal of the pia does not acutely affect neuronal viability in the region. Significance. Laser ablation of the pia reduces insertion forces of high-density arrays with minimal to no acute damage to cortical neurons. This approach suggests a promising new path for clinical BCI with high-density microelectrode arrays.

Magnetic Steering of Robotically Inserted Lateral-wall Cochlear-implant Electrode Arrays Reduces Forces on the Basilar Membrane In Vitro.

Undesirable forces applied to the basilar membrane during surgical insertion of lateral-wall cochlear-implant electrode arrays (EAs) can be reduced via robotic insertion with magnetic steering of the EA tip. Robotic insertion of magnetically steered lateral-wall EAs has been shown to reduce insertion forces in vitro and in cadavers. No previous study of robot-assisted insertion has considered force on the basilar membrane. Insertions were executed in an open-channel scala-tympani phantom. A force plate, representing the basilar membrane, covered the channel to measure forces in the direction of the basilar membrane. An electromagnetic source generated a magnetic field to steer investigational EAs with permanent magnets at their tips, while a robot performed the insertion. When magnetic steering was sufficient to pull the tip of the EA off of the lateral wall of the channel, it resulted in at least a 62% reduction of force on the phantom basilar membrane at insertion depths beyond 14.4 mm (p < 0.05), and these beneficial effects were maintained beyond approximately the same depth, even with 10 degrees of error in the estimation of the modiolar axis of the cochlea. When magnetic steering was not sufficient to pull the EA tip off of the lateral wall, a significant difference from the no-magnetic-steering case was not found. This in vitro study suggests that magnetic steering of robotically inserted lateral-wall cochlear-implant EAs, given sufficient steering magnitude, can reduce forces on the basilar membrane in the first basilar turn compared with robotic insertion without magnetic steering.

Clinical Translation of an Insertion Tool for Minimally Invasive Cochlear Implant Surgery.

The objective of this paper is to describe the development of a minimally invasive cochlear implant surgery (MICIS) electrode array insertion tool concept to enable clinical translation. First, analysis of the geometric parameters of potential MICIS patients (N = 97) was performed to inform tool design, inform MICIS phantom model design, and provide further insight into MICIS candidacy. Design changes were made to the insertion tool based on clinical requirements and parameter analysis results. A MICIS phantom testing model was built to evaluate insertion force profiles in a clinically realistic manner, and the new tool design was evaluated in the model and in cadavers to test clinical viability. Finally, after regulatory approval, the tool was used for the first time in a clinical case. Results of this work included first, in the parameter analysis, approximately 20% of the population was not considered viable MICIS candidates. Additionally, one 3D printed tool could accommodate all viable candidates with polyimide sheath length adjustments accounting for interpatient variation. The insertion tool design was miniaturized out of clinical necessity and a disassembly method, necessary for removal around the cochlear implant, was developed and tested. Phantom model testing revealed that the force profile of the insertion tool was similar to that of traditional forceps insertion. Cadaver testing demonstrated that all clinical requirements (including complete disassembly) were achieved with the tool, and the new tool enabled 15% deeper insertions compared to the forceps approach. Finally, and most importantly, the tool helped achieve a full insertion in its first MICIS clinical case. In conclusion, the new insertion tool provides a clinically viable solution to one of the most difficult aspects of MICIS.

The Sensitivity of the Electrically Stimulated Auditory Nerve to Amplitude Modulation Cues Declines With Advanced Age.

This study aimed to investigate effects of aging and duration of deafness on sensitivity of the auditory nerve (AN) to amplitude modulation (AM) cues delivered using trains of biphasic pulses in adult cochlear implant (CI) users. There were 21 postlingually deaf adult CI users who participated in this study. All study participants used a Cochlear Nucleus device with a full electrode array insertion in the test ear. The stimulus was a 200-ms pulse train with a pulse rate of 2000 pulses per second. This carrier pulse train was sinusodially AM at four modulation rates (20, 40, 100, 200 Hz). The peak amplitude of the modulated pulse train was the maximum comfortable level (i.e., C level) measured for the carrier pulse train. The electrically evoked compound action potential (eCAP) to each of the 20 pulses selected over the last two AM cycles were measured. In addition, eCAPs to single pulses were measured with the probe levels corresponding to the levels of 20 selected pulses from each AM pulse train. There were seven electrodes across the array evaluated in 16 subjects (i.e., electrodes 3 or 4, 6, 9, 12, 15, 18, and 21). For the remaining five subjects, 4 to 5 electrodes were tested due to impedance issues or time constraints. The modulated response amplitude ratio (MRAR) was calculated as the ratio of the difference in the maximum and the minimum eCAP amplitude measured for the AM pulse train to that measured for the single pulse, and served as the dependent variable. Age at time of testing and duration of deafness measured/defined using three criteria served as the independent variables. Linear Mixed Models were used to assess the effects of age at testing and duration of deafness on the MRAR. Age at testing had a strong, negative effect on the MRAR. For each subject, the duration of deafness varied substantially depending on how it was defined/measured, which demonstrates the difficulty of accurately measuring the duration of deafness in adult CI users. There was no clear or reliable trend showing a relationship between the MRAR measured at any AM rate and duration of deafness defined by any criteria. After controlling for the effect of age at testing, MRARs measured at 200 Hz and basal electrode locations (i.e., electrodes 3 and 6) were larger than those measured at any other AM rate and apical electrode locations (i.e., electrodes 18 and 21). The AN sensitivity to AM cues implemented in the pulse-train stimulation significantly declines with advanced age. Accurately measuring duration of deafness in adult CI users is challenging, which, at least partially, might have accounted for the inconclusive findings in the relationship between the duration of deafness and the AN sensitivity to AM cues in this study.

EAS-Combined electric and acoustic stimulation

Electric-acoustic stimulation (EAS) is a special treatment modality for those patients who are profoundly deaf in the high-frequency (HF) region and retain usable hearing in the low-frequency (LF) region. Combining the electric stimulation with cochlear implant (CI) in the HF and acoustic amplification of residual hearing using a conventional hearing aid (HA) in the LF region defines EAS. The EAS concept was first proposed by C. von Ilberg from Frankfurt, Germany in the year 1997. In association with MED-EL, all the necessary safety studies were performed in non-human subjects before the first patient received it in 1997. In association with MED-EL, all the necessary safety studies were performed in non-human subjects before the first patient received it in 1999. For the patient to successfully use the EAS concept, the residual hearing needs to be preserved to a high extent and for several years. This requires a highly flexible electrode array in safeguarding the intra-cochlear structures during and after the CI electrode array insertion. Combining the HA unit with the audio processor unit of the CI was necessary for the convenient wearing of the unified audio processor. Fitting of the unified audio processor is another important factor that contributes to the overall success of the EAS treatment. The key translational research efforts at MED-EL were on the development of flexible electrodes, a unified audio processor, innovations in the fitting process, intra-operative monitoring of cochlear health during electrode insertion, pre-operative soft-ware tool to evaluate the cochlear size and electrode selection and some new innovations tried within EAS topic. This article covers the milestones of translational research from the first concept to the widespread clinical use of EAS.

Insertion trauma of a new cochlear implant electrode: evaluated by histology in fresh human temporal bone specimens

Background Combining acoustic and electrical stimulation has been successfully used in patients with low-frequency residual hearing. Electrode insertion trauma, such as electrode translocation could result in loss of residual hearing. Objectives The aim of the study is to evaluate the LCI-20PI electrode array insertion trauma to the intra-cochlear structures in fresh human temporal bone specimens. Materials and methods The LCI-20PI electrode arrays were inserted into scalae tympani through round window membrane in 10 cochleae from ten fresh human cadavers. The intracochlear trauma was evaluated histologically by a scale of 0–4: 0 – no observable trauma, 1 – elevation of basilar membrane, 2 – rupture of basilar membrane or spiral ligament, 3–dislocation into scala vestibuli and 4 – fracture of modiolus or osseous spiral lamina. The insertion depth was measured by radiography. Results Histological results revealed no observable trauma in seven specimens; basal membrane elevation and rupture in two specimens; the electrode array misled into scala vestibuli in one specimen. The insertion depth varied from 228° to 288°. Conclusions and significance The insertion of the LCI-20PI electrode arrays caused no trauma in the majority of the fresh temporal bone specimens. No translocation of the electrode arrays from the scala tympani to the scala vestibuli was observed.

Sheep as a large animal model for cochlear implantation

IntroductionIn surgical training, large animal models are more suitable as their anatomy is more similar to humans. In otology, there have been relatively few studies about large animal models for surgical training. ObjectiveIn this study, we aimed to do a neuroradiologic evaluation and surgical insertion of a cochlear implant electrode array on a sheep head model. MethodsTwenty cadaveric sheep heads were studied. A computed tomography scan and neuroradiologic evaluation was performed on each head, obtaining measurements of the inner ear for each sheep. Sheep measurements were compared to those from temporal bone computed tomography scans from 20 female humans. Surgical procedures were first trained with 13 of the sheep temporal bones, after which cochlear implantation was performed on the remaining 7 temporal bones. The position of the inserted electrode array insertion was confirmed by computed tomography scan after the procedure. ResultsNeuroradiologic evaluation showed that, relative to the 20 female humans, the mean ratio for sheep was 0.60 for volume of cochlea, 0.70 for height of cochlea, 0.73 for length of cochlea; ratios for other metrics were >0.80. For the surgical training, the round window was found in all 20 sheep temporal bones. Computed tomography scans confirmed that electrode insertions were fully complete; the mean value of electrode array insertion was 18.3 mm. ConclusionThe neuroradiologic and surgical training data suggest that the sheep is a realistic animal model to train cochlear implant surgery and collection of perilymph samples, but less so for surgical training of mastoidectomy due to pneumatization of the mastoid.

Fabrication of human anatomy-based scala tympani models with a hydrophilic coating for cochlear implant insertion experiments

Electrode array insertion into the inner ear is a critical step in cochlear implantation, and artificial scala tympani models can be a valuable tool for studying the dynamics of this process.This technical note describes the fabrication of electrode array dummies and scala tympani models that address shortcomings of previously published cochlear models. In particular, we improve the reproduction of frictional properties with an easy-to-apply polymer brush coating that creates hydrophilic surfaces, and produce geometries with accurate macro-anatomy based on microtomographic scans. The presented methods rely only on commonly available materials and tools and are based on publicly available data.Our validation shows very good agreement of insertion forces both in terms of linear insertion depth and insertion speed compared to previously published measurements of insertions in cadaveric temporal bones.