Intracochlear Recording of Electrocochleography During and After Cochlear Implant Insertion Dependent on the Location in the Cochlea.

To preserve residual hearing during cochlear implant (CI) surgery it is desirable to use intraoperative monitoring of inner ear function (cochlear monitoring). A promising method is electrocochleography (ECochG). Within this project the relations between intracochlear ECochG recordings, position of the recording contact in the cochlea with respect to anatomy and frequency and preservation of residual hearing were investigated. The aim was to better understand the changes in ECochG signals and whether these are due to the electrode position in the cochlea or to trauma generated during insertion. During and after insertion of hearing preservation electrodes, intraoperative ECochG recordings were performed using the CI electrode (MED-EL). During insertion, the recordings were performed at discrete insertion steps on electrode contact 1. After insertion as well as postoperatively the recordings were performed at different electrode contacts. The electrode location in the cochlea during insertion was estimated by mathematical models using preoperative clinical imaging, the postoperative location was measured using postoperative clinical imaging. The recordings were analyzed from six adult CI recipients. In the four patients with good residual hearing in the low frequencies the signal amplitude rose with largest amplitudes being recorded closest to the generators of the stimulation frequency, while in both cases with severe pantonal hearing losses the amplitude initially rose and then dropped. This might be due to various reasons as discussed in the following. Our results indicate that this approach can provide valuable information for the interpretation of intracochlearly recorded ECochG signals.

First clinical implementation of insertion force measurement in cochlear implantation surgery.

Purpose: The significance of atraumatic electrode array (EA) insertion in cochlear implant (CI) surgery is widely acknowledged, with consensus that forces due to EA insertion are directly correlated with insertion trauma. Unfortunately, the manual perception of these forces through haptic feedback is inherently limited, and techniques for in vivo force measurements to monitor the insertion are not yet available. Addressing this gap, we developed of a force-sensitive insertion tool capable of capturing real-time insertion forces during standard CI surgery. Methods: This paper describes the tool and its pioneering application in a clinical setting and reports initial findings from an ongoing clinical study. Data and experiences from five patients have been evaluated so far, including force profiles of four patients. Results: The initial intraoperative experiences are promising, with successful integration into the conventional workflow. Feasibility of in vivo insertion force measurement and practicability of the tool's intraoperative use could be demonstrated. The recorded in vivo insertion forces show the expected rise with increasing insertion depth. Forces at the end of insertion range from 17.2 mN to 43.6 mN, while maximal peak forces were observed in the range from 44.8 mN to 102.4 mN. Conclusion: We hypothesize that this novel method holds the potential to assist surgeons in monitoring the insertion forces and, thus, minimizing insertion trauma and ensuring better preservation of residual hearing. Future data recording with this tool can form the basis of ongoing research into the causes of insertion trauma, paving the way for new and improved prevention strategies.

Long-Term Hearing Outcome of Cochlear Implantation in Cases with Simultaneous Intracochlear Schwannoma Resection.

OBJECTIVES: The aim was to analyze the long-term hearing results after simultaneous microsurgical extirpation via enlarged cochleostomy and cochlear implantation in intracochlear schwannoma as compared with non-tumor single-side deafness patients. METHODS: Microsurgical extirpation via enlarged cochleostomy with simultaneous cochlear implantation was performed in 15 cases of intracochlear schwannoma between 2014 and 2021. Speech recognition tests in German language and impedance performances were collected over 36 months of observation and compared with an internal cohort of 52 age matched non-tumor single-side deafness patients. Retrospective cohort study in a tertiary referral center. RESULTS: The surgery proved feasible and uneventful in all cases. In the case of intracochlear schwannoma, the hearing rehabilitation results were highly satisfactory and comparable to those of the non-tumor single-side deafness cohort. The speech recognition performance improved steadily in the first 12 months; afterward, it remained stable, providing indirect evidence against tumor recurrence during the follow-up. One patient required implant revision surgery related to device failure, but no recurrence was registered in the 36 months of observation. CONCLUSIONS: Cochlear implantation is the strategy of choice for hearing rehabilitation in case of intracochlear schwannomas in the long term. In particular, the combination of tumor extirpation via cochleostomy with a cochlear implantation in the same surgical time offers a viable therapy for intracochlear schwannoma, granting a sufficient degree of radicality without compromising the cochlear integrity. This technique allows for revision surgery if required. LEVEL OF EVIDENCE: 4 Laryngoscope, 134:1854-1860, 2024.

Deep intracochlear injection of triamcinolone-acetonide with an inner ear catheter in patients with residual hearing.

Introduction: In a previous study, an inner ear catheter was used to deliver low- and high-dose steroids into the cochlea prior to cochlear implant electrode insertion. With this approach, more apical regions of the cochlea could be reached and a reduction of electrode impedances in the short term was achieved in cochlear implant recipients. Whether intracochlear application of drugs via the catheter is a safe method also for patients with residual hearing has not been investigated hitherto. The aim of the present study was therefore to investigate the effect of intracochlear triamcinolone application in cochlear implant recipients with residual hearing. Patients and methods: Patients with residual hearing were administered triamcinolone-acetonide (4 mg/ml; n = 10) via an inner ear catheter just prior to insertion of a MED-EL FLEX28 electrode. Impedances were measured at defined time points (intra-operatively, post-operatively and at first fitting) and retrospectively compared with a control group (no steroid application) and low- and high-dose group. Hearing thresholds were measured preoperatively, 3 days after surgery and at first fitting by pure tone audiometry. Pre- to postoperative hearing loss was determined at first fitting and compared to results from a previous study. Results: The median hearing loss after implantation (125-1,500 Hz) was 20.6 dB. Four patients (40%) showed a median hearing loss of less than 15 dB, three patients (30%) between 15 and 30 dB and three patients (30%) more than 30 dB. The median hearing loss was similar to the results obtained from our previous study showing a median hearing loss of 24 dB when using FLEX28 electrode arrays. Conclusion: No difference in residual hearing loss was found when comparing application of triamcinolone-acetonide using an inner ear catheter prior to the insertion of a FLEX28 electrode array to the use of the FLEX28 electrode array without the catheter. Thus, we conclude that application of drugs to the cochlea with an inner ear catheter could be a feasible approach in patients with residual hearing.

Preclinical evaluation of a tool for insertion force measurements in cochlear implant surgery.

PURPOSE: Trauma that may be inflicted to the inner ear (cochlea) during the insertion of an electrode array (EA) in cochlear implant (CI) surgery can significantly decrease the hearing outcome of patients with residual hearing. Interaction forces between the EA and the cochlea are a promising indicator for the likelihood of intracochlear trauma. However, insertion forces have only been measured in laboratory setups. We recently developed a tool to measure the insertion force during CI surgery. Here, we present the first ex vivo evaluation of our tool with a focus on usability in the standard surgical workflow. METHODS: Two CI surgeons inserted commercially available EAs into three temporal bone specimens. The insertion force and the orientation of the tool were recorded together with camera footage. The surgeons answered a questionnaire after each insertion to evaluate the surgical workflow with respect to CI surgery. RESULTS: The EA insertion using our tool was rated successful in all 18 trials. The surgical workflow was evaluated to be equivalent to standard CI surgery. Minor handling challenges can be overcome through surgeon training. The peak insertion forces were 62.4 mN ± 26.7 mN on average. Peak forces significantly correlated to the final electrode insertion depth, supporting the assumption that the measured forces mainly correspond to intracochlear events and not extracochlear friction. Gravity-induced forces of up to 28.8 mN were removed from the signal, illustrating the importance of the compensation of such forces in manual surgery. CONCLUSION: The results show that the tool is ready for intraoperative use. In vivo insertion force data will improve the interpretability of experimental results in laboratory settings. The implementation of live insertion force feedback to surgeons could further improve residual hearing preservation.

Estimating vibration artifacts in preclinical experimental assessment of actuator efficiency in bone-conduction hearing devices.

OBJECTIVES: Test feasibility of a means to distinguish artifact from relevant signal in an experimental method for pre-clinical assessment of bone conduction (BC) stimulation efficiency based on measurement of intracochlear pressure (ICP). METHODS: Experiments were performed on fresh-frozen human temporal bones and cadaver heads. In a first step, fiber optic pressure sensors inserted into the cochlea through cochleostomies were intentionally vibrated to generate relative motion versus the stationary specimen, and the resulting ICP artifact recorded, before and after attaching the sensor fiber to the bone with glue. In a second step, BC stimulation was applied in the conventional location for a commercial bone anchored implant, as well as two alternative locations closer to the otic capsule. Again, ICP was recorded and compared with an estimated artifact, calculated from the previous measurements with intentional vibration of the fiber. RESULTS: Intentional vibration of the sensor fiber creates relative motion between fiber and bone, as intended, and causes an ICP signal. The stimulus does not create substantial promontory vibration, indicating that the measured ICP is all artifact, i.e. would not occur if the sensor were not in place. Fixating the sensor fiber to the bone with glue reduces the ICP artifact by at least 20 dB. BC stimulation also creates relative motion between sensor fiber and bone, as expected, from which an estimated ICP artifact level can be calculated. The ICP signal measured during BC stimulation is well above the estimated artifact, at least in some specimens and at some frequencies, indicating "real" cochlear stimulation, which would result in an auditory percept in a live subject. Stimulation at the alternative locations closer to the otic capsule appear to result in higher ICP (no statistical analysis performed), indicating a trend towards more efficient stimulation than at the conventional location. CONCLUSIONS: Intentional vibration of the fiber optic sensor for measurement of ICP can be used to derive an estimate of the artifact to be expected when measuring ICP during BC stimulation, and to characterize the effectiveness of glues or other means of reducing the artifact caused by relative motion of fiber and bone.

Multicentric study on surgical information and early safety and performance results with the Bonebridge BCI 602: an active transcutaneous bone conduction hearing implant.

AIM: This European multicentric study aimed to prove safety and performance of the Bonebridge BCI 602 in children and adults suffering from either conductive hearing loss (CHL), mixed hearing loss (MHL), or single-sided sensorineural deafness (SSD). METHODS: 33 patients (13 adults and 10 children with either CHL or MHL and 10 patients with SSD) in three study groups were included. Patients were their own controls (single-subject repeated measures), comparing the unaided or pre-operative to the 3-month post-operative outcomes. Performance was evaluated by sound field thresholds (SF), word recognition scores (WRS) and/or speech reception thresholds in quiet (SRT) and in noise (SNR). Safety was demonstrated with a device-specific surgical questionnaire, adverse event reporting and stable pure-tone measurements. RESULTS: The Bonebridge BCI 602 significantly improved SF thresholds (+ 25.5 dB CHL/MHL/SSD), speech intelligibility in WRS (+ 68.0% CHL/MHL) and SRT in quiet (- 16.5 dB C/MHL) and in noise (- 3.51 dB SNR SSD). Air conduction (AC) and bone conduction (BC) thresholds remained stable over time. All adverse events were resolved, with none unanticipated. Mean audio processor wearing times in hours [h] per day for the CHL/MHL group were ~ 13 h for adults, ~ 11 h for paediatrics and ~ 6 h for the SSD group. The average surgical length was 57 min for the CHL/MHL group and 42 min for the SSD group. The versatility of the BCI 602 (reduced drilling depth and ability to bend the transition for optimal placement) allows for treatment of normal, pre-operated and malformed anatomies. All audiological endpoints were reached. CONCLUSIONS: The Bonebridge BCI 602 significantly improved hearing thresholds and speech understanding. Since implant placement follows the patient's anatomy instead of the shape of the device and the duration of surgery is shorter than with its predecessor, implantation is easier with the BCI 602. Performance and safety were proven for adults and children as well as for the CHL/MHL and SSD indications 3 months post-operatively.

Cochlear Implantation in Obliterated Cochlea: A Retrospective Analysis and Comparison between the IES Stiff Custom-Made Device and the Split-Array and Regular Electrodes.

Anatomical malformations, obliterations of the cochlea, or re-implantations pose particular challenges in cochlear implantation. Treatment methods rely on radiological and intraoperative findings and include incomplete insertion, the implantation of a double array, and radical cochleostomy. In addition, a stiff electrode array, e.g., the IE stiff (IES) custom-made device (CMD, MED-EL), was prescribed individually for those special cases and pre-inserted prior to facilitate cochlear implantation in challenging cases. Data on outcomes after implantation in obliterated cochleae are usually based on individual case reports since standardised procedures are lacking. A retrospective analysis was conducted to analyse our cases on obliterated cochleae treated with MED-EL devices in order to allow the different cases to be compared. Impedances and speech perception data of patients treated with the IES CMD and the double array were retrospectively compared to patients treated with a STANDARD or FLEX electrode array (the REGULAR group). Patients with a Split-Array CMD had a poor speech perception when compared to patients treated with the IES CMD device. Thus, the IES CMD can successfully be used in patients with obliterated cochleae who would otherwise be non-users, candidates for a Split-Array CMD, or candidates for partial insertion with insufficient cochlear coverage.

Can Electrocochleography Help Preserve Hearing After Cochlear Implantation With Full Electrode Insertion?

OBJECTIVES: To evaluate the utility of intracochlear electrocochleography (ECochG) monitoring during cochlear implant (CI) surgery on postoperative hearing preservation. STUDY DESIGN: Prospective, randomized clinical trial. SETTING: Ten high-volume, tertiary care CI centers. PATIENTS: Adult patients with sensorineural hearing loss meeting the CI criteria who selected an Advanced Bionics CI. METHODS: Patients were randomized to CI surgery either with audible ECochG monitoring available to the surgeon during electrode insertion or without ECochG monitoring. Hearing preservation was determined by comparing preoperative unaided low-frequency (125-, 250-, and 500-Hz) pure-tone average (LF-PTA) to postoperative LF-PTA at CI activation. Pre- and post-CI computed tomography was used to determine electrode scalar location and electrode translocation. RESULTS: Eighty-five adult CI candidates were enrolled. The mean (standard deviation [SD]) unaided preoperative LF-PTA across the sample was 54 (17) dB HL. For the whole sample, hearing preservation was "good" (i.e., LF-PTA change 0-15 dB) in 34.5%, "fair" (i.e., LF-PTA change >15-29 dB) in 22.5%, and "poor" (i.e., LF-PTA change ≥30 dB) in 43%. For patients randomized to ECochG "on," mean (SD) LF-PTA change was 27 (20) dB compared with 27 (23) dB for patients randomized to ECochG "off" ( p = 0.89). Seven percent of patients, all of whom were randomized to ECochG off, showed electrode translocation from the scala tympani into the scala vestibuli. CONCLUSIONS: Although intracochlear ECochG during CI surgery has important prognostic utility, our data did not show significantly better hearing preservation in patients randomized to ECochG "on" compared with ECochG "off."

Minimally Invasive Cochlear Implantation: First-in-Man of Patient-Specific Positioning Jigs.

A minimally-invasive surgical (MIS) approach to cochlear implantation, if safe, practical, simple in surgical handling, and also affordable has the potential to replace the conventional surgical approaches. Our MIS approach uses patient-specific drilling templates (positioning jigs). While the most popular MIS approaches use robots, the robotic aspect is literally put aside, because our high-precision parallel kinematics is only used to individualize a positioning jig. This jig can then be mounted onto a bone-anchored mini-stereotactic frame at the patient's skull and used to create a drill-hole through the temporal bone to the patient's cochlea. We present the first clinical experience where we use sham drill bits of different diameters instead of drilling into the bone in order to demonstrate the feasibility and accuracy.

Clinical experiences with intraoperative electrocochleography in cochlear implant recipients and its potential to reduce insertion trauma and improve postoperative hearing preservation.

Access to low-frequency acoustic information in cochlear implant patients leads to better speech understanding in noise. Electrocochleography (ECochG) can provide real-time feedback about the health of the cochlea during the insertion process with the potential to reduce insertion trauma. We describe our experiences of using this technique. Data from 47 adult subjects with measurable residual hearing and an Advanced Bionics (Valencia, CA) SlimJ (46) or MidScala (1) electrode array were analyzed. ECochGs were recorded intraoperatively via the implant. The surgeon adjusted the course of the electrode insertion based on drops in the ECochG. The final array position was assessed using postoperative imaging and pure tone thresholds were measured before and after surgery. Three different patterns of ECochG response amplitude were observed: Growth, Fluctuating and Total Loss. Subjects in the growth group showed the smallest postoperative hearing loss. However, the group with fluctuating amplitudes showed no meaningful correlation between the ECochG responses and the postoperative hearing loss, indicating that amplitude alone is insufficient for detecting damage. Considering the phase of the signal additionally to the amplitude and reclassifying the data by both the phase and amplitude of the response into three groups Type I-Type III produced statistically significant correlations between postoperative hearing loss and the grouping based on amplitude and phase respectively. We showed significantly better hearing preservation for Type I (no drop in amplitude) and Type II (drop with a concurrent phase shift), while Type III (drop without concurrent phase shift) had more surgery induced hearing loss. ECochG potentials measured through the implant could provide valuable feedback during the electrode insertion. Both the amplitude and phase of the ECochG response are important to consider. More data needs to be evaluated to better understand the impact of the different signal components to design an automated system to alert the surgeon ahead of damaging the cochlea.

Variations in microanatomy of the human modiolus require individualized cochlear implantation.

Cochlear variability is of key importance for the clinical use of cochlear implants, the most successful neuroprosthetic device that is surgically placed into the cochlear scala tympani. Despite extensive literature on human cochlear variability, few information is available on the variability of the modiolar wall. In the present study, we analyzed 108 corrosion casts, 95 clinical cone beam computer tomographies (CTs) and 15 µCTs of human cochleae and observed modiolar variability of similar and larger extent than the lateral wall variability. Lateral wall measures correlated with modiolar wall measures significantly. ~ 49% of the variability had a common cause. Based on these data we developed a model of the modiolar wall variations and related the model to the design of cochlear implants aimed for perimodiolar locations. The data demonstrate that both the insertion limits relevant for lateral wall damage (approximate range of 4-9 mm) as well as the dimensions required for optimal perimodiolar placement of the electrode (the point of release from the straightener; approximate range of 2-5mm) are highly interindividually variable. The data demonstrate that tip fold-overs of preformed implants likely result from the morphology of the modiolus (with radius changing from base to apex), and that optimal cochlear implantation of perimodiolar arrays cannot be guaranteed without an individualized surgical technique.

Analysis of deep grey nuclei susceptibility in early childhood: a quantitative susceptibility mapping and R2* study at 3 Tesla.

PURPOSE: Aging is the most significant determinant for brain iron accumulation in the deep grey matter. Data on brain iron evolution during brain maturation in early childhood are limited. The purpose of this study was to investigate age-related iron deposition in the deep grey matter in children using quantitative susceptibility (QSM) and R2* mapping. METHODS: We evaluated brain MRI scans of 74 children (age 6-154 months, mean 40 months). A multi-echo gradient-echo sequence obtained at 3 Tesla was used for the QSM and R2* calculation. Susceptibility of the pallidum, head of caudate nucleus, and putamen was correlated with age and compared between sexes. RESULTS: Susceptibility changes in all three nuclei correlated with age (correlation coefficients for QSM/R2*: globus pallidus 0.955/0.882, caudate nucleus 0.76/0.65, and putamen 0.643/0.611). During the first 2 years, the R2* values increased more rapidly than the QSM values, indicating a combined effect of iron deposition and myelination, followed by a likely dominating effect of iron deposition. There was no significant gender difference. CONCLUSION: QSM and R2* can monitor myelin maturation processes and iron accumulation in the deep grey nuclei of the brain in early life and may be a promising tool for the detection of deviations of this normal process. Susceptibility in the deep nuclei is almost similar early after birth and increases more quickly in the pallidum. The combined use of QSM and R2* analysis is beneficial.

Output performance of the novel active transcutaneous bone conduction implant Sentio at different stimulation sites.

OBJECTIVES: The output performance of a novel semi-implantable transcutaneous bone conduction device was compared to an established percutaneous bone-anchored hearing system device using cadaver heads. The influence of actuator position, tissue growth below the actuator and mounting it on the surface or in a flattened bone bed on the performance of the implanted actuator was investigated. MATERIALS AND METHODS: The percutaneous and the new transcutaneous device were sequentially implanted at two sites in five human cadaver heads: 55 mm superior-posterior to the ear canal opening (position A) and, closer to the cochlea, about 20 mm inferior-posterior to the ear canal opening behind the pinna on the mastoid (position B). The ipsi- and contralateral cochlear promontory (CP) velocity magnitude responses to percutaneous and transcutaneous stimulation were measured using laser Doppler vibrometry. In addition, the CP vibration of the transcutaneous device placed directly on the skull bone surface was compared with the placement in a flattened bone bed at a depth of about 3 mm. Finally, the influence of placing a thin silicone interposition layer under the implanted transducer was also explored. RESULTS: The percutaneous device provided about an 11 dB higher average CP vibration level than the transcutaneous device at frequencies between 0.5 and 10 kHz. The ipsilateral CP vibration responses with stimulations at position B were on average 13 dB higher compared to stimulation at position A. The placement of the transcutaneous transducer at position B provided similar or higher average vibration magnitudes than the percutaneous transducer at position A. The 3 mm deep flattened bone bed had no significant effects on the output performance. Placing a thin silicone layer under the transcutaneous transducer had no significant influence on the output of the transcutaneous device. CONCLUSIONS: Our results using the CP vibration responses show that at frequencies above 500 Hz the new transcutaneous device at position B provides similar output levels as the percutaneous device at position A. The results also indicated that neither a bone bed for the placement of the transcutaneous transducer nor a simulated tissue growth between the actuator and the bone affect the output performance of the device.

Long-Term, Multicenter Results With the First Transcutaneous Bone Conduction Implant.

OBJECTIVE: Investigation of long-term safety and performance of an active, transcutaneous bone conduction implant in adults and children up to 36 months post-implantation. STUDY DESIGN: Prospective, single-subject repeated-measures design. SETTING: Otolaryngology departments of eight German and Austrian hospitals.∗†‡§||¶#∗∗†† Affiliations listed above that did not participate in the study.‡‡§§||||¶¶. PATIENTS: Fifty seven German-speaking patients (49 adults and eight children) suffering from conductive or mixed hearing loss, with an upper bone conduction threshold limit of 45 dB HL at frequencies between 500 and 3000 Hz. INTERVENTION: Implantation of the Bonebridge transcutaneous bone conduction hearing implant (tBCI). MAIN OUTCOME MEASURES: Patients' audiometric pure tone averages (PTA4) (0.5, 1, 2, 4 kHz) thresholds (air conduction, bone conduction, and sound field) and speech perception (word recognition scores [WRS] and speech reception thresholds [SRT50%]) were tested preoperatively and up to 36 months postoperatively. Patients were also monitored for adverse events and administered quality-of-life questionnaires. RESULTS: Speech perception (WRS: pre-op: 17.60%, initial activation [IA]: 74.23%, 3M: 83.65%, 12M: 83.46%, 24M: 84.23%, 36M: 84.42%; SRT50%: pre-op: 65.56 dB SPL, IA: 47.67 dB SPL, 3M: 42.61 dB SPL, 12M: 41.11 dB SPL, 24M: 41.74 dB SPL, 36M: 42.43 dB SPL) and sound field thresholds (pre-op: 57.66 dB HL, IA: 33.82 dB HL, 3M: 29.86 dB HL, 12M: 28.40 dB HL, 24M: 28.22 dB HL, 36M: 28.52 dB HL) improved significantly at all aided postoperative visits. Air and bone conduction thresholds showed no significant changes, confirming preservation of patients' residual unaided hearing. All adverse events were resolved by the end of the study. CONCLUSIONS: Safety and performance of the tBCI was demonstrated in children and adults 36 months postoperatively.

On the Intracochlear Location of Straight Electrode Arrays After Cochlear Implantation: How Lateral Are Lateral Wall Electrodes?

OBJECTIVE: Cochlear implants are the gold standard for patients with severe sensorineural hearing loss. A focused electrical stimulation of individual spiral ganglion neurons has not been achieved yet because the scala tympani is a fluid-filled compartment and does not offer a matrix for neuritic outgrowth. Coating of the electrode contacts with swelling hydrogels could fill that gap between the electrode array and the medial wall of the cochlea. Therefore, the exact position of the electrode array within the scala tympani has to be known. STUDY DESIGN: Retrospective analysis of patient data sets. SETTING: Tertiary referral center. A total of 95 patients with cochlear implants from one manufacturer were included in this study. The lateral wall, the modiolar wall, and the cochlear implant electrode were segmented using OsiriX MD. For repositioning and reconstructing the respective contours and measuring distances, files were analyzed in MATLAB. The distances from the edge of each electrode contact to the cochlear walls showed no significant differences. But between the different contacts within each patient, there were significant differences. Around 180 degree insertion, electrodes start to get in contact with the lateral wall. The tip of the electrode array was always facing toward the modiolar wall independent of the length of the electrode. We established a method to analyze the position of electrodes within the cochlea.

A simple tool to automate the insertion process in cochlear implant surgery.

PURPOSE: Automated insertion of electrode arrays (EA) in cochlear implant surgery is presumed to be less traumatic than manual insertions, but no tool is widely available in the operating room. We sought (1) to design and create a simple tool able to automate the EA insertion process; and (2) to perform preliminary evaluations of the designed prototype. METHODS: A first prototype of a tool with maximum simplicity was designed and fabricated to take advantage of hydraulic actuation. The prototype facilitates automated forward motion using a syringe connected to an infusion pump. Initial prototype evaluation included: (1) testing of forward motion at different velocities (2) EA insertion trials into an artificial cochlear model with force recordings, and (3) evaluation of device handling, fixation and positioning using cadaver head specimens and a surgical retractor. Alignment of the tool was explored with CT imaging. RESULTS: In this initial phase, the prototype demonstrated easy assembly and ability to respond to hydraulic actuation driven by an infusion pump at different velocities. EA insertions at an ultra-slow velocity of 0.03 mm/s revealed smooth force profiles with mean maximum force of 0.060 N ± 0.007 N. Device positioning with an appropriate insertion axis into the cochlea was deemed feasible and easy to achieve. CONCLUSIONS: Initial testing of our hydraulic insertion tool did not reveal any serious complications that contradict the initially defined design specifications. Further meticulous testing is needed to determine the safety of the device, its reliability and clinical applicability.

Hearing Preservation With a New Atraumatic Lateral Wall Electrode.

INTRODUCTION: Many individuals have some residual hearing which should be preserved with cochlear implantation. To achieve this goal electrode arrays must fulfil certain design requirements. A new thin lateral wall electrode array (HiFocus SlimJ) was systematically designed on the basis of µCT studies of human cochlea anatomy. The primary objective of this study was to report on initial retrospective hearing preservation results from a cohort of subjects consecutively implanted with this electrode. Secondary objectives were to report on insertion depth and speech perception results for this new array. METHODS: Twenty subjects with considerable residual hearing in low frequencies were consecutively implanted with the SlimJ electrode array. The electrode was inserted slowly through the round window and the insertion process was controlled by intracochlear electrocochleography measuring cochlear microphonics through the cochlear implant.Postoperative cone beam computed tomography was conducted and precise scalar location and angular insertion depth was estimated following image fusion with the preoperative images. RESULTS: Low frequency hearing at 1 month postsurgery was preserved within 30 dB HL in 85% of subjects and within 15 dB HL in 50% of subjects. Mean angular insertion depth was 393 degrees (SD 62 degrees) with a range from 294 to 520 degrees. All electrode contacts in all subjects were identified within scala tympani. CONCLUSION: The SlimJ electrode array is easy to handle for atraumatic insertion through the round window, adjusted insertion depth controlled by electrocochleography measurements, and reliable fixation at the posterior tympanotomy. Hearing preservation rates are encouraging on the short term. We aim to further report on larger data sets and long-term outcomes.

Dose-Dependent Transient Decrease of Impedances by Deep Intracochlear Injection of Triamcinolone With a Cochlear Catheter Prior to Cochlear Implantation-1 Year Data.

Administration of low-dose steroids via a catheter inserted into the cochlea to apply pharmaceuticals to more apical regions was previously shown not to be sufficient for long-term reduction of electrode impedances. The aim of the present study was to investigate the effect of intra-cochlear high-dose triamcinolone application on impedances in cochlear implant recipients. Patients received low-dose (4 mg/ml; n = 5) or high-dose (20 mg/ml; n = 5) triamcinolone via a cochlear catheter just prior to the insertion of a Med-El Flex28 electrode. Impedances were measured at defined time points from intra-operatively up to 12 months after first fitting and retrospectively compared with a control group (no steroid application). Patients who received a high-dose application of crystalloid triamcinolone showed significantly reduced impedances in the first fitting measurements compared to the control group. This effect was no longer detectable in patients of the low-dose group at that time. Looking at the different regions of the electrode, the impedance values were lowered significantly only at the basal and medial contacts. At later time points, there were no significant differences between any of the groups. This is the first study to demonstrate a dose-dependent reduction of impedances by deep intra-cochlear injection of triamcinolone in cochlear implant patients. With a high-dose, single application of triamcinolone using a cochlear catheter prior to insertion of a Flex28 electrode, the impedances can be significantly reduced up to and including the first fitting. Although the effect was longer lasting than when compared to low-dose triamcinolone, it was also not permanent.

First Experience With a New Thin Lateral Wall Electrode in Human Temporal Bones.

INTRODUCTION: A modern cochlear implant electrode array design must combine: improved surgical ease of use, structure preservation, particularly important for pediatric application, stable position within the cochlea over time, and a meaningful balance between hearing preservation against addressing sufficient cochlear tissue to support electrical-only hearing. The aim of this study was to investigate a new lateral wall electrode array design from Advanced Bionics on human temporal bones (TBs). METHODS: Ten fresh-frozen TBs were implanted with the SlimJ electrode array via the round window. The electrode array is 23 mm long, with a cross-section varying from 0.25 × 0.55 mm at the most apical contact to 0.6 × 0.8 mm at the proximal marker contact. To assess location of the electrode array, the TBs were postoperatively scanned using cone beam computed tomography, and histology was performed to assess intracochlear trauma (Grades 0-4). RESULTS: All electrode arrays were considered easy to insert. The average insertion depth was 432 degrees measured from the round window with a range from 411 to 450 degrees azimuth. Nine out of 10 electrode arrays were inserted fully (<0.5 mm out of the cochlea), one electrode array was left 1.5 mm out of the cochlea. No translocations were observed in all 10 cochleae, slight touching of the basilar membrane at the distal portion of the array was observed in 50% of the cases. CONCLUSION: The results from the new thin lateral wall electrode array from Advanced Bionics provided consistent scala tympani locations. No translocations were observed and almost all electrode arrays were fully inserted. These results are promising and the new electrode array will be further studied in clinical practice investigating hearing preservation capabilities and speech performance.