Hypothesis Evaluation of the Slim Modiolar (SM) electrode in temporal bones (TB) will elucidate the electrode's insertion outcomes. Background The SM electrode was designed for atraumatic insertion into the scala tympani, for ideal perimodiolar positioning and with a smaller caliber to minimize interference with cochlear biological processes. Methods The SM electrode was inserted into TBs via a cochleostomy. First, the axial force of insertion was measured. Next, TBs were inserted under fluoroscopy to study insertion dynamics, followed by histologic evaluation of electrode placement and cochlear trauma. A subset of TBs were inserted with the Contour Advance (CA) electrode for comparison. Results Sixteen of 22 insertions performed to measure the axial force of insertion had flat or near zero insertion force profiles. Six insertions had increased insertion forces, which were attributed to improper sheath depth before electrode insertion. Under real-time fluoroscopy, 23 of 25 TBs had uneventful insertion and good perimodiolar placement. There was 1 scala vestibuli insertion due to suboptimal cochleostomy position and 1 tip roll over related to premature electrode deployment. When compared with the CA electrode, 14 of 15 insertions with the SM electrode resulted in a more perimodiolar electrode position. No evidence of trauma was found in histologic evaluation of the 24 TBs with scala tympani insertions. Conclusion TB evaluation revealed that the SM electrode exerts minimal insertion forces on cochlear structures, produces no histologic evidence of trauma, and reliably assumes the perimodiolar position. Nonstandard cochleostomy location, improper sheath insertion depth, or premature deployment of the electrode may lead to suboptimal outcomes.

Objectives Removal of a cochlear implant and its intracochlear electrode array is sometimes necessary, potentially causing cochlear explant trauma. Explantation typically occurs years post-implantation by which time reactive tissue has formed around the electrode. We aimed to create an in-vitro electrode explant model to examine explant forces and intracochlear trauma across multiple electrode types and insertion depths. Study design An in-vitro model using gel to represent tissue surrounding the electrode was developed. Pre-curved electrodes and straight electrodes at different insertion depths (20mm, 25mm, 28mm) were explanted from the model. During explantation, explant force was measured, and high-definition videos were recorded to capture electrode exit path and gel disruption. Results Explant force patterns varied based on electrode position in the scala tympani. Explant forces did not correlate with gel disruption, which represented explant trauma. The least gel disruption occurred with pre-curved electrodes and the under-inserted straight electrode. The greatest disruption occurred with the overly inserted straight electrode. Conclusion An in-vitro model using gel to mimic tissue surrounding the electrode may provide insights into potential electrode explant trauma. Explant force did not correlate with explant trauma in our model. Pre-curved electrodes and shallower insertion depth of a straight electrode resulted in the least amount of explant trauma.

Objectives: The aim of this discussion paper and literature review was to estimate the incidence of a variety of complications associated with the surgical placement of cochlear implant (CI) electrode arrays and to discuss the implications and management of sub-optimal electrode placement. Results: A review of the peer-reviewed literature suggests that the incidence of incomplete electrode insertion and kinking is more prevalent in straight arrays and not more than about 2% in CI recipients with normal cochlear anatomy/patency. Incidence of tip fold-over is greater with perimodiolar arrays but also occurs with straight arrays and is typically less than 5%. Conversely, electrode migration is more common with straight arrays, and high rates (up to 46%) have been reported in some studies. Scalar translocations have also been reported for both perimodiolar and straight arrays. Higher rates have been reported for stylet-based perimodiolar electrodes inserted via cochleostomy (up to 56%), but with much lower rates (<10%) with both sheath-based perimodiolar arrays and lateral wall arrays. Electrode positioning complications represent a significant proportion of perioperative CI complications and compromise the level of benefit from the device. Careful surgical planning and appropriate pre- and intraoperative imaging can reduce the likelihood and impact of electrode positioning complications. There is also evidence that newer array designs are less prone to certain complications, particularly scalar translocation. Conclusions: It is important that implanting surgeons are aware of the impact of sub-optimal electrode placement and the steps that can be taken to avoid, identify and manage such complications.

OBJECTIVE:To compare the difference in electrode impedance across discrete time points to 24 months post-activation for two groups of adult cochlear implant recipients, one using an investigational perimodiolar (Contour Advance®) array augmented with 40% concentration weight per weight (w/w) dexamethasone (the Drug Eluting Electrode, 'DEE' Group), and the other the commercially available Contour Advance ('Control' Group).DESIGN:Ten adult subjects were implanted with the DEE and fourteen with the Control. Electrode impedances were measured intra-operatively, one-week post-surgery, at initial activation (approximately two-weeks post-surgery), and at approximately one, three, six, 12 and 24 months post-activation. Two different impedance measurements were obtained: 1) in MP1+2 mode using Custom Sound programming software; and 2) 4-point impedance measures utilising BP+2 stimulation mode with recording on non-stimulating electrodes. Data were analysed with respect to both impedance averaged across all electrodes, and impedance for electrodes grouped into basal, middle and apical sections.RESULTS:Group mean MP1+2 impedance for the DEE was significantly lower than for the Control at all post-operative time points examined, and for each of the basal, middle and apical cochlear regions. Group mean 4-point impedance was significantly lower for the DEE than the Control in the basal region at six, 12 and 24 months post-activation and in the middle region at 12- and 24-months post-activation. The pattern of change in MP1+2 impedance differed significantly in the early post-operative period prior to device activation. A significant 4.8 kOhm reduction in impedance between surgery and one-week was observed for the DEE group but not for the Control. A 2.0 kOhm increase between the one and two week post-operative time points was observed for the Control but not for the DEE group.CONCLUSION:While rates of adoption of different surgical approaches differed between the groups and this may have had a confounding effect, the results suggest that passive elution of dexamethasone from the investigational device was associated with a change in the intracochlear environment following surgical implantation of the electrode array, as evidenced by the lower electrode impedance measures.

Postoperative inflammation and the formation of fibrotic tissue around the intracochlear electrode array are often held responsible for negative outcomes in cochlear implant recipients. Here we test the effectiveness of intracochlear delivery of dexamethasone via a drug-eluting electrode array in reducing fibrotic tissue formation, assessed via measurement of both monopolar and four-point electrode impedance. Adult guinea pigs were bilaterally implanted with a dexamethasone-eluting array (left ear) and a standard non-eluting array (right ear). Arrays were electrically stimulated daily for 4 weeks, commencing 1 week after implantation, and impedance measured both before and after stimulation. Histological assessment of the tissue was made at the end of the 5-week period. The dexamethasone-eluting array did not reduce monopolar (MP1 + 2) electrode impedance over the course of 5 weeks, and no significant difference was observed in fibrotic tissue, new bone growth, or spiral ganglion neuron density between array types. However, four-point impedance, which provides an indication of the local environment at the neural-tissue interface, was significantly lower in the presence of dexamethasone. A strong relationship was seen between four-point and monopolar impedance for individual electrode arrays, with the exception of the standard array after daily electrical stimulation. This group instead showed a significant correlation between the final four-point impedance measure and percentage of fibrous tissue and new bone growth. In conclusion, this study demonstrated that dexamethasone influences four-point electrode impedance as well as the relationship between fibrotic tissue and impedance, and that both outcomes are shaped by daily electrical stimulation. These results suggest a change occurs at the local tissue-electrode interface in the presence of sustained, intracochlear release of dexamethasone.

To better understand the spread of prosthetic current in the inner ear and to facilitate design of electrode arrays and stimulation protocols for a vestibular implant system intended to restore sensation after loss of vestibular hair cell function, we created a model of the primate labyrinth. Because the geometry of the implanted ear is complex, accurately modeling effects of prosthetic stimuli on vestibular afferent activity required a detailed representation of labyrinthine anatomy. Model geometry was therefore generated from three-dimensional (3D) reconstructions of a normal rhesus temporal bone imaged using micro-MRI and micro-CT. For systematically varied combinations of active and return electrode location, the extracellular potential field during a biphasic current pulse was computed using finite element methods. Potential field values served as inputs to stochastic, nonlinear dynamic models for each of 2415 vestibular afferent axons, each with unique origin on the neuroepithelium and spiking dynamics based on a modified Smith and Goldberg model. We tested the model by comparing predicted and actual 3D vestibulo-ocular reflex (VOR) responses for eye rotation elicited by prosthetic stimuli. The model was individualized for each implanted animal by placing model electrodes in the standard labyrinth geometry based on CT localization of actual implanted electrodes. Eye rotation 3D axes were predicted from relative proportions of model axons excited within each of the three ampullary nerves, and predictions were compared to archival eye movement response data measured in three alert rhesus monkeys using 3D scleral coil oculography. Multiple empirically observed features emerged as properties of the model, including effects of changing active and return electrode position. The model predicts improved prosthesis performance when the reference electrode is in the labyrinth’s common crus (CC) rather than outside the temporal bone, especially if the reference electrode is inserted nearly to the junction of the CC with the vestibule. Extension of the model to human anatomy should facilitate optimal design of electrode arrays for clinical application.

The electrode array of a cochlear implant forms a permanent, often lifelong interface between the implanted electronics and neural structures of the cochlea. A cochlear implant is primarily prescribed to restore hearing via electrical stimulation of the auditory nerve. As with any neural stimulator intended to either deliver electrical stimulus or record a neural response, the aim is to place the electrodes in close proximity to the target neural structures. The broadening of indications and the concept of preservation of low-frequency residual hearing over the last two decades has resulted in an increased understanding of the mechanisms and implications of intracochlear trauma for both the hearing preservation surgery and electrical stimulation outcomes with cochlear implantation, as well as the influence of many biographic and audiological patient factors correlated with achieving better hearing outcomes. These two goals, the proximity to the cochlear nerve for electrical stimulation and the preservation of cochlear structures, have typically been viewed as mutually exclusive, with perimodiolar electrode arrays being preferred for the former, and lateral wall electrode arrays for the latter. The design evolution of both the lateral wall and perimodiolar electrodes is presented, considering the cochlea anatomy and continued understanding of the mechanics and dynamics of electrode insertion, along with the influence of the ongoing changes to the intracochlear environment to provide a rationale for the electrode design with the intent to provide the greatest patient benefit over their implanted lifetime.

OBJECTIVE:To compare the benefits of a dexamethasone-eluting array for hearing preservation and cochlear histopathology in low trauma (soft-surgery) and high trauma models of cochlear implant surgery.METHODS:Adult guinea pigs were implanted with an intra-cochlear array using two different surgical procedures: either a soft-surgery approach or following generation of electrode insertion trauma (high trauma). Two methods of dexamethasone delivery were evaluated: elution from an electrode array alone, and elution from a cochlear implant electrode array in combination with a pre-operative systemic injection. All electrode arrays were implanted for a period of 4 weeks. Outcome measures at 4 weeks post-implantation included auditory brainstem response (ABR) thresholds, histological analysis of spiral ganglion neuron density, fibrotic tissue, new bone growth, and cochlear damage.RESULTS:Animals exposed to high surgical trauma showed greater hearing loss than those in the low trauma model, irrespective of the presence of dexamethasone. Whilst the area of intra-cochlear fibrotic tissue growth post-implantation was also independent of dexamethasone administration, new bone growth was significantly reduced in its presence. Our high trauma model effectively obliterated the organ of Corti and significantly reduced spiral ganglion neuron densities in the lower basal turn. This trauma-induced reduction in spiral ganglion neuron survival decreased with the inclusion of a dexamethasone-eluting array. A pre-operative systemic injection of dexamethasone did not significantly improve any outcome measures beyond those provided with a dexamethasone-eluting array alone.CONCLUSION:Dexamethasone-eluting intra-cochlear arrays may inhibit osteoneogenesis, and reduce spiral ganglion neuron loss following traumatic cochlear implantation.

Hypothesis: To explore the results of a new slim modiolar electrode array (SMA) with respect to intracochlear placement and trauma evaluated by detailed radiologic imaging and histology. Background: Hearing and structure preservation is the goal of cochlear implantation for advanced hearing outcomes. Currently, this is most consistently achieved with thin lateral wall electrodes. Modiolar electrodes are located nearer the modiolus and may provide some electrophysiological advantages, but have a greater tendency for causing insertion trauma. Methods: The SMA was implanted in 20 fresh-frozen human temporal bones (TB). All TBs were scanned pre- and postoperatively with cone beam computed tomography. For atraumatic insertion, the round window approach was preferred. Scalar localization and trauma were analyzed by three-dimensional image fusion reconstructions of the pre- and postimplant scans. The TBs underwent histologic examination to validate the radiologic findings. Results: Insertion through the round window was performed in 19 TBs and through a cochleostomy in one TB. In one TB trauma in the form of scala translocation was identified radiologically and histologically. In the remaining TBs there was no insertion trauma. Adequate modiolar localization of the SMA was found in 19 of 20 TBs. The mean angular insertion depth was 400 degrees without correlation to cochlea size. There was no significant statistical difference between the radiological and histological measurements of electrode localization. Conclusion: The SMA showed consistent and atraumatic insertion results in TBs. Pre- and postimplant cone beam computed tomography with image fusion was shown to be very accurate for the assessment of electrode position and insertion trauma.

cal treatment and patients with middle ear disease and treated surgically within 2 months of presentation all showed some recovery in facial nerve function. In those with apical disease the palsy was often present for many years and facial nerve function did not improve but nor did it deteriorate post-operatively in these more long-standing cases. Facial nerve palsy associated with cholesteatoma should be treated surgically as early as possible but recovery can still be anticipated, even if treatment is delayed for up to 2 months.

Hypothesis: Scala tympani morphology influences the insertion dynamics and intra-scalar position of straight electrode arrays.Background: Hearing preservation is the goal of cochlear implantation with current thin straight electrode arrays. These hug the lateral wall, facilitating full, atraumatic insertions. However, most studies still report some postoperative hearing loss. This study explores the influence of scala tympani morphology on array position relative to the basilar membrane and its possible contribution to postoperative hearing loss.Materials and Methods: Twenty-six fresh-frozen human temporal bones implanted with a straight electrode array were three-dimensionally reconstructed from micro-photographic histological sections. Insertion depth and the proximity between the array and basilar membrane were recorded. Lateral wall shape was quantified as a curvature ratio.Results: Insertion depths ranged from 233 to 470 degrees. The mean first point of contact between the array and basilar membrane was 185 degrees; arrays tended to remain in contact with the membrane after first contacting it. Eighty-nine and 93% of arrays that reached the upper basal (>240-360 degrees) and second (>360-720 degrees) turns respectively contacted the basilar membrane in these regions. Scalar wall curvature ratio decreased significantly (the wall became steeper) from the basal to second turns. This shift correlated with a reduced distance between the array and basilar membrane.Conclusion: Scala tympani morphology influences the insertion dynamics and intra-scalar position of a straight electrode array. In addition to gross trauma of cochlear structures, contact between the array and basilar membrane and how this impacts membrane function should be considered in hearing preservation cases.

Objective: This study assessed the prevalence of electrode failures and electrode impedance measures in Nucleus cochlear implants around initial activation (an average of 16 days after surgery) and after 8 to 12 years of device use. Design: Retrospective data from the Melbourne Cochlear Implant Clinic was collated and analysed. Study sample: Included in this study were 232 adults, all of whom were implanted at the clinic between March 1998 and August 2005. Results: Overall 0.5% of electrodes failed over the entire test period, with 5.6% of devices showing one or more electrode failure. The majority of these failures were recorded by initial activation. The numbers of electrode failures have decreased over time with array type, such that no failures were recorded with the currently available Contour Advance array. Array type was shown to affect electrode impedance at both time points, with the Contour and Contour Advance arrays having significantly higher absolute values than the Banded array. However, the Banded array had significantly higher area-normalized impedances at initial and final measures than the Contour and Contour Advance array. Conclusions: A relatively low incidence of electrode failures were recorded for the Nucleus devices of these recipients. Electrode impedance dropped for all array types after 8 to 12 years of device use.

OBJECTIVE:To assess the utility of cone-beam computed tomography (CBCT) imaging in the estimation of cochlear implant (CI) electrode position in implanted temporal bones. STUDY DESIGN:Eight fresh frozen temporal bones were mounted and oriented as for standard surgery and were implanted with Cochlear Slim-Straight (SS) or Contour Advance electrode arrays by 2 CI surgeons. The bones were then imaged using an Accuitomo F170 CBCT scanner (isometric 250 μm voxel size) and were then processed for histologic sectioning (500 μm sections). MAIN OUTCOME MEASURES:The CBCT images and the histologic micrographs (providing the "gold standard") were examined independently by several observers who assessed the scalar position (tympani or vestibuli) of each electrode in each temporal bone specimen. RESULTS:Examination of the histologic micrographs confirmed that all electrodes were positioned within the scala tympani in all 8 bones. Similar judgments were made by the observers rating the CBCT images, except that one of the 2 observers estimated some of the apical electrodes to be located in the scala vestibuli in two of the bones implanted with the SS electrode. CONCLUSION:Cone-beam CT imaging is able to provide a good indication of the scalar position of implanted electrodes, although estimation may be slightly less reliable for apical electrodes and for straight electrode designs. Additional advantages of using CBCT for this purpose are shorter acquisition time and reduction of radiation dose as compared with conventional CT.

OBJECTIVES:Cochlear implantation can result in trauma leading to increased tissue response and loss of residual hearing. A single intratympanic application of the corticosteroid dexamethasone is sometimes used clinically during surgery to combat the potential effect of trauma on residual hearing. This project looked at the safety and efficacy of dexamethasone eluted from an intracochlear array in vivo.METHODS:Three trials were conducted using normal hearing adult guinea pigs implanted with successive iterations of dexamethasone-eluting (DX1, DX2, and DX3) or non-eluting (control) intracochlear electrode arrays. The experimental period for each animal was 90 days during which hearing tests were performed at multiple time points.RESULTS:There was no significant difference between matched control array and dexamethasone array groups in terms of spiral ganglion neuron density, organ of Corti condition, or fibrosis and ossification. A cochleostomy seal was present in all implanted cochleae. There were no differences in the degree of hearing threshold shifts between DX1 and DX3 and their respective control arrays. Cochleae implanted with DX2 arrays showed less hearing loss and marginally better spiral ganglion neuron survival than their control array counterparts. Post-explant inspection of the DX2 and DX3 arrays revealed a difference in pore density following dexamethasone elution.CONCLUSION:The dexamethasone doses used were safe in the guinea pig cochlea. Dexamethasone did not inhibit formation of a cochleostomy seal. The level of hearing protection afforded by dexamethasone eluting from an intracochlear array may depend upon the degree of elution and level of trauma inflicted.

Postoperative imaging plays a growing role in clinical studies concerning prognostic factors in cochlear implantation. Indeed, intracochlear position of the cochlear implant has recently been identified as a contributor in functional outcomes and radiological tools must be accurate enough to determine the final placement of the electrode array. The aim of our study was to validate cone beam computed tomography as a reliable technique for scalar localization of the electrode array. We performed therefore a temporal bone study on ten specimens that were implanted with a perimodiolar implant prototype. Cone beam reconstructions were performed and images were analyzed by two physicians both experienced in cochlear implant imaging, who determined the scalar localization of the implant. Temporal bones then underwent histological control to document this scalar localization and hypothetical intracochlear lesions. In four cases, a dislocation from scala tympani to scala vestibuli was suspected on cone beam reconstructions of the ascending part of the basal turn. In three of these four specimens, dislocation in pars ascendens was confirmed histologically. In the remaining temporal bone, histological analysis revealed an elevation with rupture of the basilar membrane. Histological assessment revealed spiral ligament tearing in another bone. We conclude that cone beam is a reliable tool to assess scalar localization of the selectrode array and may be used in future clinical studies.

Hypothesis It is possible to implant a stimulating electrode array in the semicircular canals without damaging rotational sensitivity or hearing. The electrodes will evoke robust and precisely controlled eye movements. Background A number of groups are attempting to develop a neural prosthesis to ameliorate abnormal vestibular function. Animal studies demonstrate that electrodes near the canal ampullae can produce electrically evoked eye movements. The target condition of these studies is typically bilateral vestibular hypofunction. Such a device could potentially be more widely useful clinically and would have a simpler roadmap to regulatory approval if it produced minimal or no damage to the native vestibular and auditory systems. Methods An electrode array was designed for insertion into the bony semicircular canal adjacent to the membranous canal. It was designed to be sufficiently narrow so as to not compress the membranous canal. The arrays were manufactured by Cochlear, Ltd., and linked to a Nucleus Freedom receiver/stimulator. Seven behaviorally trained rhesus macaques had arrays placed in 2 semicircular canals using a transmastoid approach and “soft surgical” procedures borrowed from Hybrid cochlear implant surgery. Postoperative vestibulo-ocular reflex was measured in a rotary chair. Click-evoked auditory brainstem responses were also measured in the 7 animals using the contralateral ear as a control. Results All animals had minimal postoperative vestibular signs and were eating within hours of surgery. Of 6 animals tested, all had normal postoperative sinusoidal gain. Of 7 animals, 6 had symmetric postoperative velocity step responses toward and away from the implanted ear. The 1 animal with significantly asymmetric velocity step responses also had a significant sensorineural hearing loss. One control animal that underwent canal plugging had substantial loss of the velocity step response toward the canal-plugged ear. In 5 animals, intraoperative electrically evoked vestibular compound action potential recordings facilitated electrode placement. Postoperatively, electrically evoked eye movements were obtained from electrodes associated with an electrically evoked vestibular compound action potential wave form. Hearing was largely preserved in 6 animals and lost in 1 animal. Conclusion It is possible to implant the vestibular system with prosthetic stimulating electrodes without loss of rotational sensitivity or hearing. Because electrically evoked eye movements can be reliably obtained with the assistance of intraoperative electrophysiology, it is appropriate to consider treatment of a variety of vestibular disorders using prosthetic electrical stimulation. Based on these findings, and others, a feasibility study for the treatment of human subjects with disabling Ménière’s disease has begun.

OBJECTIVE:Multi-centre collaborative study to develop and refine the design of a prototype thin perimodiolar cochlear implant electrode array and to assess feasibility for use in human subjects.STUDY DESIGN:Multi-centre temporal bone insertion studies.MATERIALS AND METHODS:The modiolar research array (MRA) is a thin pre-curved electrode that is held straight for initial insertion with an external sheath rather than an internal stylet. Between November 2006 and February 2009, six iterations of electrode design were studied in 21 separate insertion studies in which 140 electrode insertions were performed in 85 human temporal bones by 12 surgeons. These studies aimed at addressing four fundamental questions related to the electrode concept, being: (1) Could a sheath result in additional intra-cochlear trauma? (2) Could a sheath accommodate variations in cochlea size and anatomies? (3) Could a sheath be inserted via the round window? and (4) Could a sheath be safely removed once the electrode had been inserted? These questions were investigated within these studies using a number of evaluation techniques, including X-ray and microfluoroscopy, acrylic fixation and temporal bone histologic sectioning, temporal bone microdissection of cochlear structures with electrode visualization, rotational tomography, and insertion force analysis.RESULTS:Frequent examples of electrode rotation and tip fold-over were demonstrated with the initial designs. This was typically caused by excessive curvature of the electrode tip, and also difficulty in handling of the electrode and sheath. The degree of tip curvature was progressively relaxed in subsequent versions with a corresponding reduction in the frequency of tip fold-over. Modifications to the sheath facilitated electrode insertion and sheath removal. Insertion studies with the final MRA design demonstrated minimal trauma, excellent perimodiolar placement, and very small electrode dimensions within scala tympani. Force measurements in temporal bones demonstrated negligible force on cochlear structures with angular insertion depths of between 390 and 450°.CONCLUSION:The MRA is a novel, very thin perimodiolar prototype electrode array that has been developed using a systematic collaborative approach. The different evaluation techniques employed by the investigators contributed to the early identification of issues and generation of solutions. Regarding the four fundamental questions related to the electrode concept, the studies demonstrated that (1) the sheath did not result in additional intra-cochlear trauma; (2) the sheath could accommodate variations in cochlea size and anatomies; (3) the sheath was more successfully inserted via a cochleostomy than via the round window; and (4) the sheath could be safely removed once the electrode had been inserted.