Cochlear implant electrode design for safe and effective treatment.

The optimal placement of a cochlear implant (CI) electrode inside the scala tympani compartment to create an effective electrode-neural interface is the base for a successful CI treatment. The characteristics of an effective electrode design include (a) electrode matching every possible variation in the inner ear size, shape, and anatomy, (b) electrically covering most of the neuronal elements, and (c) preserving intra-cochlear structures, even in non-hearing preservation surgeries. Flexible electrode arrays of various lengths are required to reach an angular insertion depth of 680° to which neuronal cell bodies are angularly distributed and to minimize the rate of electrode scalar deviation. At the time of writing this article, the current scientific evidence indicates that straight lateral wall electrode outperforms perimodiolar electrode by preventing electrode tip fold-over and scalar deviation. Most of the available literature on electrode insertion depth and hearing outcomes supports the practice of physically placing an electrode to cover both the basal and middle turns of the cochlea. This is only achievable with longer straight lateral wall electrodes as single-sized and pre-shaped perimodiolar electrodes have limitations in reaching beyond the basal turn of the cochlea and in offering consistent modiolar hugging placement in every cochlea. For malformed inner ear anatomies that lack a central modiolar trunk, the perimodiolar electrode is not an effective electrode choice. Most of the literature has failed to demonstrate superiority in hearing outcomes when comparing perimodiolar electrodes with straight lateral wall electrodes from single CI manufacturers. In summary, flexible and straight lateral wall electrode type is reported to be gentle to intra-cochlear structures and has the potential to electrically stimulate most of the neuronal elements, which are necessary in bringing full benefit of the CI device to recipients.

Cochlear Implantation With a Dexamethasone Eluting Electrode Array: Functional and Anatomical Changes in Non-Human Primates.

OBJECTIVES: The aim of this study was to determine whether the dexamethasone-eluting electrode (DEXEL) has a protective anti-inflammatory effect in a normal hearing implanted cochlea, as well as its performance and safety. DESIGN: Ten healthy and normal hearing cynomolgus macaques (Mf) were divided into two cohorts: DEXEL group (DG) (CONCERTO CI device containing a DEXEL) and conventional CI group (CG) (unmodified CONCERTO CI device). The electrode was inserted into the scala tympani via the round window with an angle of insertion of 270 degrees. Auditory, impedance, electrically evoked compound action potential (eCAP), and recovery of function measurements were recorded monthly until sacrifice at 6 months post-implantation. A histologic analysis was also performed. RESULTS: At 6 months, measurement of auditory brainstem responses revealed a mean threshold shift, as well as a mean impedance value, lower in the DEXEL group. The minimum eCAP for the remaining active contacts in the DEXEL group was 68% of that in the conventional CI group. Also at 6 months, the eCAP amplitude produced by a stimulating current of 800 cu (eCAP) was almost 2.5-fold higher in the DEXEL group than in the conventional CI group (1338.86 ±â€Š637.87 µV versus 545.00 ±â€Š137.37 µV; p = 0.049). Tissue reactions, in particular fibrosis and ossification, were more common in the conventional CI group. CONCLUSIONS: The CI electrode array equipped with a dexamethasone-eluting component tested in macaques evidence that delivery of dexamethasone to the inner ear may produce rapid and long-lasting improvement of hearing with fewer neural tissue reactions.

Literature Review on the Distribution of Spiral Ganglion Cell Bodies inside the Human Cochlear Central Modiolar Trunk.

This study aims to obtain a better understanding of the number and distribution of spiral ganglion cell bodies (SGCBs) in the central modiolar trunk of the human cochlea with normal hearing as well as with hearing loss due to various pathological conditions. A detailed PubMed search was performed using the key words "human spiral ganglion cell population," "analysis of spiral ganglion cell population," "survival of human spiral ganglion cells," "human Rosenthal's canal," "human ganglion cell counts," and "distribution of human spiral ganglion cells" to identify articles published between 1931 and 2019. The articles were included if the number of SGCBs in the four segments of the human cochlea and angular depth distribution of the SGCBs were mentioned. Out of the 237 articles that were initially identified, 20 articles met the inclusion criteria. The presence of SGCBs inside the Rosenthal's canal (RC) in the modiolar trunk extended to an angular depth of 630°-680°, which is close to the end of the second turn of the cochlea. SGCBs in Segment-IV of the cochlea account for approximately 25-30% of the entire SGCB population, regardless of the cochlear condition (normal vs. pathologic). In normal-hearing subjects, the total number of SGCB cases ranged between 23,910 and 33,702; in patients with hearing loss, the same was between 5,733 and 28,220. This literature review elaborates on the current state of knowledge regarding the number and distribution of SGCBs in the human cochlea.

Review on cochlear implant electrode array tip fold-over and scalar deviation.

OBJECTIVE: Determine the occurrence rate of cochlear implant (CI) electrode tip fold-over and electrode scalar deviation as reported in patient cases with different commercial electrode types. DATA-SOURCES: PubMed search for identifying peer-reviewed articles published till 2018 on CI electrode tip fold-over and scalar deviation. Key-words for searching were "Cochlear electrode tip fold-over", "Cochlear electrode scalar position" and "Cochlear electrode scalar location". ARTICLES-SELECTION: Only if electrode related issues were investigated in patient cases. 38 articles met the inclusion-criteria. RESULTS: 13 articles on electrode tip fold-over issue covering 3177 implanted ears, out of which 50 ears were identified with electrode tip fold-over with an occurrence rate of 1.57%. Out of 50 ears, 43 were implanted with pre-curved electrodes and the remaining 7 with lateral-wall electrodes. One article reported on both tip fold-over and scalar deviation. 26 articles reported on the electrode scalar deviation covering an overall number of 2046 ears out of which, 458 were identified with electrode scalar deviation at a rate of 22.38%. After removing the studies that did not report on the number of electrodes per electrode type, it was 1324 ears implanted with pre-curved electrode and 507 ears with lateral-wall electrode. Out of 1324 pre-curved electrode implanted ears, 424 were reported with scalar deviation making an occurrence rate of 32%. Out of 507 lateral-wall electrode implanted ears, 43 were associated with scalar deviation at an occurrence rate of 6.7%. CONCLUSION: This literature review revealing the fact of higher rate of electrode insertion trauma associated with pre-curved electrode type irrespective of CI brand is one step closer to obsolete it from the clinical practice in the interest of patient's cochlear health.

Human Inner-ear Malformation Types Captured in 3D.

OBJECTIVES: Capture the human inner-ear malformation types in 3D by segmenting the inner-ear structures from clinical CT (computed tomography) and MR (magnetic resonance) image datasets. Volumetric analysis was done to find the variations in the volume of cochlear part alone from complete inner-ear followed by 3D printing from the 3D segmented models. MATERIALS AND METHODS: Using 3D slicer freeware, the complete inner-ear structures were segmented from anonymized CT and MR image by setting a tight grey-scale threshold to avoid capturing unwanted structures followed by volumetric analysis of the cochlear part alone. 3D printing was done using Form labs desktop 3D printer. RESULTS: We identified 2x normal anatomy (NA) cochlea, 1x enlarged vestibular aqueduct syndrome (EVAS), 3x incomplete partition (IP) type-I, 4x IP type-II, 3x IP type-III, 5x common cavity (CC) and 5x cochlear hypoplasia (CH). 3D segmented models along with the 3D printed models showed huge variation in size, shape and the anatomy among the image data-sets analyzed. Volumetric analysis showed that on average, volume of CC was above 150mm3, volume of CH fell below 80mm3, Volume of NA, EVAS and IP-I were all around 85-105mm3 whereas the volume of IP-II was around 50mm3. CONCLUSION: Visualizing human inner-ear malformation types in 3D both as computer models and as 3D printed models is a whole-new experience as demonstrated in this study. The volumetric analysis showed a huge variation among the volume of cochlear part alone among the malformation types.

A Novel Method for Clinical Cochlear Duct Length Estimation toward Patient-Specific Cochlear Implant Selection.

OBJECTIVE: In the field of cochlear implantation, the current trend toward patient-specific electrode selection and the achievement of optimal audiologic outcomes has resulted in implant manufacturers developing a large portfolio of electrodes. The aim of this study was to bridge the gap between the known variability of cochlea length and this electrode portfolio. DESIGN: Retrospective analysis on cochlear length and shape in micro-computed tomography and cone beam computed tomography data. SETTING: Tertiary care medical center. SUBJECTS AND METHODS: A simple 2-step approach was developed to accurately estimate the individual cochlear length as well as the projected length of an electrode array inside the cochlea. The method is capable of predicting the length of the cochlea and the inserted electrode length at any specific angle. Validation of the approach was performed with 20 scans of human temporal bones (micro-computed tomography) and 47 pre- and postoperative clinical scans (cone beam computed tomography). RESULTS: Mean ± SD absolute errors in cochlear length estimations were 0.12 ± 0.10 mm, 0.38 ± 0.26 mm, and 0.71 ± 0.43 mm for 1, 1.5, and 2 cochlea turns, respectively. Predicted insertion angles based on clinical cone beam computed tomography data showed absolute deviations of 27° ± 18° to the corresponding postoperative measurements. CONCLUSION: With accuracy improvements of 80% to 90% in comparison with previously proposed approaches, the method is well suited for the use in individualized cochlear implantation.

An overview of cochlear implant electrode array designs.

Cochlear implant electrode arrays are designed with specific characteristics that allow for the preservation of intra-cochlear structures during the insertion process, as well as during explantation. Straight lateral wall (LW) electrode arrays and pre-curved modiolar hugging (MH) electrode arrays are the two types that are commercially available. Although there is a third type of electrode array called the mid-scala (MS), which is positioned in the middle of the scala tympani (ST), and is usually considered as an MH type of electrode. Different lengths of straight LW electrode arrays are currently available which allow for insertion across a range of different sized cochleae; however, due to manufacturing limitations, pre-curved MH electrodes are generally only available to cover the basal turn of the cochlea, while the spiral ganglion cells are distributed in the Rosenthal's canal that extends into 1.75 turns of the cochlea. Both straight LW and pre-curved MH electrodes can cause a certain degree of intra-cochlear trauma, but pre-curved MH electrodes tend to deviate into the scala vestibuli from the scala tympani more often than the straight LW electrodes, resulting in damage to the osseous spiral lamina/spiral ligament which could initiate new bone formation and eventually affect the cochlear implant users' hearing performance. Structural damage to the cochlea could also affect the vestibular function. With pre-curved MH electrodes, higher degrees of trauma are related to the fixed curling geometry of the electrode in relation to the variable coiling pattern of individual cochleae, the orientation of the electrode contacts in relation to the modiolus wall, and how effectively the stylet was handled by the surgeon during the procedure. Wire management, metal density, and the shore hardness of the silicone elastomer all contribute to the stiffness/flexibility of the electrode. It is important to acknowledge the impact of bringing the stimulating contacts closer to the modiolus wall with an MH electrode type in terms of the resultant damage to intra-cochlear structures. The presence of malformed cochleae should be identified and appropriate electrodes should be chosen for each specific cochlea, irrespective of the cochlear implant brand. In order to utilize drug therapy, the cochlea should be free from any trauma.

Local inner ear application of dexamethasone in cochlear implant models is safe for auditory neurons and increases the neuroprotective effect of chronic electrical stimulation.

Dexamethasone (DEX) can reduce fibrous tissue growth as well as loss of residual hearing which may occur after cochlear implantation. Little is known about the effect of local inner ear DEX treatment on the spiral ganglion neurons (SGN), which are the target of the electrical stimulation with a cochlear implant (CI). Three different clinically relevant strategies of DEX-delivery into the inner ear were used. DEX was either eluted from the electrode carriers' silicone, released from a reservoir by passive diffusion, or actively applied using a pump based system. The effect of the locally applied DEX on SGN density, size and function was evaluated. DEX did not affect the SGN density compared to the relevant control groups. Simultaneously applied with chronic electrical stimulation (ES), DEX increased the neuroprotective effect of ES in the basal region and the hearing threshold tended to decrease. The EABR thresholds did not correlate with the relevant SGN density. When correlating the SGN number with fibrosis, no dependency was observed. DEX concentrations as applied in these animal models are safe for inner ear delivery in terms of their effect on SGN density. Additionally, DEX tends to improve the neuroprotective effect of chronic electrical stimulation by increasing the number of surviving neurons. This is an important finding in regard to clinical applications of DEX for local treatment of the inner ear in view of cochlear implantation and other applications.

NANOCI-Nanotechnology Based Cochlear Implant With Gapless Interface to Auditory Neurons.

: Cochlear implants (CI) restore functional hearing in the majority of deaf patients. Despite the tremendous success of these devices, some limitations remain. The bottleneck for optimal electrical stimulation with CI is caused by the anatomical gap between the electrode array and the auditory neurons in the inner ear. As a consequence, current devices are limited through 1) low frequency resolution, hence sub-optimal sound quality and 2), large stimulation currents, hence high energy consumption (responsible for significant battery costs and for impeding the development of fully implantable systems). A recently completed, multinational and interdisciplinary project called NANOCI aimed at overcoming current limitations by creating a gapless interface between auditory nerve fibers and the cochlear implant electrode array. This ambitious goal was achieved in vivo by neurotrophin-induced attraction of neurites through an intracochlear gel-nanomatrix onto a modified nanoCI electrode array located in the scala tympani of deafened guinea pigs. Functionally, the gapless interface led to lower stimulation thresholds and a larger dynamic range in vivo, and to reduced stimulation energy requirement (up to fivefold) in an in vitro model using auditory neurons cultured on multi-electrode arrays. In conclusion, the NANOCI project yielded proof of concept that a gapless interface between auditory neurons and cochlear implant electrode arrays is feasible. These findings may be of relevance for the development of future CI systems with better sound quality and performance and lower energy consumption. The present overview/review paper summarizes the NANOCI project history and highlights achievements of the individual work packages.

Challenging aspects of contemporary cochlear implant electrode array design.

OBJECTIVE: A design comparison of current perimodiolar and lateral wall electrode arrays of the cochlear implant (CI) is provided. The focus is on functional features such as acoustic frequency coverage and tonotopic mapping, battery consumption and dynamic range. A traumacity of their insertion is also evaluated. METHODS: Review of up-to-date literature. RESULTS: Perimodiolar electrode arrays are positioned in the basal turn of the cochlea near the modiolus. They are designed to initiate the action potential in the proximity to the neural soma located in spiral ganglion. On the other hand, lateral wall electrode arrays can be inserted deeper inside the cochlea, as they are located along the lateral wall and such insertion trajectory is less traumatic. This class of arrays targets primarily surviving neural peripheral processes. Due to their larger insertion depth, lateral wall arrays can deliver lower acoustic frequencies in manner better corresponding to cochlear tonotopicity. In fact, spiral ganglion sections containing auditory nerve fibres tuned to low acoustic frequencies are located deeper than 1 and half turn inside the cochlea. For this reason, a significant frequency mismatch might be occurring for apical electrodes in perimodiolar arrays, detrimental to speech perception. Tonal languages such as Mandarin might be therefore better treated with lateral wall arrays. On the other hand, closer proximity to target tissue results in lower psychophysical threshold levels for perimodiolar arrays. However, the maximal comfort level is also lower, paradoxically resulting in narrower dynamic range than that of lateral wall arrays. Battery consumption is comparable for both types of arrays. CONCLUSIONS: Lateral wall arrays are less likely to cause trauma to cochlear structures. As the current trend in cochlear implantation is the maximal protection of residual acoustic hearing, the lateral wall arrays seem more suitable for hearing preservation CI surgeries. Future development could focus on combining the advantages of both types: perimodiolar location in the basal turn extended to lateral wall location for higher turn locations.

Impedance Changes and Fibrous Tissue Growth after Cochlear Implantation Are Correlated and Can Be Reduced Using a Dexamethasone Eluting Electrode.

BACKGROUND: The efficiency of cochlear implants (CIs) is affected by postoperative connective tissue growth around the electrode array. This tissue formation is thought to be the cause behind post-operative increases in impedance. Dexamethasone (DEX) eluting CIs may reduce fibrous tissue growth around the electrode array subsequently moderating elevations in impedance of the electrode contacts. METHODS: For this study, DEX was incorporated into the silicone of the CI electrode arrays at 1% and 10% (w/w) concentration. Electrodes prepared by the same process but without dexamethasone served as controls. All electrodes were implanted into guinea pig cochleae though the round window membrane approach. Potential additive or synergistic effects of electrical stimulation (60 minutes) were investigated by measuring impedances before and after stimulation (days 0, 7, 28, 56 and 91). Acoustically evoked auditory brainstem responses were recorded before and after CI insertion as well as on experimental days 7, 28, 56, and 91. Additionally, histology performed on epoxy embedded samples enabled measurement of the area of scala tympani occupied with fibrous tissue. RESULTS: In all experimental groups, the highest levels of fibrous tissue were detected in the basal region of the cochlea in vicinity to the round window niche. Both DEX concentrations, 10% and 1% (w/w), significantly reduced fibrosis around the electrode array of the CI. Following 3 months of implantation impedance levels in both DEX-eluting groups were significantly lower compared to the control group, the 10% group producing a greater effect. The same effects were observed before and after electrical stimulation. CONCLUSION: To our knowledge, this is the first study to demonstrate a correlation between the extent of new tissue growth around the electrode and impedance changes after cochlear implantation. We conclude that DEX-eluting CIs are a means to reduce this tissue reaction and improve the functional benefits of the implant by attenuating electrode impedance.

In vitro and in vivo pharmacokinetic study of a dexamethasone-releasing silicone for cochlear implants.

Cochlear implants have been widely used for patients with profound hearing loss and partial deafness. Residual low-frequency hearing, however, may deteriorate due to insertion trauma and tissue response around the electrode array. The present study investigated in vitro and in vivo release of dexamethasone from silicone used for cochlear implant electrode carriers. The in vitro experiment involved an apparatus simulating the inner ear fluid environment in humans. Release from two sizes of silicone films (200 µm × 1 mm × 10 mm and 500 µm × 1 mm × 10 mm), each loaded with 2 % dexamethasone, and was measured for 24 weeks. In the in vivo experiment, silicone rods loaded with 2 or 10 % dexamethasone, respectively, were implanted into the scala tympani of guinea pigs. Perilymph concentrations were measured during the first week after implantation. The results showed that dexamethasone was released from the silicone in a sustained manner. After a burst release, perilymph concentration was similar for silicone incorporated with 2 and 10 % dexamethasone, respectively. The similar pharmacokinetic profile was found in the in vitro experiment. The period of sustained drug delivery was maintained for 20 weeks in vitro and for 1 week in vivo. The results of the present study suggest that drugs like dexamethasone are released in a controlled manner from silicon electrode carriers of cochlear implants. Further studies will identify optimal release profiles for the use with cochlear implants to improve their safety and long-term performance.

Cesarean analgesia using levobupivacaine continuous wound infiltration: a randomized trial.

OBJECTIVE: Neuraxial morphine is considered as a "gold standard" for pain relief after cesarean section, however it causes bothersome side effects. Alternative analgesia including nonsteroidal antiinflammatory drugs (NSAID) has been proposed. We aimed to assess the morphine sparing effect of continuous wound infiltration with a local anesthetic, when added to multimodal systemic analgesia including NSAID without subarachnoid morphine. STUDY DESIGN: Sixty-eight women scheduled for elective cesarean section under spinal anesthesia were included in a randomized controlled open-label trial. Patients received bupivacaine spinal anesthesia without intrathecal morphine. Postoperative analgesia consisted for all patients in multimodal systemic analgesia with acetaminophen, nefopam, celecoxib, and patient-controlled intravenous morphine for 24h. The intervention group also received subfascial levobupivacaine infiltration through a multi-holed catheter, at 6.25mg/h for 48h. The primary endpoint was total morphine consumption at 24h postoperatively; and secondary endpoints were pain scores, side effects, breastfeeding comfort, maternal satisfaction, and nurse workload. Student t test, Mann-Whitney test or χ(2) test were used when appropriate. RESULTS: The intervention group had 6.7mg less morphine consumption (95%CI -1.3mg; -12mg, P=0.02), and 0.8 pain point less at rest on the numerical rating scale 0-10 (95%CI -0.3; -1.3, P=0.002). The intervention was associated with significantly better breastfeeding comfort (+1.7 at numerical rating scale score 0-10, 95%CI +0; +3.3, P=0.0498). Wound dressing changes were required in a significantly higher proportion of intervention-group women (12/34 vs. 1/34, P=0.002). CONCLUSION: Adding continuous levobupivacaine infiltration to multimodal analgesia after cesarean section without subarachnoid morphine decreased postoperative morphine consumption and pain, facilitated breastfeeding initial comfort, and slightly increased nurse workload.

Cochlear Dummy Electrodes for Insertion Training and Research Purposes: Fabrication, Mechanical Characterization, and Experimental Validation.

To develop skills sufficient for hearing preservation cochlear implant surgery, surgeons need to perform several electrode insertion trials in ex vivo temporal bones, thereby consuming relatively expensive electrode carriers. The objectives of this study were to evaluate the insertion characteristics of cochlear electrodes in a plastic scala tympani model and to fabricate radio opaque polymer filament dummy electrodes of equivalent mechanical properties. In addition, this study should aid the design and development of new cochlear electrodes. Automated insertion force measurement is a new technique to reproducibly analyze and evaluate the insertion dynamics and mechanical characteristics of an electrode. Mechanical properties of MED-EL's FLEX(28), FLEX(24), and FLEX(20) electrodes were assessed with the help of an automated insertion tool. Statistical analysis of the overall mechanical behavior of the electrodes and factors influencing the insertion force are discussed. Radio opaque dummy electrodes of comparable characteristics were fabricated based on insertion force measurements. The platinum-iridium wires were replaced by polymer filament to provide sufficient stiffness to the electrodes and to eradicate the metallic artifacts in X-ray and computed tomography (CT) images. These low-cost dummy electrodes are cheap alternatives for surgical training and for in vitro, ex vivo, and in vivo research purposes.

Effects of a dexamethasone-releasing implant on cochleae: A functional, morphological and pharmacokinetic study.

AIM: This study evaluated the impact of a dexamethasone-releasing silicone implant on hearing function preservation, cochlear morphology and perilymph pharmacokinetics after cochlear implantation. METHODS: Guinea pigs were implanted unilaterally with silicone rods containing either 2% dexamethasone (DEXA group, n = 18) or no dexamethasone (control group, n = 17). Auditory brainstem response (ABR) and distortion product otoacoustic emissions (DPOAEs) were measured preoperatively and over 6 months postoperatively. Cochlear histology using standard hematoxylin and eosin (H&E) staining and tumor necrosis factor (TNF)-alpha staining was performed 1 month postoperatively. Twenty-two guinea pigs were involved in the pharmacokinetic study, and real-time drug concentrations in perilymph were investigated using high-performance liquid chromatography (HPLC). The Mann-Whitney U test (1-tailed) was used for statistical analyses. RESULTS: ABR and DPOAE testing demonstrated decreased hearing function immediately postoperatively followed by a progressive hearing loss within the first day postoperatively. There was almost no observable hearing improvement in the control group from 1 week to 6 months postoperatively, but hearing levels in the DEXA group improved gradually from 1 week to 12 weeks. Hearing loss in the DEXA and control group was 5.0 ± 3.4 dB and 21.7 ± 5.3 dB, respectively at a 16-kHz stimulus frequency 6 months postoperatively. The difference in threshold shifts was present throughout all measured frequencies, and it was significant at 4-24 kHz. The morphological study revealed new fibrosis formation in the scala tympani, which encapsulated the implanted electrode. TNF-alpha positive staining in the cochleae of the DEXA group was less evident than the control group. The pharmacokinetic study revealed a peak perilymph concentration 30 min postoperatively and sustained dexamethasone release at least 1 week postoperatively. CONCLUSION: Cochlear implants that incorporate dexamethasone can release drug chronically in the inner ear and induce significant long-term recovery and preservation of auditory function after implantation.

Imaging cochlear implantation with round window insertion in human temporal bones and cochlear morphological variation using high-resolution cone beam CT.

CONCLUSIONS: The present experimental set-up of high spatial resolution cone-beam computed tomography (CBCT) showed advantages of demonstrating the critical landmarks of the cochlea in identifying the position of intracochlear electrode contacts and has the potential for clinical application in cochlear implant (CI) surgery. OBJECTIVE: To evaluate a newly developed CBCT system in defining CI electrode array in human temporal bone and cochlear morphological variation. METHODS: Standard electrode, flexible tip electrode (Flex28), and an experimental electrode array with 36 contacts from MED-EL were implanted into the cochleae of six human temporal bones through an atraumatic round window membrane insertion. The cochleae were imaged with 900 frames using an experimental set-up based on a CBCT scanner installed with Superior SXR 130-15-0.5 X-ray tube in combination with filtration of copper and aluminum. RESULTS: In all temporal bones, the landmarks of the cochlea, modiolus, osseous spiral lamina, round window niche, and stapes were demonstrated at an average level of 3.4-4.5. The contacts of electrode arrays were clearly shown to locate in the scala tympani. There was a linear correlation between the 'A' value and cochlea height, and between the A value and actual electrode insertion length for the first 360° insertion depth.

Deep electrode insertion and sound coding in cochlear implants.

Present-day cochlear implants demonstrate remarkable speech understanding performance despite the use of non-optimized coding strategies concerning the transmission of tonal information. Most systems rely on place pitch information despite possibly large deviations from correct tonotopic placement of stimulation sites. Low frequency information is limited as well because of the constant pulse rate stimulation generally used and, being even more restrictive, of the limited insertion depth of the electrodes. This results in a compromised perception of music and tonal languages. Newly available flexible long straight electrodes permit deep insertion reaching the apical region with little or no insertion trauma. This article discusses the potential benefits of deep insertion which are obtained using pitch-locked temporal stimulation patterns. Besides the access to low frequency information, further advantages of deeply inserted long electrodes are the possibility to better approximate the correct tonotopic location of contacts, the coverage of a wider range of cochlear locations, and the somewhat reduced channel interaction due to the wider contact separation for a given number of channels. A newly developed set of strategies has been shown to improve speech understanding in noise and to enhance sound quality by providing a more "natural" impression, which especially becomes obvious when listening to music. The benefits of deep insertion should not, however, be compromised by structural damage during insertion. The small cross section and the high flexibility of the new electrodes can help to ensure less traumatic insertions as demonstrated by patients' hearing preservation rate. This article is part of a Special Issue entitled .

Method to estimate the complete and two-turn cochlear duct length.

HYPOTHESIS: Using a linear measurement of the cochlea on a single radiographic image can reliably estimate the complete and two-turn cochlear duct length (CDL) in a normal human temporal bone. BACKGROUND: CDL is measured from the middle of the round window to the helicotrema. Histologic studies have shown the length of the organ of Corti (OC) to range from 25 to 35 mm. CDL measurements, performed either radiographically or histologically, are quite tedious and time-consuming. We propose equations that can reliably estimate both two-turn and complete CDL using a single computed tomography (CT) image. METHODS: Prior studies of CDL, measured either histologically or radiographically, were reviewed, which yielded distributions of CDL measured at the OC and the lateral wall of the cochlea. Using Escudé's third equation as a basis, we were able to extrapolate complete and two-turn CDL based on a CT scan measurement of the diameter of the basal turn (A). RESULTS: Using measurement A, the relationship of two-turn CDL measured at the OC is 2TL(oc) = 3.65(A-1) and for 2TL(i) = 3.65(A-0.7). The equation for estimation of complete CDL is CDL(oc) = 4.16A - 4 and for CDL(i) = 4.16A - 2.7. CONCLUSION: Using a single linear measurement from a CT scan image can reliably estimate the two-turn and complete CDLs in human temporal bones. The two-turn length represents the best compromise of cochlear coverage while minimizing intracochlear trauma for electrode insertions.

Gene expression pattern after insertion of dexamethasone-eluting electrode into the guinea pig cochlea.

A cochlear implant is an indispensable apparatus for a profound hearing loss patient. But insertion of the electrode entails a great deal of stress to the cochlea, and may cause irreversible damage to hair cells and related nerve structure. Although damage prevention effects of dexamethasone have been reported, long-term administration is difficult. In this study, we used a dexamethasone-eluting electrode in the guinea pig cochlea, and compared the gene expression after 7 days insertion with that of a normal electrode and non-surgically treated control by microarray. 40 genes were up-regulated 2-fold or more in the normal electrode group compared to the non-surgically treated group. Most of the up-regulated genes were associated with immune response and inflammation. In the dexamethasone-eluting group, compared to the normal electrode group, 7 of the 40 genes were further up-regulated, while 12 of them were down-regulated and there was a tendency to return to the non-surgical condition. 9 genes were down-regulated 2-fold or less with normal electrode insertion, and 4 of the 9 tended to return to the non-surgical condition in the dexamethasone-eluting group. These genes are certainly involved in the maintenance of the physiological functions of the cochlea. Our results indicate that the dexamethasone-eluting electrode will have an effect on the normalization of homeostasis in the cochlea.

In vitro and in vivo evaluation of a hydrogel reservoir as a continuous drug delivery system for inner ear treatment.

Fibrous tissue growth and loss of residual hearing after cochlear implantation can be reduced by application of the glucocorticoid dexamethasone-21-phosphate-disodium-salt (DEX). To date, sustained delivery of this agent to the cochlea using a number of pharmaceutical technologies has not been entirely successful. In this study we examine a novel way of continuous local drug application into the inner ear using a refillable hydrogel functionalized silicone reservoir. A PEG-based hydrogel made of reactive NCO-sP(EO-stat-PO) prepolymers was evaluated as a drug conveying and delivery system in vitro and in vivo. Encapsulating the free form hydrogel into a silicone tube with a small opening for the drug diffusion resulted in delayed drug release but unaffected diffusion of DEX through the gel compared to the free form hydrogel. Additionally, controlled DEX release over several weeks could be demonstrated using the hydrogel filled reservoir. Using a guinea-pig cochlear trauma model the reservoir delivery of DEX significantly protected residual hearing and reduced fibrosis. As well as being used as a device in its own right or in combination with cochlear implants, the hydrogel-filled reservoir represents a new drug delivery system that feasibly could be replenished with therapeutic agents to provide sustained treatment of the inner ear.