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      Development and evaluation of the modiolar research array – multi-centre collaborative study in human temporal bones

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          Abstract

          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.

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          Most cited references17

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          Role of electrode placement as a contributor to variability in cochlear implant outcomes.

          Suboptimal cochlear implant (CI) electrode array placement may reduce presentation of coded information to the central nervous system and, consequently, limit speech recognition. Generally, mean speech reception scores for CI recipients are similar across different CI systems, yet large outcome variation is observed among recipients implanted with the same device. These observations suggest significant recipient-dependent factors influence speech reception performance. This study examines electrode array insertion depth and scalar placement as recipient-dependent factors affecting outcome. Scalar location and depth of insertion of intracochlear electrodes were measured in 14 patients implanted with Advanced Bionics electrode arrays and whose word recognition scores varied broadly. Electrode position was measured using computed tomographic images of the cochlea and correlated with stable monosyllabic word recognition scores. Electrode placement, primarily in terms of depth of insertion and scala tympani versus scala vestibuli location, varies widely across subjects. Lower outcome scores are associated with greater insertion depth and greater number of contacts being located in scala vestibuli. Three patterns of scalar placement are observed suggesting variability in insertion dynamics arising from surgical technique. A significant portion of variability in word recognition scores across a broad range of performance levels of CI subjects is explained by variability in scalar location and insertion depth of the electrode array. We suggest that this variability in electrode placement can be reduced and average speech reception improved by better selection of cochleostomy sites, revised insertion approaches, and control of insertion depth during surgical placement of the array.
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            The size of the cochlea and predictions of insertion depth angles for cochlear implant electrodes.

            To establish normative data on the size of the basal turn of the cochlea using high-resolution computed tomography of the temporal bone in adults and children. To determine whether final insertion depth angle for a perimodiolar cochlear implant electrode varies according to cochlear size. Forty-two patients screened for cochlear anomaly using computed tomography were randomly selected from patients with otologic disease. Reconstruction of the full basal turn was performed for both ears using a 1.0-mm layer, minimum intensity projection. The largest distance from the round window to the lateral wall (distance A) and the perpendicular distance (B) were measured. Distances were averaged between ears for each individual. In addition, 15 patients were implanted with the Nucleus 24 Contour Advance electrode array using a linear insertion depth of either 17 mm (n = 9) or 19 mm (n = 6). Postoperative X-rays were analyzed using the method of Xu et al. [Am J Otol 2000;21:49-56] to obtain the insertion depth angles for individual electrodes. Mean distance A was 9.23 mm (SD = 0.53, range 7.9-10.8 mm). Perpendicular distance B was significantly correlated with distance A (r2 = 0.57, p 5.0 mm variation in the length of the lateral wall to the point consistent with an insertion depth angle of 360 degrees . Cochlear size influenced final insertion depth angles obtained for the perimodiolar Nucleus 24 Contour Advance electrode. Copyright (c) 2006 S. Karger AG, Basel.
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              Preservation of hearing in cochlear implant surgery: advantages of combined electrical and acoustical speech processing.

              This study documents the importance of preserving residual low-frequency acoustic hearing as those with more residual hearing are selected for cochlear implantation. Surgical strategies used for hearing preservation with a short hybrid cochlear implant are outlined. The benefits of preserved residual low-frequency hearing, improved word understanding in noise, and music appreciation are described. Multicenter, prospective, single-subject design. Records were reviewed of 21 individuals participating in an Food and Drug Administration (FDA) feasibility clinical trial who have received an Iowa/Nucleus 10 mm electrode. A second group of subjects receiving implants at the University of Iowa that have used the 10 mm device between 2 years and 6 months were also reviewed. Outcome measures included standardized tests of monosyllabic word understanding, spondees in noise, and common melody recognition. Low-frequency hearing was maintained in all individuals immediately postoperative. One subject lost hearing at 2.5 months postoperative after a viral infection. The group has averaged a loss of -9 dB low-frequency acoustic hearing between 125 and 1,000 Hz. Monosyllabic word understanding scores at 6 months for a group being followed for an FDA clinical trial using the implant plus hearing aids was 69% correct. For the long-term group receiving implants at Iowa, monosyllabic word understanding in those who have used the device between 6 months and 2 years is 79%. Other important findings include improved recognition of speech in noise (9 dB improvement) as compared with standard cochlear implant recipients who were matched for speech recognition in quiet and near normal recognition of common melodies. The surgical strategies outlined have been successful in preservation of low-frequency hearing in 96% of individuals. Combined electrical and acoustical speech processing has enabled this group of volunteers to gain improved word understanding as compared with their preoperative hearing with bilateral hearing aids and a group of individuals receiving a standard cochlear implant with similar experience with their device. The improvement of speech in noise and melody recognition is attributed to the ability to distinguish fine pitch differences as the result of preserved residual low-frequency acoustic hearing. Preservation of low-frequency acoustic hearing is important for improving speech in noise and music appreciation for the hearing impaired, both of which are important in real-life situations.
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                Author and article information

                Journal
                Cochlear Implants Int
                CIM
                Cochlear Implants International
                Maney Publishing
                1467-0100
                1754-7628
                August 2011
                : 12
                : 3
                : 129-139
                Affiliations
                [1 ]University of Melbourne and HEARing CRC, Melbourne, Australia
                [2 ]Universität Freiburg, Germany
                [3 ]Medizinische Hochschule Hannover, Germany
                [4 ]Hôpital Purpan, Toulouse, France
                [5 ]New York University, USA
                [6 ]University of Texas, Southwestern, USA
                [7 ]The University of Iowa Carver College of Medicine, USA
                [8 ]Cochlear Limited, Sydney, Australia
                Author notes
                Correspondence to: Robert J S Briggs, Department of Otolaryngology, University of Melbourne, 32 Gisbourne Street, East Melbourne 3002, Australia. Email: rjbriggs@ 123456netspace.net.au
                Article
                cim-12-129
                10.1179/1754762811Y0000000007
                3159433
                21917200
                e1720d15-b7c5-4a56-86aa-aca5c25c3694
                © W.S. Maney & Son Ltd 2011

                This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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                Categories
                Articles

                Transplantation
                cochlear implant,hearing preservation,temporal bone,electrode,cochleostomy,round window,perimodiolar

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