Frank Risi

Temporal Bone Results and Hearing Preservation with a New Straight Electrode

Due to improved technology, cochlear implant (CI) candidacy has been widened towards patients with usable residual hearing in the low frequency range. These patients might benefit from additional acoustic amplification provided that residual hearing can be preserved with cochlear implantation. To provide a high probability of hearing preservation, a new electrode array was designed and developed at the Medizinische Hochschule Hannover. This ‘Hybrid-L’ electrode array has 22 electrodes spread over 15 mm with an overall insertion depth of 16 mm. The straight electrode with modiolus facing contacts is designed for a round window insertion. It shall provide the full range of the currently most advanced Nucleus CI system. A temporal bone study demonstrated the favorable insertion characteristics and minimized trauma to intracochlear structures. Compared to standard CI electrodes especially no basilar membrane perforation could be found. So far, 4 patients have been implanted and residual hearing could be preserved. One patient was fitted and showed a marked additional benefit from the electroacoustic stimulation compared to either acoustic or electrical stimulation alone. These results are very encouraging towards a concept of reliable hearing preservation with cochlear implantation.

Comparison of Round Window and Cochleostomy Approaches with a Prototype Hearing Preservation Electrode

Introduction: Preservation of residual hearing in cochlear implant recipients has been demonstrated to be possible and provides the potential benefit of combined electric and acoustic auditory stimulation. A prototype 16-mm multichannel array has been designed to facilitate placement of 22 electrodes without damage to intracochlear structures. The electrode array is suitable for insertion via the round window membrane (RWM) or a small cochleostomy. Aim: To evaluate the insertion trajectory and the presence of trauma to intracochlear structures with the prototype electrode inserted by either the RWM or a scala tympani cochleostomy. Materials and Methods: Eighteen fresh frozen human temporal bones were prepared for cochlear implantation using a standard transmastoid facial recess technique. Twelve electrodes were implanted at the University of Melbourne and 6 at the Medizinische Hochschule Hannover. In Melbourne fluoroscopy was used to monitor the insertions. Twelve prototype electrodes were inserted via the RWM. A further 6 electrodes were inserted via a small scala tympani cochleostomy. The cochleostomy was sited inferior to the RWM to avoid trauma to the basilar membrane and spiral ligament. Specimens were embedded and fixed with acrylic resin and the cochleae then examined histologically at 200-µm intervals using a grinding and polishing technique. Results: Full insertion of the electrode was achieved without significant resistance in all RWM and cochleostomy specimens. In two RWM specimens fold-over of the electrode tip occurred, and in one specimen the electrode penetrated the spiral ligament to lie in an ‘endosteal ‘position. In one cochleostomy specimen the electrode was rotated within the cochlea to face laterally rather than towards the modiolus. The final electrode position differed for the two groups, with the electrodes inserted via the RWM lying in a more perimodiolar position along the first part of the basal turn. The average depth of insertion was 240° for the RWM electrodes and 255° for the cochleostomy electrodes. Histologic examination showed no damage in any specimen to the modiolus, osseous spiral lamina or basilar membrane. Conclusions: A prototype hearing preservation electrode array was inserted by either a RWM or a scala tympani cochleostomy without evidence of significant intracochlear trauma.

Implantation of the Semicircular Canals with Preservation of Hearing and Rotational Sensitivity: a vestibular neurostimulator suitable for clinical research

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.

Reliability of cone beam computed tomography in scalar localization of the electrode array: a radio histological study

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.

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

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.

The use of cone-beam computed tomography to determine cochlear implant electrode position in human temporal bones.

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 &mgr;m voxel size) and were then processed for histologic sectioning (500 &mgr;m 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.

Development of a safe dexamethasone-eluting electrode array for cochlear implantation

Abstract 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.

Seeing electrode movement in the cochlea Micro-focus fluoroscopy — A great tool for electrode development

Abstract The aim of this study was to utilise micro-focus X-ray fluoroscopy for viewing electrode movement in the cochlea. Various prototypes of newly designed cochlear implant electrodes were evaluated during insertion studies on human cadaver temporal bones. The magnified fluoroscopic images were observed in real-time and recorded for retrospective studies. In 30 insertions of hearing preservation (Hybrid-L) arrays, fluoroscopy provided crucial information on the tip design, length of array and stiffening stylet. In 44 insertions of Contour Advance enhanced (CAe) arrays, the length, curvature, depth of insertion and degree of stiffness were assessed. CAe arrays were successfully inserted to the designated depth and positioned close to the modiolus. High quality microfocus fluoroscopic images of electrode movement in the cochlea greatly assisted in the validation of newly designed intra-cochlear electrode arrays. Copyright

Long-term electrode impedance changes and failure prevalence in cochlear implants

Abstract 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.

The use of cone beam imaging to determine cochlear implant electrode position in human temporal bones

Abstract This paper describes the outcomes of cochlear implantation in eight cadaveric temporal bones using cone-beam CT imaging and histological examination with respect to scalar position of the electrode array.