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.

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.

ObjectiveMulti-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 DesignMulti-centre temporal bone insertion studies.Materials and MethodsThe 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.ResultsFrequent 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°.ConclusionThe 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.

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 two 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 seven animals using the contralateral ear as a control. Results All animals had minimal postoperative vestibular signs and were eating within hours of surgery. Six out of six animals tested had normal postoperative sinusoidal gain. Six out of seven animals had symmetric postoperative velocity-step responses toward and away from the implanted ear. The one animal with significantly asymmetric velocity-step responses also had a significant sensorineural hearing loss. One control animal which underwent canal-plugging had substantial loss of the velocity-step response toward the canal-plugged ear. In five animals, intraoperative electrically-evoked vestibular compound action potential (ECAP) recordings facilitated electrode placement. Postoperatively, electrically evoked eye-movements were obtained from electrodes associated with an ECAP waveform. Hearing was largely preserved in six animals and lost in one animal. Conclusions It is possible to implant the vestibular system with prosthetic stimulating electrodes without loss of rotational sensitivity or hearing. Since 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 Meniere’s disease has begun.

The Journal of International Advanced Otology (J Int Adv Otol) is an international, peer reviewed, open access publication that is fully sponsored and owned by the European Academy of Otology and Neurotology and the Politzer Society. The journal is published triannually in April, August, and December and its publication language is English. The scope of the Journal is limited with otology, neurotology, audiology (excluding linguistics) and skull base medicine. The Journal of International Advanced Otology aims to publish manuscripts at the highest clinical and scientific level. J Int Adv Otol publishes original articles in the form of clinical and basic research, review articles, short reports and a limited number of case reports. Controversial patient discussions, communications on emerging technology, and historical issues will also be considered for publication. Target audience of J Int Adv Otol includes physicians and academics who work in the fields of otology, neurotology, audiology and skull base medicine.