Abstract
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.
Highlights
IntroductionDeep insertion of a straight electrode results in significant impact on the lateral cochlear wall and basilar membrane
The benefits of preserving residual hearing at the time of cochlear implantation to allow combined electric and acoustic stimulation have been well demonstrated
These included: (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?
Summary
Deep insertion of a straight electrode results in significant impact on the lateral cochlear wall and basilar membrane This has been demonstrated to cause rupture of the basilar membrane and can result in electrode displacement into scala vestibuli in some cases (Adunka and Kiefer, 2006; Finley et al, 2008). Clinical studies with both 10 mm (Gantz and Turner, 2004) and 16 mm (Lenarz et al, 2006; Büchner et al, 2009) hearing preservation straight electrodes manufactured by Cochlear Ltd, have achieved good hearing preservation both with cochleostomy and round window insertions. The shallower angular insertion depth of these electrodes (approximately 180–280°) means that the outcome with electric stimulation alone is potentially limited compared to the Contour AdvanceTM electrode, which typically achieves an insertion depth of 390–450° with excellent perimodiolar position when the Advance Off-Stylet insertion technique is used
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