The partial tripolar electrode configuration is a relatively novel stimulation strategies that can generate more spatially focused electric fields than the commonly used monopolar configuration. Focused stimulation strategies should improve spectral resolution in cochlear implant users, but may also be more sensitive to local irregularities in the electrode-neuron interface. In this study, we develop a practical computer model of cochlear implant stimulation that can simulate neural activation in a simplified cochlear geometry and we relate the resulting patterns of neural activity to basic psychophysical measures. We examine how two types of local irregularities in the electrode-neuron interface, variations in spiral ganglion nerve density and electrode position within the scala tympani, affect the simulated neural activation patterns and how these patterns change with electrode configuration. The model shows that higher partial tripolar fractions activate more spatially restricted populations of neurons at all current levels and require higher current levels to excite a given number of neurons. We find that threshold levels are more sensitive at high partial tripolar fractions to both types of irregularities, but these effects are not independent. In particular, at close electrode-neuron distances, activation is typically more spatially localized which leads to a greater influence of neural dead regions.

Hypothesis A functional vestibular prosthesis can be implanted in human such that electrical stimulation of each semicircular canal produces canal-specific eye movements while preserving vestibular and auditory function. Background A number of vestibular disorders could be treated with prosthetic stimulation of the vestibular end organs. We have previously demonstrated in rhesus monkeys that a vestibular neurostimulator, based on the Nucleus Freedom cochlear implant, can produce canal-specific electrically evoked eye movements while preserving auditory and vestibular function. An investigational device exemption has been obtained from the FDA to study the feasibility of treating uncontrolled Ménière’s disease with the device. Methods The UW/Nucleus vestibular implant was implanted in the perilymphatic space adjacent to the three semicircular canal ampullae of a human subject with uncontrolled Ménière’s disease. Pre and postoperative vestibular and auditory function were assessed. Electrically evoked eye movements were measured at two time points postoperatively. Results Implantation of all semicircular canals was technically feasible. Horizontal canal and auditory function were largely, but not totally, lost. Electrode stimulation in two of three canals resulted in canal-appropriate eye movements. Over time, stimulation thresholds increased. Conclusions Prosthetic implantation of the semicircular canals in humans is technically feasible. Electrical stimulation resulted in canal-specific eye movements, although thresholds increased over time. Preservation of native auditory and vestibular function, previously observed in animals, was not demonstrated in a single subject with advanced Ménière’s disease.

A rapid threshold measurement procedure, based on Bekesy tracking, is proposed and evaluated for use with cochlear implants (CIs). Fifteen postlingually deafened adult CI users participated. Absolute thresholds for 200-ms trains of biphasic pulses were measured using the new tracking procedure and were compared with thresholds obtained with a traditional forced-choice adaptive procedure under both monopolar and quadrupolar stimulation. Virtual spectral sweeps across the electrode array were implemented in the tracking procedure via current steering, which divides the current between two adjacent electrodes and varies the proportion of current directed to each electrode. Overall, no systematic differences were found between threshold estimates with the new channel sweep procedure and estimates using the adaptive forced-choice procedure. Test–retest reliability for the thresholds from the sweep procedure was somewhat poorer than for thresholds from the forced-choice procedure. However, the new method was about 4 times faster for the same number of repetitions. Overall the reliability and speed of the new tracking procedure provides it with the potential to estimate thresholds in a clinical setting. Rapid methods for estimating thresholds could be of particular clinical importance in combination with focused stimulation techniques that result in larger threshold variations between electrodes.

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.

Objective We recorded intra-operative and post-operative electrically-evoked compound action potentials (ECAPs) in rhesus monkeys implanted with a vestibular neurostimulator. The objectives were to correlate the generation of slow-phase nystagmus or eye twitches induced by electrical stimulation of the implanted semicircular canal with the presence or absence of the vestibular ECAP responses, and to assess the effectiveness of ECAP monitoring during surgery to guide surgical insertion of electrode arrays into the canals. Design Four rhesus monkeys (a total of seven canals) were implanted with a vestibular neurostimulator modified from the Nucleus Freedom™ cochlear implant. ECAP recordings were obtained during surgery or at various intervals post-surgery using the Neural Response Telemetry™ feature of the clinical Custom Sound EP™ software. Eye movements during electrical stimulation of individual canals were recorded with a scleral search coil system in the same animals. Results Measurable vestibular ECAPs were observed intra-operatively or post-operatively in three implanted animals. Robust and sustained ECAPs were obtained in three monkeys at the test intervals of 0, 7, or >100 days post implantation surgery. In all three animals, stimulation with electrical pulse trains produced measurable eye movements in a direction consistent with the vestibulo-ocular reflex from the implanted semicircular canal. In contrast, electrically-evoked eye movements could not be measured in three of the seven implanted canals none of which produced distinct vestibular ECAPs. In two animals, ECAP waveforms were systematically monitored during surgery and the procedure proved crucial to the success of vestibular implantation. Conclusions Vestibular ECAPs exhibit similar morphology and growth characteristics to cochlear ECAPs from human cochlear implant patients. The ECAP measure is well correlated with the functional activation of eye movements by electrical stimulation post implantation surgery. The intra-operative ECAP recording technique is an efficient tool to guide the placement of electrode array into the semicircular canals.