A study of intra-cochlear electrodes and tissue interface by electrochemical impedance methods in vivo.

This paper presents methods, results and analysis for measurements of the electrochemical impedance of platinum electrodes (approximately 0.43 mm2) over a 6-month implantation in the cat cochlea. The study aimed to improve our understanding of the effects of tissue response on impedance behaviour. An increase in impedance in the post-operative period was evident with a rise of the distorted arc at high frequencies in the complex plane, correlating to anomalous charge transport at the electrode-tissue interface. The impedance at low frequencies generally showed a capacitive dispersion modelled as a constant phase element, indicating a blocking characteristic of the electrodes. The study suggests that a reduction and changes in composition of perilymph or extracellular fluid adjacent to the electrodes, as a consequence of tissue response, causes the elevated "contact impedance". This affects the efficiency and quality of neural stimulating electrodes and neural recording electrodes. The finding of the crucial role of perilymph or extracellular fluid thin layer provides a new strategy for surface materials of neural electrodes, which is discussed in the paper. The interface characteristics must be considered during interpretation of studies undertaken in vitro or in acute experiments in vivo, where physiological fluid is abundant.

Chronic electrical stimulation of the auditory nerve using high surface area (HiQ) platinum electrodes.

High surface area cochlear implant electrodes with much smaller geometric surface areas than current designs might be used in the future to increase the number of stimulating electrodes along the carrier. Potential problems with an increase in charge density for a common stimulus resulting from decreasing the geometric surface area would be reduced by the enlarged real surface area of such electrodes. Electrochemically modified (HiQ) platinum (Pt) electrodes, with a real surface area approximately 75 times greater than the current standard Pt electrodes of the same geometric size, had shown in vitro a low polarization (Z(pol)) and electrode impedance (Z(e)), as well as a low residual direct current (DC). In this study we examined the chronic performance of HiQ electrodes in cats, which were bilaterally implanted with a two-channel HiQ or standard Pt scala tympani electrode array and unilaterally stimulated for periods of up to 2390 h. Stimuli consisted of 50 micros/phase charge-balanced biphasic current pulses presented at 2000 pulses/s/channel with a 50% duty cycle. Electrode impedance (Z(e)), access resistance (R(a)) and polarization impedance (Z(pol)) were calculated from current and voltage measurements obtained periodically throughout the implantation period. Immediately following implantation HiQ electrodes showed a significantly smaller Z(pol), resulting in a reduced Z(e) (P<0.0001) compared to standard electrodes, while there was no significant difference between R(a) of both electrode designs (P=0.91). Subsequently, Z(e) generally increased mainly due to a rise in R(a), which dominated Z(e) and obliterated the effect of a lower Z(pol) on Z(e) in HiQ electrodes. Peak R(a) levels correlated closely (r=0.85) with the amount of intracochlear fibrous tissue found adjacent to the array. Following explantation of the array, voltage waveforms for both electrode designs recorded in saline were again very similar to those recorded immediately after implantation. Mean DC levels were consistently lower for HiQ electrodes compared with standard electrodes (22.45 nA vs 134.7 nA). Histopathological examination of corresponding cochlear sections comparing the stimulated test side with the unstimulated control side showed no significant difference (P>0.05) for either animals implanted with HiQ electrodes (n=6) or standard electrodes (n=2). Nor were there any significant differences between the spiral ganglion cell density of the basal turn implanted with HiQ or standard electrodes for both the stimulated test (P=0.31) and the unstimulated control side (P=0.84). Although these findings are based on a small group of animals implanted with standard electrodes (n=2), and those negative statistical results could potentially be due to the small sample size, similar spiral ganglion cell survival was found in a previous study of a larger group of animals using standard electrodes stimulated with the same stimulus paradigm as in the present study [Xu et al. (1997) Hear. Res. 105, 1-29]. Our data indicate that while some initial advantages of HiQ electrodes are lost during chronic implantation due to intracochlear fibrous tissue growth, low DC levels and the high surface area appear to be maintained, suggesting that HiQ electrodes may have important clinical applications.

The contour electrode array: safety study and initial patient trials of a new perimodiolar design.

OBJECTIVE: The aim of these studies was to investigate the insertion properties and safety of a new intracochlear perimodiolar electrode array design (Contour). BACKGROUND: An electrode array positioned close to the neural elements could be expected to reduce stimulation thresholds and might potentially reduce channel interaction. METHODS: Two sequential studies were conducted. In study 1, the Contour electrode array was inserted in 12 human temporal bones. After cochlear surface preparation, the position of the array was noted and the basilar membrane was examined for insertion damage. On the basis of the outcome of this temporal bone study, study 2 investigated the Contour array, mounted on a Nucleus CI-24 M device and implanted in three adult patients. RESULTS: Study I showed that in 10 temporal bones, the Contour array was positioned close to the modiolus, and the basilar membrane was intact. In the two remaining bones, the arrays had pierced the basilar membrane and were positioned in the scala vestibuli apical to the penetration. Statistical analysis showed an equivalent probability of insertion-induced damage of the two array designs. In study 2, image analysis indicated that the Contour electrodes were positioned closer to the modiolus than the standard Nucleus straight array. Lower T and C levels, but higher impedance values, were recorded from electrodes close to the modiolus. Initial speech perception data showed that all patients gained useful open-set speech perception, two patients achieving scores of 100% on sentence material 3 months postoperatively. CONCLUSIONS: The temporal bone studies showed the Contour electrode array to be generally positioned closer to the modiolus than the standard Nucleus straight array, and to have an equivalent probability of causing insertion-induced damage.

The role of radiographic phase-contrast imaging in the development of intracochlear electrode arrays.

OBJECTIVE: This study describes the application of a new radiographic imaging modality, phase-contrast radiography, to in vitro human temporal bone imaging and investigates its use in the development of new electrode arrays for cochlear implants. BACKGROUND: The development of perimodiolar electrode arrays for cochlear implants requires detailed information from postoperative radiologic assessment on the position of the array in relation to the cochlear structures. Current standard radiographic techniques provide only limited details. MATERIALS AND METHODS: Nucleus standard electrode arrays and perimodiolar Contour electrode arrays were implanted into the scala tympani of 11 human temporal bones. Both conventional and phase-contrast radiographs were taken of each temporal bone for comparative purposes. RESULTS: Phase-contrast imaging provides better visualization of anatomic details of the inner ear and of the structure of the intracochlear electrode array, and better definition of electrode location in relation to cochlear walls. CONCLUSION: Phase-contrast radiography offers significant improvement over conventional radiography in images of in vitro human temporal bones. It seems to be a valuable tool in the development of intracochlear electrode arrays and cochlear implant research. However, this new radiographic technique still requires certain computational and physics challenges to be addressed before its clinical use can be established.

The effect of handedness in tactile speech perception.

This study examined differential performance of normally hearing subjects using a tactile device on the dominant versus non-dominant hand. The study evaluated whether tactual sensitivity for non-speech stimuli was greater for the dominant hand as compared with the non-dominant hand, and secondly, whether there was an advantage for speech presented tactually to the dominant hand, resulting from a preferential pathway to the language processing area in the left cerebral hemisphere. Evaluations of threshold pulse width, dynamic ranges, paired electrode identification, and a closed-set tactual pattern discrimination test battery showed no difference in tactual sensitivity measures between the two hands. Speech perception was assessed with closed sets of vowels and consonants and with open-set Harvey Gardner (HG) words and Arthur Boothroyd (AB) words. Group mean scores were higher in each of the tactually aided conditions as compared with the unaided conditions for speech tests, with the exception of AB words in the tactile plus lip-reading plus audition/lip-reading plus audition condition on the right hand. Overall mean scores on the closed-set vowel test and on open-set HG and AB words were significantly higher for the tactually aided condition as compared with the unaided condition. Comparison of performance between the dominant and non-dominant hand showed a significant advantage for the dominant hand on the closed-set vowel test only. No significant differences between hands in either tactually aided or unaided conditions were evident for any of the other speech perception tests. Factors influencing this result could have been variations in degree of difficulty of the tests, the amount of training subjects received, or the training strategy employed. Although an advantage to presenting speech through the dominant hand may exist, it is unlikely to be great enough to outweigh possible restrictions on everyday use.

Speech perception using combinations of auditory, visual, and tactile information.

Four normally-hearing subjects were trained and tested with all combinations of a highly-degraded auditory input, a visual input via lipreading, and a tactile input using a multichannel electrotactile speech processor. The speech perception of the subjects was assessed with closed sets of vowels, consonants, and multisyllabic words; with open sets of words and sentences, and with speech tracking. When the visual input was added to any combination of other inputs, a significant improvement occurred for every test. Similarly, the auditory input produced a significant improvement for all tests except closed-set vowel recognition. The tactile input produced scores that were significantly greater than chance in isolation, but combined less effectively with the other modalities. The addition of the tactile input did produce significant improvements for vowel recognition in the auditory-tactile condition, for consonant recognition in the auditory-tactile and visual-tactile conditions, and in open-set word recognition in the visual-tactile condition. Information transmission analysis of the features of vowels and consonants indicated that the information from auditory and visual inputs were integrated much more effectively than information from the tactile input. The less effective combination might be due to lack of training with the tactile input, or to more fundamental limitations in the processing of multimodal stimuli.

Safety studies with the University of Melbourne multichannel electrotactile speech processor.

Results of safety investigations conducted as an integral part of the development of a multichannel electrotactile speech processor (Tickle Talker) are reported. Electrical parameters of the stimulus waveform, design of the electrode handset and cabling, and the electrical circuitry of the speech processor/stimulator and programming interface have been analyzed for potential risks. Constant current biphasic square pulses delivered to electrodes positioned on the skin surface over the digital nerve bundles were chosen to optimize the safety, comfort, and function of the electrotactile stimulus. The device was battery-powered, and the user circuit was isolated from earth-referenced sources. Each electrode was isolated by capacitive coupling, preventing DC leakage of current to the user circuit. Studies of finger temperature showed slight cooling of the skin on the fingers of both stimulated and unstimulated hands for individual subjects following electrotactile stimulation through the Tickle Talker. Subsequent analysis of finger and hand vascular circulation in five subjects showed slight reductions in hand blood flow in some individuals. The results did not demonstrate a significant mean decrease in hand or finger blood flow following electrotactile stimulation. No evidence of sympathetic involvement was found, nor were any changes in vascular structure of the hand such as those associated with Raynaud's disease found. Evidence suggests that the decrease in temperature found in the initial study may be due to a change in the ratio of blood flow between arteriovenous anastomoses and nutritive capillary beds. Studies of: 1) changes in mean threshold and comfortable pulse widths over time; and, 2) changes in tactual sensitivity as measured by hot/cold, sharp/dull, and two-point difference limen discrimination, did not detect any systematic change in peripheral nervous system function following electrotactile stimulation. Analysis of electroencephalogram (EEG) recordings taken during electrotactile stimulation, and after relatively long periods of experience with the device did not show any pathological changes which might be associated with epileptic foci. In summary, no contraindications to long-term use of the Tickle Talker were detected in the studies performed.

Use of a multichannel electrotactile speech processor by profoundly hearing-impaired children in a total communication environment.

As part of a larger subject group, four profoundly hearing-impaired children enrolled in a total communication educational program were fitted with the University of Melbourne's multichannel electrotactile speech processor (Tickle Talker). Sound detection thresholds for pure tones were at lower levels with the tactile device than with hearing aids, especially for high frequency sounds above 2 kHz. Two of the children also detected all speech sounds of the Ling five-sound test at normal conversational levels using only the Tickle Talker. The children were able to use tactile input to achieve higher scores on three speech feature subtests of the PLOTT test when using the Tickle Talker plus hearing aids as compared to hearing aids alone. Mean improvements were 22.4 percent on vowel length, 28 percent on vowel identification, and 35 percent on consonant manner. Improvements were also shown by individual children on the closed-set WIPI and open-set PBK word tests, and on the open-set BKB sentence test, when the Tickle Talker was combined with hearing aids, and with hearing aids and lipreading. Comparisons of these results with those of children using the Tickle Talker in other educational settings show that children in a total communication environment can potentially benefit to a similar degree from use of tactual input. Anecdotal reports from the children and school staff members indicated that daily use of the Tickle Talker did not interfere with the signing aspects of total communication.

Improved electrotactile speech processor: Tickle Talker.

The Tickle Talker, an eight-channel electrotactile speech processor, has been developed from continuing research at the University of Melbourne. The development of the device has focused on production of reliable speech-processing hardware, design of cosmetically and ergonometrically acceptable electrode transducers, implementation of acute and chronic biomedical studies demonstrating device safety, design and testing of alternative speech-encoding strategies to provide benefit to speech perception and production, and design and testing of appropriate training methods for optimizing benefits. The Tickle Talker has been shown to provide benefits in supplementing lipreading or aided residual hearing for hearing-impaired adults and children. Improvements in speech processing have resulted in an increase in benefits to speech perception, and open the way for more flexible approaches to encoding speech input. Continuing development of the electrode circuitry has now produced a device that is robust and has an extended battery life. Safety studies have clearly demonstrated that there are no long-term contraindications to device use. The results suggest that the device has a role to play in rehabilitation programs for severely and profoundly hearing-impaired adults and children.

Speech perception in children using the advanced Speak speech-processing strategy.

The Speak speech-processing strategy, developed by the University of Melbourne and commercialized by Cochlear Pty Limited for use in the new Spectra 22 speech processor, has been shown to provide improved speech perception for adults in both quiet and noisy situations. The present study evaluated the ability of children experienced in the use of the Multipeak (Mpeak) speech-processing strategy (implemented in the Nucleus Minisystem-22 cochlear implant) to adapt to and benefit from the advanced Speak speech-processing strategy (implemented in the Nucleus Spectra 22 speech processor). Twelve children were assessed using Mpeak and Speak over a period of 8 months. All of the children had over 1 year's previous experience with Mpeak, and all were able to score significantly on open-set word and sentence tests using the cochlear implant alone. Children were assessed with both live-voice and recorded speech materials, including Consonant-Nucleus-Consonant monosyllabic words and Speech Intelligibility Test sentences. Assessments were made in both quiet and in noise. Assessments were made at 3-week intervals to investigate the ability of the children to adapt to the new speech-processing strategy. For most of the children, a significant advantage was evident when using the Speak strategy as compared with Mpeak. For 4 of the children, there was no decrement in speech perception scores immediately following fitting with Speak. Eight of the children showed a small (10% to 20%) decrement in speech perception scores for between 3 and 6 weeks following the changeover to Speak. After 24 weeks' experience with Speak, 11 of the children had shown a steady increase in speech perception scores, with final Speak scores higher than for Mpeak. Only 1 child showed a significant decrement in speech perception with Speak, which did not recover to original Mpeak levels.

A comparison of two training strategies for speech recognition with an electrotactile speech processor.

Seven normally hearing adults were trained in the use of a multiple-channel electrotactile speech processor for 70 hours over a 6-month period. Two training strategies were used on each of the subjects: (1) analytic-plus-synthetic (AS), and (2) synthetic (S). The speech perception abilities of the subjects were assessed with closed sets of vowels and consonants, open sets of words and sentences, and speech tracking, for the tactile-plus-lipreading, tactile, and lipreading conditions. The subjects were tested on three separate occasions: (1) at the beginning of the study, (2) after 35 hours of training, and (3) after a further 35 hours of training. Wilcoxon matched-pair signed-ranks (MPSR) tests showed that improvements observed with both the AS and S strategies were significantly (p less than .05) greater than zero for most tests and conditions. The Wilcoxon MPSR test showed that the difference in improvements between the training strategies was significant for only the vowel and consonant tests in the tactile condition.

Phonemic information transmitted by a multichannel electrotactile speech processor.

A wearable electrotactile speech processor was evaluated in a study with seven normally hearing and four hearing-impaired subjects. The processor estimated the fundamental frequency, the second-formant frequency, and amplitude of the acoustic speech signal. These parameters were presented as a pattern of electrical pulses applied to eight electrodes positioned over the digital nerve bundles on one hand. The device was shown to provide useful information for the recognition of phonemes in closed sets of words using tactile information alone. The device also supplemented lipreading to improve the recognition of open-set words. The recognition of duration and first- and second-formant frequencies of vowels and the recognition of voicing and manner of consonants were improved over recognition with lipreading alone. Recognition of final consonants was improved more than recognition of initial consonants. These results indicate that the device may be useful to both severely and profoundly hearing-impaired people.

Preliminary evaluation of a multichannel electrotactile speech processor.

Speech discrimination testing, using both open- and closed-set materials, was carried out with four severely to profoundly hearing impaired adults and seven normally hearing subjects to assess performance of a wearable eight-channel electrotactile aid (Tickle Talker). Significant increases in speechtracking rates were noted for all subjects when using the electrotactile aid. After 70 h of training, mean tracking rate in the tactile plus lipreading condition was 55 words per minute (wpm), as compared with 36 wpm for lipreading alone, for the normally hearing group. For the hearing impaired group, the mean tracking rate in the aided condition was 37 wpm, as compared with 24 wpm for lipreading alone, following 35 h of training. Performance scores on Central Institute for the Deaf (CID) everyday sentences, Consonant Nucleus Consonant (CNC) words, and closed-set vowel and consonant identification were significantly improved when using the electrotactile aid. Performance scores, using the aid without lipreading, were well above chance on consonant and vowel identification and on elements of the Minimal Auditory Capabilities Battery. Two hearing impaired subjects have used the device satisfactorily in the home environment.