Combining Intraoperative Electrocochleography with Robotics-Assisted Electrode Array Insertion.

OBJECTIVE: To describe the use of robotics-assisted electrode array (EA) insertion combined with intraoperative electrocochleography (ECochG) in hearing preservation cochlear implant surgery. STUDY DESIGN: Prospective, single-arm, open-label study. SETTING: All procedures and data collection were performed at a single tertiary referral center. PATIENTS: Twenty-one postlingually deaf adult subjects meeting Food and Drug Administration indication criteria for cochlear implantation with residual acoustic hearing defined as thresholds no worse than 65 dB at 125, 250, and 500 Hz. INTERVENTION: All patients underwent standard-of-care unilateral cochlear implant surgery using a single-use robotics-assisted EA insertion device and concurrent intraoperative ECochG. MAIN OUTCOME MEASURES: Postoperative pure-tone average over 125, 250, and 500 Hz measured at initial activation and subsequent intervals up to 1 year afterward. RESULTS: Twenty-two EAs were implanted with a single-use robotics-assisted insertion device and simultaneous intraoperative ECochG. Fine control over robotic insertion kinetics could be applied in response to changes in ECochG signal. Patients had stable pure-tone averages after activation with normal impedance and neural telemetry responses. CONCLUSIONS: Combining robotics-assisted EA insertion with intraoperative ECochG is a feasible technique when performing hearing preservation implant surgery. This combined approach may provide the surgeon a means to overcome the limitations of manual insertion and respond to cochlear feedback in real-time.

Evaluation of Real-Time Intracochlear Electrocochleography for Guiding Cochlear Implant Electrode Array Position.

This study evaluates intracochlear electrocochleography (ECochG) for real-time monitoring during cochlear implantation. One aim tested whether adjusting the recording electrode site would help differentiate between atraumatic and traumatic ECochG amplitude decrements. A second aim assessed whether associations between ECochG amplitude decrements and post-operative hearing loss were weaker when considering hearing sensitivity at the ECochG stimulus frequency compared to a broader frequency range. Eleven adult cochlear implant recipients who were candidates for electro-acoustic stimulation participated. Single-frequency (500-Hz) ECochG was performed during cochlear implantation; the amplitude of the first harmonic of the difference waveform was considered. Post-operative hearing preservation at 500 Hz ranged from 0 to 94%. The expected relationship between ECochG amplitude decrements and hearing preservation was observed, though the trend was not statistically significant, and predictions were grossly inaccurate for two participants. Associations did not improve when considering alternative recording sites or hearing sensitivity two octaves above the ECochG stimulus frequency. Intracochlear location of a moving recording electrode is a known confound to real-time interpretation of ECochG amplitude fluctuations, which was illustrated by the strength of the correlation with ECochG amplitude decrements. Multiple factors contribute to ECochG amplitude patterns and to hearing preservation; these results highlight the confounding influence of intracochlear recording electrode location on the ECochG.

Longitudinal Electrocochleography as an Objective Measure of Serial Behavioral Audiometry in Electro-Acoustic Stimulation Patients.

OBJECTIVE: Minimally traumatic surgical techniques and advances in cochlear implant (CI) electrode array designs have allowed acoustic hearing present in a CI candidate prior to surgery to be preserved postoperatively. As a result, these patients benefit from combined electric-acoustic stimulation (EAS) postoperatively. However, 30% to 40% of EAS CI users experience a partial loss of hearing up to 30 dB after surgery. This additional hearing loss is generally not severe enough to preclude use of acoustic amplification; however, it can still impact EAS benefits. The use of electrocochleography (ECoG) measures of peripheral hair cell and neural auditory function have shed insight into the pathophysiology of postimplant loss of residual acoustic hearing. The present study aims to assess the long-term stability of ECoG measures and to establish ECoG as an objective method of monitoring residual hearing over the course of EAS CI use. We hypothesize that repeated measures of ECoG should remain stable over time for EAS CI users with stable postoperative hearing preservation. We also hypothesize that changes in behavioral audiometry for EAS CI users with loss of residual hearing should also be reflected in changes in ECoG measures. DESIGN: A pool of 40 subjects implanted under hearing preservation protocol was included in the study. Subjects were seen at postoperative visits for behavioral audiometry and ECoG recordings. Test sessions occurred 0.5, 1, 3, 6, 12 months, and annually after 12 months postoperatively. Changes in pure-tone behavioral audiometric thresholds relative to baseline were used to classify subjects into two groups: one group with stable acoustic hearing and another group with loss of acoustic hearing. At each test session, ECoG amplitude growth functions for several low-frequency stimuli were obtained. The threshold, slope, and suprathreshold amplitude at a fixed stimulation level was obtained from each growth function at each time point. Longitudinal linear mixed effects models were used to study trends in ECoG thresholds, slopes, and amplitudes for subjects with stable hearing and subjects with hearing loss. RESULTS: Preoperative, behavioral audiometry indicated that subjects had an average low-frequency pure-tone average (125 to 500 Hz) of 40.88 ± 13.12 dB HL. Postoperatively, results showed that ECoG thresholds and amplitudes were stable in EAS CI users with preserved residual hearing. ECoG thresholds increased (worsened) while ECoG amplitudes decreased (worsened) for those with delayed hearing loss. The slope did not distinguish between EAS CI users with stable hearing and subjects with delayed loss of hearing. CONCLUSIONS: These results provide a new application of postoperative ECoG as an objective tool to monitor residual hearing and understand the pathophysiology of delayed hearing loss. While our measures were conducted with custom-designed in-house equipment, CI companies are also designing and implementing hardware and software adaptations to conduct ECoG recordings. Thus, postoperative ECoG recordings can potentially be integrated into clinical practice.

Neural Correlates of Vocal Auditory Feedback Processing: Unique Insights from Electrocorticography Recordings in a Human Cochlear Implant User.

There is considerable interest in understanding cortical processing and the function of top-down and bottom-up human neural circuits that control speech production. Research efforts to investigate these circuits are aided by analysis of spectro-temporal response characteristics of neural activity recorded by electrocorticography (ECoG). Further, cortical processing may be altered in the case of hearing-impaired cochlear implant (CI) users, as electric excitation of the auditory nerve creates a markedly different neural code for speech compared with that of the functionally intact hearing system. Studies of cortical activity in CI users typically record scalp potentials and are hampered by stimulus artifact contamination and by spatiotemporal filtering imposed by the skull. We present a unique case of a CI user who required direct recordings from the cortical surface using subdural electrodes implanted for epilepsy assessment. Using experimental conditions where the subject vocalized in the presence (CIs ON) or absence (CIs OFF) of auditory feedback, or listened to playback of self-vocalizations without production, we observed ECoG activity primarily in γ (32-70 Hz) and high γ (70-150 Hz) bands at focal regions on the lateral surface of the superior temporal gyrus (STG). High γ band responses differed in their amplitudes across conditions and cortical sites, possibly reflecting different rates of stimulus presentation and differing levels of neural adaptation. STG γ responses to playback and vocalization with auditory feedback were not different from responses to vocalization without feedback, indicating this activity reflects not only auditory, but also attentional, efference-copy, and sensorimotor processing during speech production.

Successful Hearing Preservation After Reimplantation of a Failed Hybrid Cochlear Implant.

Objective: The purpose of this case study was to demonstrate hearing preservation of a subject who was implanted with a 10-mm short electrode cochlear implant that was determined to be malfunctioning at 6 months postimplantation and was explanted and reimplanted with a 16-mm short electrode device.Study Design: Single-subject case study.Setting: Research hospital.Patient: A 60-year old female with a history of gradual progressive bilateral steeply sloping sensorineural hearing loss.Intervention: Rehabilitative.Main Outcome Measure(s): Audiometric data and speech perception in quiet and in noise were collected pre- and postoperatively at 3 and 6 months with the 10-mm short electrode device and pre-explantation and postoperatively at 3, 6, and 12 months with the 16-mm short electrode device.Results: Functional hearing preservation was accomplished following surgical implantation of both short electrode devices. Overall, the subject had a 22 dB HL total shift in pure-tone-average (0.125­1 kHz) after two cochlear implant surgeries. Speech perception growth was limited over the 6 months the subject was implanted with the 10-mm short electrode device. After 3 months of experience with the 16-mm short electrode device, the subject experienced significant improvements in both speech perception in quiet and in noise.Conclusions: The inner ear might be more robust than once thought, as was determined through preservation of residual hearing after implantation of two hearing preservation cochlear implants and one device explantation. Furthermore, it is important that hearing professionals remain cognizant of unusual speech perception patterns associated with the cochlear implant. Key Words: Hearing preservation­Residual hearing­Short electode. [Corrected]

Hearing Loss After Activation of Hearing Preservation Cochlear Implants Might Be Related to Afferent Cochlear Innervation Injury.

OBJECTIVE: Characterize hearing loss (HL) after hearing preservation cochlear implantation and determine the association between high charge electrical stimulation (ES) and late loss of acoustic hearing. METHODS: A retrospective cohort analysis of all hearing preservation implantees at our center (n = 42) assayed HL as a function of maximum charge. We analyzed serial audiometry from 85 patients enrolled in the multicenter Hybrid S8 trial to detail the hearing loss greater than 1 month after implantation. Cochleotypic explant cultures were used to assess susceptibility to high levels of ES. RESULTS: Early HL after implantation tends to be mild and averages 12.2 dB. After activation of the Hybrid S8 device, 17 (20%) of 85 patients experienced acceleration of HL. Compared with the majority of patients who did not lose significant hearing after activation, these patients experienced more severe HL at 1 year. Five patients implanted at our center experienced acceleration of HL after high charge exposure. In patients implanted at our center, high charge was associated with late HL (Pearson 0.366, p = 0.016). In rat cochleotypic explants, high voltage ES damaged afferent nerve fibers, reflected by blebbing and a 50% reduction in the number of fibers innervating the organ of Corti. In contrast, hair cells displayed only minor differences in cell number and morphology. CONCLUSIONS: Based on clinical and in vitro data, we theorize that the combination of acoustic amplification and ES in the setting of intact hair cells and neural architecture may contribute, in part, to cochlear toxicity, perhaps by damaging the afferent innervation.

Direct recordings from the auditory cortex in a cochlear implant user.

Electrical stimulation of the auditory nerve with a cochlear implant (CI) is the method of choice for treatment of severe-to-profound hearing loss. Understanding how the human auditory cortex responds to CI stimulation is important for advances in stimulation paradigms and rehabilitation strategies. In this study, auditory cortical responses to CI stimulation were recorded intracranially in a neurosurgical patient to examine directly the functional organization of the auditory cortex and compare the findings with those obtained in normal-hearing subjects. The subject was a bilateral CI user with a 20-year history of deafness and refractory epilepsy. As part of the epilepsy treatment, a subdural grid electrode was implanted over the left temporal lobe. Pure tones, click trains, sinusoidal amplitude-modulated noise, and speech were presented via the auxiliary input of the right CI speech processor. Additional experiments were conducted with bilateral CI stimulation. Auditory event-related changes in cortical activity, characterized by the averaged evoked potential and event-related band power, were localized to posterolateral superior temporal gyrus. Responses were stable across recording sessions and were abolished under general anesthesia. Response latency decreased and magnitude increased with increasing stimulus level. More apical intracochlear stimulation yielded the largest responses. Cortical evoked potentials were phase-locked to the temporal modulations of periodic stimuli and speech utterances. Bilateral electrical stimulation resulted in minimal artifact contamination. This study demonstrates the feasibility of intracranial electrophysiological recordings of responses to CI stimulation in a human subject, shows that cortical response properties may be similar to those obtained in normal-hearing individuals, and provides a basis for future comparisons with extracranial recordings.

Relationships between electrically evoked potentials and loudness growth in bilateral cochlear implant users.

OBJECTIVES: The goals of this study were (1) to describe the relationship between electrically evoked compound action potential (ECAP) and electrically evoked auditory brainstem response (EABR) amplitude growth functions and loudness growth functions in bilateral cochlear implant (CI) users, and (2) to determine whether matching the stimulus levels in the two ears of bilateral CI users based on equal ECAP amplitude, EABR amplitude, or current level resulted in the smallest discrepancy in loudness rating across the two ears. DESIGN: Ten adult, bilateral CI users participated in this study. The stimulus used to elicit loudness judgments and generate ECAP and EABR growth functions was a train of biphasic current pulses (32 µs/phase) presented at a rate of 23 pps. Loudness growth functions were obtained with a method of constant stimuli. ECAPs were measured using the implant telemetry system. EABR growth functions were recorded using surface electrodes and standard averaging techniques. Both ears of each subject were tested. For each ear, ECAP, EABR, and loudness functions were recorded using both an apical and basal stimulating electrode. Both the physiologic and psychophysical growth functions were fit using linear regression techniques. RESULTS: Comparison of the regression equations obtained for the two ears revealed that stimulus levels that yielded approximately equal ECAP amplitudes in the two ears were judged to differ in loudness, on average, by 20% for electrode 3 and 14% for electrode 13. Stimulation levels that evoked similar amplitude EABRs differed in loudness, on average, by 50% for electrode 3 and 13% for electrode 13. Matched stimulus current levels were judged to differ in loudness, on average, by 14% for electrode 3 and 16% for electrode 13. No significant differences in loudness discrepancy across ears derived from equal amplitude ECAP, EABR, or matched current levels were found. CONCLUSIONS: This study demonstrated that stimuli that evoke equal amplitude neural responses in both ears of a bilateral CI user or which are matched in current level cannot be assumed to be perceived as equally loud. No statistically significant differences in accuracy were found between ECAP, EABR, or matched current levels or between the basal and apical electrode in approximations of equal loudness.

The relationship between electrically evoked compound action potential and speech perception: a study in cochlear implant users with short electrode array.

OBJECTIVES: To determine the extent to which electrically evoked compound action potential (ECAP) measurements were related with speech perception performance in implant users with a short electrode array and to investigate the relationship between ECAP measures and performance according to specific devices. DESIGN: Prospective study. SETTING: Tertiary referral center. PATIENTS: Seventeen Hybrid cochlear implant users were tested in this study. Subjects were divided into 2 groups: 8 using the Nucleus Hybrid M and 9 using the Nucleus Hybrid RE. In addition, 21 Nucleus Freedom long electrode implant (CI24RE) users also were tested to compare with the results of the old device (CI24M). MAIN OUTCOME MEASURES: ECAP growth functions were recorded using either an interphase gap (IPG) of 8 or 45 mus. We then calculated the slope of the growth function and changes in sensitivity with IPG. For each subject, these measures were compared with performance on tests of word recognition. RESULTS: The changes in sensitivity using 2 IPGs showed no correlation with the results of word recognition test in Hybrid cochlear implant users. In contrast, relatively strong correlations have been found between the slope of ECAP growth functions and performance on word recognition test. Additionally, when we separate the results of Hybrid M and RE, the slopes of ECAP growth functions from only Hybrid RE CI recipients were significantly correlated with speech performance. The slopes of ECAP growth function in CI24RE users with long electrode also were significantly correlated with performance. However, comparing between 2 independent correlations in RE devices, correlation was higher in Hybrid RE group. CONCLUSION: The results presented in this article support the view that slope of the ECAP growth can show significant correlation to performance with a cochlear implant. Furthermore, these results suggest that the strength of the correlation may be related to the specific device. These results suggest that ECAP measures may be useful in developing a test to predict outcomes with the implant.

Comparison of electrically evoked compound action potential thresholds and loudness estimates for the stimuli used to program the Advanced Bionics cochlear implant.

BACKGROUND: In the mid-1990s, Cochlear Corporation introduced a cochlear implant (CI) to the market that was equipped with hardware that made it possible to record electrically evoked compound action potentials (ECAPs) from CI users of all ages. Over the course of the next decade, many studies were published that compared ECAP thresholds with levels used to program the speech processor of the Nucleus CI. In 2001 Advanced Bionics Corporation introduced the Clarion CII cochlear implant (the Clarion CII internal device is also known as the CII Bionic Ear). This cochlear implant was also equipped with a system that allowed measurement of the ECAP. While a great deal is known about how ECAP thresholds compare with the levels used to program the speech processor of the Nucleus CI, relatively few studies have reported comparisons between ECAP thresholds and the levels used to program the speech processor of the Advanced Bionics CI. PURPOSE: To explore the relationship between ECAP thresholds and behavioral measures of perceptual dynamic range for the range of stimuli commonly used to program the speech processor of the Advanced Bionics CI. RESEARCH DESIGN: This prospective and experimental study uses correlational and descriptive statistics to define the relationship between ECAP thresholds and perceptual dynamic range measures. STUDY SAMPLE: Twelve postlingually deafened adults participated in this study. All were experienced users of the Advanced Bionics CI system. DATA COLLECTION AND ANALYSIS: ECAP thresholds were recorded using the commercially available SoundWave software. Perceptual measures of threshold (T-level), most comfortable level (M-level), and maximum comfortable level (C-level) were obtained using both "tone bursts" and "speech bursts." The relationship between these perceptual and electrophysiological variables was defined using paired t-tests as well as correlation and linear regression. RESULTS: ECAP thresholds were significantly correlated with the perceptual dynamic range measures studied; however, correlations were not strong. Analysis of the individual data revealed considerable discrepancy between the contour of ECAP threshold versus electrode function and the behavioral loudness estimates used for programming. CONCLUSION: ECAP thresholds recorded from Advanced Bionics cochlear implant users always indicated levels where the programming stimulus was audible for the listener. However, the correlation between ECAP thresholds and M-levels (the primary metric used to program the speech processor of the Advanced Bionics CI), while statistically significant, was quite modest. If programming levels are to be determined on the basis of ECAP thresholds, care should be taken to ensure that stimulation is not uncomfortably loud, particularly on the basal electrodes in the array.

The effect of changes in stimulus level on electrically evoked cortical auditory potentials.

OBJECTIVES: The purpose of this study was to determine whether the electrically evoked acoustic change complex (EACC) could be used to assess sensitivity to changes in stimulus level in cochlear implant (CI) recipients and to investigate the relationship between EACC amplitude and rate of growth of the N1-P2 onset response with increases in stimulus level. DESIGN: Twelve postlingually deafened adults using Nucleus CI24 CIs participated in this study. Nucleus Implant Communicator (NIC) routines were used to bypass the speech processor and to control the stimulation of the implant directly. The stimulus consisted of an 800 msec burst of a 1000 pps biphasic pulse train. A change in the stimulus level was introduced 400 msec after stimulus onset. Band-pass filtering (1 to 100 Hz) was used to minimize stimulus artifact. Four to six recordings of 50 sweeps were obtained for each condition, and averaged responses were analyzed in the time domain using standard peak picking procedures. RESULTS: Cortical auditory change potentials were recorded from CI users in response to both increases and decreases in stimulation level. The amplitude of the EACC was found to be dependent on the magnitude of the stimulus change. Increases in stimulus level elicited more robust EACC responses than decreases in stimulus level. Also, EACC amplitudes were significantly correlated with the slope of the growth of the onset response. CONCLUSIONS: This work describes the effect of change in stimulus level on electrically evoked auditory change potentials in CI users. The amplitude of the EACC was found to be related both to the magnitude of the stimulus change introduced and to the rate of growth of the N1-P2 onset response. To the extent that the EACC reflects processing of stimulus change, it could potentially be a valuable tool for assessing neural processing of the kinds of stimulation patterns produced by a CI. Further studies are needed, however, to determine the relationships between the EACC and psychophysical measures of intensity discrimination in CI recipients.

The electrically evoked auditory change complex: preliminary results from nucleus cochlear implant users.

OBJECTIVES: The purpose of this study was to determine if changes in the position of the stimulating electrode in the cochlea could be used to elicit the electrically evoked auditory change complex (EACC) from Nucleus cochlear implant users. DESIGN: Nine postlingually deafened adults participated in this study. Each study participant had been using his or her Nucleus CI24 cochlear implant for at least 3 mos before testing. The speech processor was bypassed and the output of the implanted receiver/stimulator was controlled directly. The stimulus was a 600 msec burst of a biphasic pulse train (1000 pps). In control conditions, the stimulating electrode was held constant and stimulation continued throughout the 600 msec recording interval. In experimental conditions, the EACC was elicited by introducing a change in the stimulating electrode 300 msec after the onset of the pulse train. The EACC was recorded using surface electrodes. Three recordings of 100 sweeps each were obtained for each stimulus condition. Bandpass filtering (1-100 Hz) was used to minimize contamination of the recordings by stimulus artifact. Averaged responses were then smoothed using a 40-msec wide boxcar filter and standard peak picking procedures were used to analyze these responses in the time domain. RESULTS: In each case, a clear onset response (P1-N1-P2) was recorded. In the experimental conditions, a second evoked potential, the EACC, was also recorded after the change in stimulating electrode. This second response had general morphological characteristics that were very similar to those of the onset response. Increasing the separation between the two stimulating electrodes in the experimental conditions resulted in a general trend toward increased EACC amplitudes. CONCLUSIONS: This report describes results of a set of experiments in which the speech processor of the cochlear implant was bypassed and the EACC was recorded in response to a change in stimulating electrode position. EACC amplitude was shown to increase as the separation between the two stimulating electrodes increased. Although preliminary in nature, these results demonstrate the feasibility of recording the EACC in response to changes in stimulating electrode position from individual cochlear implant users.