Normative findings of electrically evoked compound action potential measurements using the neural response telemetry of the Nucleus CI24M cochlear implant system

One hundred and forty-seven adult recipients of the Nucleus 24 cochlear implant system, from 13 different European countries, were tested using neural response telemetry to measure the electrically evoked compound action potential (ECAP), according to a standardised postoperative measurement procedure. Recordings were obtained in 96% of these subjects with this standardised procedure. The group results are presented in terms of peak amplitude and latency, slope of the amplitude growth function and ECAP threshold. The effects of aetiological factors and the duration of deafness on the ECAP were also studied. While large intersubject variability and intrasubject variability (across electrodes) were found, results fell within a consistent pattern and a normative range of peak amplitudes and latencies was established. The aetiological factors had little effect on the ECAP characteristics. However, age affected ECAP amplitude and slope of the amplitude growth function significantly; i.e., the amplitude is higher in the lowest age category (15-30 years). Principal component analysis of the ECAP thresholds shows that the thresholds across 5 electrodes can be described by two factors accounting for 92% of the total variance. The two factors represent the overall level of the threshold profiles ('shift') and their slopes across the electrode array ('tilt'). Correlation between these two factors and the same factors describing the T- and C-levels appeared to be moderate, in the range of 0.5-0.6.     

Summary of results using the nucleus CI24M implant to record the electrically evoked compound action potential

OBJECTIVE: This study outlines a series of experiments using the neural response telemetry (NRT) system of the Nucleus CI24M cochlear implant to measure the electrically evoked compound action potential (EAP). The goal of this investigation was to develop a protocol that allows successful recording of the EAP in a majority of CI24M cochlear implant users. DESIGN: Twenty-six postlingually deafened adults participated in this study. A series of experiments were conducted that allowed us to examine how manipulation of stimulation and recording parameters may affect the morphology of the EAP recorded using the Nucleus NRT system. RESULTS: Results of this study show consistent responses on at least some electrodes from all subjects. Cross-subject and cross electrode variations in both the growth of the response and the temporal refractory properties of the response were observed. The range of stimulus and recording parameters that can be used to record the EAP with the Nucleus NRT system is described. CONCLUSIONS: Using the protocol outlined in this study, it is possible to reliably record EAP responses from most subjects and for most electrodes in Nucleus CI24M cochlear implant users. These responses are robust and recording these responses does not require that the subject sleep or remain still. Based on these results, a specific protocol is proposed for measurement of the EAP using the NRT system of the CI24M cochlear implant. Potential clinical implications of these results are discussed.     

Speech perception in nucleus CI24M cochlear implant users with processor settings based on electrically evoked compound action potential thresholds

Adjusting the speech processor of a cochlear implant, per electrode, to the individual's response is a laborious task that may interfere with a user-friendly start of implant-mediated hearing, particularly in children. This research concerns the possibility of processor adjustment based on a profile derived from measurements of the electrically evoked compound action potential (ECAP) thresholds across the electrode array, followed by adjustment of the overall level of the profile to the hearing threshold and maximum comfortable loudness level using live voice. The results for CVC word lists show that speech perception is quite insensitive to the threshold setting of the speech processor. On average, the speech score does not decrease by more than 10% when, with the new method, the threshold setting comes out so much lower that the dynamic range has doubled. In contrast, the speech score appears to be sensitive to an increase of the maximum high-frequency stimulation settings for the basal electrodes, resulting in lower scores at these higher settings. The correlation between the overall ECAP thresholds and conventionally measured subjective thresholds is weak (r = 0.64). However, the correlation between the slopes of these threshold curves is satisfactory (r = 0.82). The correlation between the ECAP thresholds and the maximum stimulation levels is poor, both with respect to overall level and slope (r = 0.39 and 0.36, respectively). Applicability of the ECAP threshold in processor adjustment could not be demonstrated in this study. Prediction of the most critical factor in speech perception, the slope of the maximum stimulation curve, from the ECAP thresholds is poor. However, considering habituation to the initial processor setting of at least 6 months, the small decrease in the CVC scores with the new setting suggests that a more user-friendly adjustment procedure can be developed.     

Comparison of electrically evoked whole-nerve action potential and electrically evoked auditory brainstem response thresholds in nucleus CI24R cochlear implant recipients

In this study, differences between electrically evoked whole-nerve action potential (EAP) and electrically evoked auditory brainstem response (EABR) measurements within Nucleus CI24R cochlear implant recipients were evaluated. Precurved modiolus-hugging internal electrode arrays, such as the CI24R, are designed to provide more direct stimulation of neural elements of the modiolus. If the electrode array is closer to the modiolus, electrically evoked and behavioral levels might be lower than were previously recorded for the straight electrode array, the CI24M. EAP and EABR growth functions and behavioral levels were obtained for 10 postlingually deafened adults. Results revealed no significant differences between EAP and EABR threshold levels, and these levels were not significantly lower than those obtained using the CI24M.     

Adaptation of the electrically evoked compound action potential (ECAP) recorded from nucleus CI24 cochlear implant users

OBJECTIVE: This study had three main goals. The first goal was to assess the extent to which neural adaptation varied across cochlear implant users. The second goal was to determine whether adaptation at the level of the auditory nerve was correlated with word recognition ability. The third goal was to determine whether peripheral neural adaptation had an impact on the relationship between the electrically evoked compound action potential (ECAP) thresholds and MAP levels. DESIGN: Neural response telemetry software was used to record the ECAP in 21 Nucleus cochlear implant users. A series of 110 ECAP recordings were made over a 5-min period at three different stimulation rates: 15, 80, and 300 Hz. The stimulation levels used to record this series of responses were held constant at or near the level the subject identified as his or her maximum comfort level (C-level) for the 300-Hz stimulation rate. Consistent decreases in ECAP amplitude as measured from the beginning to the end of the 5-min stimulation interval were interpreted as evidence of neural adaptation. Regression analysis procedures were then used to assess the relationship between neural adaptation and word recognition. RESULTS: Significant levels of adaptation were observed for all 21 subjects at stimulation rates of 80 and 300 Hz. Little or no adaptation was observed over the 5-min recording period when the 15-Hz rate was used. The amount of adaptation was greatest at the 300-Hz rate and varied substantially across cochlear implant users. No relationship between the amount of adaptation and word recognition was found. Neither was the degree of adaptation shown to influence the relationship between ECAP thresholds recorded at low rates and the levels used to program the speech processor. CONCLUSIONS: Cochlear implant users experienced varying degrees of long-term adaptation in response to continuous electrical stimulation. The effects of adaptation on the ECAP were apparent even at stimulation rates as low as 80 Hz. Although variations in the amount of adaptation are likely to reflect cross-subject differences in the status of the auditory nerve, no predictable relationship was found between these physiologic measures of peripheral neural function and either word recognition or the relationship between ECAP thresholds and MAP levels.     

神经反应遥测技术在人工耳蜗植入术中的监测应用

目的探讨在人工耳蜗植入术中能快速、准确地判断人工耳蜗装置的完好性和患者客观听觉反应的监测方法.方法在40例患儿人工耳蜗植入术中先测定电极阻抗,然后使用神经反应遥测技术(neuralresponsetelemetry,NRT)监测6个电极的电诱发听神经复合动作电位(electricallyevokedauditorynervecompoundactionpotentials,ECAP).结果患儿所有电极阻抗正常,ECAP的检出率分别为97.5%(39例/40例)和92.1%(221个电极/240个电极).其中33例内耳无畸形的患儿所有198个测试电极中有195个电极测出清晰的ECAP波形(98.5%).7例内耳Mondini畸形患者共42个测试电极中有26个电极测得ECAP波形(61.9%),两组之间差异有极显著性.靠近耳蜗底回(高频区)的电极比靠近蜗尖(低频区)的电极具有较高的ECAP反应阈值和较高的ECAP饱和阈值.结论NRT技术可以简便、快速和准确地判断患者的听神经反应,可望成为术中常规监测方法,内耳Mondini畸形是影响ECAP检出的重要因素.     

Neural response telemetry with the nucleus CI24M cochlear implant

OBJECTIVES: To review our intraoperative and postoperative testing protocol for cochlear implant patients. This study describes the methodologies and applications of a new technique called neural response telemetry (NRT) for the Nucleus CI24M cochlear implant system. NRT uses radiofrequency telemetry technology to measure the action potentials of the auditory nerve. STUDY DESIGN: We have developed a specific protocol for intraoperative testing of the implant device before, during, and after implantation. This includes device integrity tests, visual detection of electrical stapedius muscle reflexes (VESR), and NRT. METHODS: Our methodologies use the commercial software (Windows-based Diagnostic and Programming System [WIN-DPS] and NRT) for the Nucleus CI24M. We describe the details of our protocol used on all of the patients (14 adults and 14 children) who received CI24M implants at Mayo Clinic (Rochester, MN). Our protocol correlates the NRT threshold with the behavioral responses for each patient on at least four electrodes. RESULTS: From August 1, 1998, to December 31,1998, we completed electrode integrity tests, NRT, and VESR testing intraoperatively on 12 patients with the Nucleus CI24M. We have measured normal implant function on all 28 of our CI24M patients with one exception. One of our children had a device failure after approximately 4 months as a result of head trauma. We have also obtained NRT results from an additional 10 patients postoperatively. CONCLUSIONS: The measurement of device and electrode array function is quite simple with the CI24M software. These measurements can be obtained intraoperatively as well as postoperatively. We conclude that VESR and NRT measurements can be very helpful in programming for patients with cochlear implants, especially children, because they provides us with target settings for the speech processor.     

神经反应遥测技术在人工耳蜗植入术中的监测应用

目的：探讨在人工耳蜗植入术中能快速,准确地判断人工蜗装置的完好性和患者客观听觉反应的监测方法。方法：在40例患儿人工耳蜗植入术中先测定电极阻抗,然后使用神经反应遥测技术（neural response telemetry,NRT)监测6个电极的电诱发听神经复合动作电位（electrically evoked auditory nerve compound action potentials,ECAP)。结果：患儿所有电极阻抗正常,ECAP的检出率分别为97．5％（39例／40例）和92．1％（221个电极／240个电极）,其中33例内耳无畸形的患儿所有198个测试电极中有195个电极测出清晰的ECAP波形（98．5％）,7例内耳Mondini畸形患者共42个测试电极中有26个电极测得ECAP波形（61．9％）,两组之间差异有极显著性,靠近耳蜗底回（高频区）的电极比靠近蜗尖（低频区）的电极具有较高的ECAP反应阈值的ECAP饱和阈值。结论：NRT技术可以简便,快速和准确地判断患者的听神经反应,可望成为术中常规监测方法。内耳Mondini畸形是影响ECAP检出的重要因素。     

Channel interaction in cochlear implant users evaluated using the electrically evoked compound action potential

One likely determinant of performance with a cochlear implant is the degree of interaction that occurs when overlapping subsets of nerve fibers are stimulated by various electrodes of a multielectrode array. The electrically evoked compound action potential (ECAP) can be used to assess physiological channel interaction. This paper describes results from two different methods of analysis of ECAP channel interaction measures made by the Nucleus neural response telemetry system. Using a forward-masking stimulus paradigm, masker and probe pulses are delivered through different electrodes. The response to the probe is then dependent on the extent of overlap in the stimulated neural populations. The amplitude of response to the probe as a function of masker electrode position then reflects the degree of overlap between the population of neurons responding to the masker and those stimulated by the probe. Results demonstrate large variations across individual implant users as well as across electrodes within an individual. In general, the degree of interaction is shown to be dependent on stimulus level.     

Intra-operative recordings of electrically evoked auditory nerve action potentials in young children by use of neural response telemetry with the nucleus C124M cochlear implant.

The electrically evoked action potential (EAP) was recorded intra-operatively by use of neural response telemetry (NRT) on the Nucleus C124M cochlear implant. The aim of the present study was to investigate the EAP in young children immediately following implant surgery and whilst the children were still anaesthetized. The effect of data collection parameters on the reliability of the EAP was assessed and the relationships of the EAP findings to the intra-operative electrical auditory brainstem response (EABR) and early behavioural threshold levels (T-levels) were also investigated. The study data comprised intra-operative recordings in 60 children. Age at implantation was less than five years in 42 (70%) of the children. Aetiology of deafness was congenital in the majority of children (55, 92%), meningitic in four children and of unknown origin in one child. Optimum test parameters for the intra-operative EAP were an amplifier gain of 40 dB and a delay of 50 micros in order to minimize the effects of amplifier saturation due to stimulus artefact and to maximize the identification of the N1 component. An intra-operative protocol was established which involved recording four stimulus levels on each of the 22 electrodes of the electrode array, the range of stimulus levels being tailored towards the expected EAP thresholds and T-levels so as to identify response threshold. There was significant correlation between the intraoperative EAP thresholds and the early T-levels (Pearson's r = 0.93 ;p<0.01) when a correction factor was introduced based on a reliable behavioural measure of the threshold of electrical stimulation on electrode 10. The intra-operative EAP threshold, when combined with a limited amount of behavioural data, may therefore be used to predict the T-level with a useful degree of accuracy. This result is also supported by the significant correlation observed between the intra-operative thresholds of the EAP and EABR.     

An introduction to the biophysics of the electrically evoked compound action potential

A computational model of the electrically evoked compound action potential (ECAP) has been developed. In addition to being a useful research tool, it serves as an excellent introduction to the basic biophysics of ECAP recording techniques. ECAPs are modeled as a sum of single-fiber action potentials (SFAPs) in response to an electrical stimulus. Each SFAP is calculated from the potential induced at the recording site by the membrane currents arising on an axon as a spike propagates along it. The factors that alter SFAP and ECAP morphology and latency are discussed, as are the mechanisms of stimulus artefact and the advantages and limitations of different artefact-suppression techniques. The assumptions of the model are presented, as are potential ways of improving the physiologic data available from clinical recordings. Potential applications of this technology in the investigation of the biophysical mechanisms of the implanted cochlea are suggested.     

A new method for dealing with the stimulus artefact in electrically evoked compound action potential measurements

OBJECTIVE: Residual charge on recording electrodes leads to elevated potentials after the end of the stimulus, which can easily overload the electrically evoked compound action potential (eCAP) recording systems (neural response imaging or neural response telemetry). A new method for dealing with this problem was tested in a series of animal experiments. MATERIAL AND METHODS: We developed an amplifier with a compensation circuit that reduces the effect of the residual charge by electrical subtraction at the input. Using this amplifier we compared different artefact rejection protocols simultaneously in chronically implanted guinea pigs. A new, systematic nomenclature for the various forward masking schemes, based on the number of frames involved, is proposed. RESULTS: Proper adjustment of the compensation circuit reduces the overload time from > 200 micros to < 30 micros, but the compensation signals influence the final output signal considerably. To eliminate this deliberately introduced, reproducible artefact, an additional artefact rejection scheme is necessary. With alternating polarity (AP) and forward masking paradigms we could reliably record the N1 peak. Forward masking responses reveal shorter latencies for cathodic-first biphasic stimuli than for anodic-first pulses. The average of these two closely resembles the response obtained with the AP paradigm. CONCLUSIONS: It is worthwhile implementing the electrical compensation method proposed herein in clinical neural response imaging or neural response telemetry systems, as it represents a more robust way of assessing the eCAP.     

A simple two-component model of the electrically evoked compound action potential in the human cochlea

Neural response telemetry (NRT) permits in situ intracochlear recordings of the electrically evoked compound action potential from the auditory nerves using scala tympani electrodes. The recorded NRT waveforms can generally be categorized under either single positive peak or double positive peak waveforms. This is similar to the observations from Stypulkowski and van den Honert, who suggested that the double peak complex arises from two components that could be axonal and dendritic in origin, respectively. Using a simple mathematical model which linearly combines two separate waveforms similar in shape but differing in amplitude and latencies, it was possible to simulate the various NRT waveform categories. The simulation results support the view that the two waveform components originate from dendritic or axonal processes and implies that the shape of the response waveform may provide information about the degree of neural survival in the stimulated cochlea. This information could be useful for determining optimal speech coding parameters for cochlear implant users on an individual basis.     

A longitudinal study of electrode impedance, the electrically evoked compound action potential, and behavioral measures in nucleus 24 cochlear implant users.

OBJECTIVE: The primary goal of this study was to examine changes that may occur in electrode impedance, electrically evoked compound action potential (EAP) threshold and slope of the EAP growth function, and behavioral measures of threshold T-level) and maximum comfort (C-level) over time in both adult and child cochlear implant users. Secondary goals were to determine whether changes in these measures are consistent between children and adults, and to determine whether behavioral measures (MAP T- and C-levels) and electrophysiologic measures (EAP thresholds) exhibit the same trends over time. DESIGN: Thirty-five children and 33 adults implanted with the Nucleus CI24M between November 1996 and August 1999 participated in this study. Subjects were included in this study if 1) they had used their implant for at least 1 yr after device connection, and 2) they had participated in the necessary data collection at a minimum number of the time intervals assessed in this study. EAP threshold, slope of the EAP growth function, and common ground electrode impedance measures were collected intraoperatively, at initial stimulation, and at several subsequent visits up to 2 yr post initial stimulation. MAP T- an d C-levels weremeasured at initial stimulation and at the same time intervals as described above. RESULTS: Changes in electrode impedance, EAP thresholds, and slope of the EAP growth function from measures made intraoperatively, at initial stimulation, and at 1 to 2 mo post initial stimulation were similar in both children and adults. Beyond the 1- to 2-mo visit, children exhibited significant increases in electrode impedance, EAP thresholds, slope, and MAP T-levels, whereas these samemeasures in adults remained relatively stable. EAP thresholds in children stabilized by the 3- to 8-mo visit, and electrode impedance stabilized by the 6- to 8-mo visit, while slope of the EAP growth function, MAP T-levels,and MAP C-levels werestable by 1 yr post initial stimulation. C-levels in adults increased up to 1 yr post initial stimulation; however, the amount of increase was much smaller than that seen in children. In both children and adults, longitudinal trends in EAP thresholds mirrored T-level more closely than C-level. CONCLUSIONS: The results of this study suggest that peripheral changes occur in many children that do not generally occur in adults within the first year of cochlear implant use. One implication of these results is that if EAP thresholds are to be used to assist in programming the speech processor for children, it is best to make those measures at the same time interval as device programming rather than using measures made intraoperatively or at the initial programming session to set MAP levels at later visits.     

Use of neural response telemetry measures to objectively set the comfort levels in the Nucleus 24 cochlear implant

Cochlear implant programming necessitates accurate setting of programming levels, including maximum stimulation levels, of all active electrodes. Frequently, clinical techniques are adequate for setting these levels; however, they are sometimes insufficient (e.g., very young children). In the Nucleus 24, several methods have been suggested for estimation of comfort levels (C levels) from neural response telemetry (NRT); however, many require co-application of clinical measurements. Data was obtained from 21 adult Nucleus 24 recipients to develop reliable predictions of C levels. Multiple regression analysis was performed on NRT threshold, slope of the NRT growth function, age, length of deafness, length of cochlear implant use and electrode impedance to examine predictive ability. Only the NRT threshold and slope of the growth function measures were significant predictors yielding R2 values from 0.391 to 0.769. Results demonstrated that these measures may provide an alternative means of estimating C levels when other clinical measures are unavailable.     

Estimation of surviving spiral ganglion cells in the deaf rat using the electrically evoked auditory brainstem response

A procedure was developed to record the electrically evoked auditory brainstem response (EABR) in the rat with sufficiently little stimulus artifact to permit systematic measurements of the first positive wave (P1), the compound action potential (CAP) of the auditory nerve. Our principal aim was to verify the theoretical prediction that maximum P1 amplitude is directly proportional to the number of excitable auditory nerve fibers. This was carried out in animals with graded lesions of the spiral ganglion induced by perfusion of the cochlea with different concentrations of neomycin. Two series of observations confirmed the theoretical prediction. Several measures of P1, including maximum amplitude, and slopes of the P1 and P1-N1 growth functions, were highly correlated with the number of surviving spiral ganglion cells. Correlation coefficients (r) ranged from 0.75 to 0.92. Amplitudes of the later waves exhibited much lower correlations with spiral ganglion cell counts. These findings suggest that measurement of the CAP in deaf humans, possibly as wave I of the EABR, should provide quantitative information about the status of the nerve, which could be useful in screening candidates for cochlear implants, prescribing the optimum device for individual patients, and determining how benefits derived from such devices relate to the condition of the auditory nerve.     

Acoustic-electric interactions in the guinea pig auditory nerve: simultaneous and forward masking of the electrically evoked compound action potential

The study investigated the time course of the effects of acoustic and electric stimulation on the electrically evoked compound action potential (ECAP). Adult guinea pigs were used in acute experimental sessions. Bursts of acoustic noise and high-rate (5000 pulses/s) electric pulse trains were used as maskers. Biphasic electric pulses were used as probes. ECAPs were recorded from the auditory nerve trunk. Simultaneous masking of the ECAP with acoustic noise featured an onset effect and a decrease in the amount of masking to a steady state. It was characterized by a two-component exponential function. The amount of masking increased with masker level and decreased with probe level. Post-stimulatory ECAP recovery often featured a non-monotonic time course, described by a three-component exponent. Electric maskers produced similar post-stimulatory effects in hearing and acutely deafened subjects. Acoustic stimulation affects the ECAP in a level- and time-dependent manner. Simultaneous masking follows a time course comparable to that of adaptation to an acoustic stimulus. Refractoriness, spontaneous activity, and adaptation are suggested to play a role in ECAP recovery. Post-stimulatory changes in synchrony, possibly due to recovery of spontaneous activity and an additional hair-cell independent mechanism, are hypothesized to contribute to the observed non-monotonicity of recovery.     

Estimation of surviving spiral ganglion cells in the deaf rat using the electrically evoked auditory brainstem response

A procedure was developed to record the electrically evoked auditory brainstem response (EABR) in the rat with sufficiently little stimulus artifact to permit systematic measurements of the first positive wave (P1), the compound action potential (CAP) of the auditory nerve. Our principal aim was to verify the theoretical prediction that maximum P1 amplitude is directly proportional to the number of excitable auditory nerve fibers. This was carried out in animals with graded lesions of the spiral ganglion induced by perfusion of the cochlea with different concentrations of neomycin. Two series of observations confirmed the theoretical prediction. Several measures of P1, including maximum amplitude, and slopes of the P1 and P1-N1 growth functions, were highly correlated with the number of surviving spiral ganglion cells. Correlation coefficients (r) ranged from 0.75 to 0.92. Amplitudes of the later waves exhibited much lower correlations with spiral ganglion cell counts. These findings suggest that measurement of the CAP in deaf humans, possibly as wave I of the EABR, should provide quantitative information about the status of the nerve, which could be useful in screening candidates for cochlear implants, prescribing the optimum device for individual patients, and determining how benefits derived from such devices relate to the condition of the auditory nerve.