Cochlear Implant Stimulation Parameters Play a Key Role in Reducing Facial Nerve Stimulation.

A percentage (i.e., 5.6%) of Cochlear Implant (CI) users reportedly experience unwanted facial nerve stimulation (FNS). For some, the effort to control this problem results in changing stimulation parameters, thereby reducing their hearing performance. For others, the only viable solution is to deactivate the CI completely. A growing body of evidence in the form of case reports suggests that undesired FNS can be effectively addressed through re-implantation with an Oticon Medical (OM) Neuro-Zti implant. However, the root of this benefit is still unknown: is it due to surgical adjustments, such as varied array geometries and/or positioning, or does it stem from differences in stimulation parameters and/or grounding? The OM device exhibits two distinct features: (1) unique stimulation parameters, including anodic leading pulses and loudness controlled by pulse duration-not current-resulting in lower overall current amplitudes; and (2) unconventional grounding, including both passive (capacitive) discharge, which creates a pseudo-monophasic pulse shape, and a 'distributed-all-polar' (DAP) grounding scheme, which is thought to reduce current spread. Unfortunately, case reports alone cannot distinguish between surgical factors and these implant-related ones. In this paper, we present a novel follow-up study of two CI subjects who previously experienced FNS before re-implantation with Neuro-Zti implants. We used the Oticon Medical Research Platform (OMRP) to stimulate a single electrode in each subject in two ways: (1) with traditional monopolar biphasic cathodic-first pulses, and (2) with distinct OM clinical stimulation. We progressively increased the stimulation intensity until FNS occurred or the sound became excessively loud. Non-auditory/FNS sensations were observed with the traditional stimulation but not with the OM clinical one. This provides the first direct evidence demonstrating that stimulation parameters and/or grounding-not surgical factors-play a key role in mitigating FNS.

Auditory rehabilitation after temporal bone fracture with cochlear implants - a case control study.

OBJECTIVES: Temporal bone fracture can cause posttraumatic deafness. Sequelae like ossification or obliteration of the cochlea can impact the outcome of cochlear implantation. This study highlights the effect of localisation of the fracture to morphologic, electric and functional criteria. METHODS: The study group consists of patients suffering from hearing loss caused by temporal bone fracture (n = 61 ears). Patients were divided into otic capsule sparing (OCS) and otic capsule involving (OCI) fractures. The OCI group was additionally divided into subgroups with or without signs of ossification inside the cochlea. Postoperative imaging, hearing tests and electrode impedances were analysed. RESULTS: The results of postoperative hearing rehabilitation showed lower speech understanding scores for the OCI group, especially for the ossification group. OCI fractures with signs of ossification showed increased impedances. Patients in the OCI group suffered more frequently from facial nerve stimulation (FNS). FNS was most frequently observed within the ossification group. CONCLUSION: Cochlear implantation in patients with temporal bone fracture is adequate therapy for the treatment of fracture-induced deafness. In long-term observation, these patients show comparable results with regular cochlear implant (CI) patients. Implantation should be performed as soon as possible after hearing loss, before obstructing obliteration or ossification of the cochlea start.

Cochlear Implantation in Obliterated Cochlea: A Retrospective Analysis and Comparison between the IES Stiff Custom-Made Device and the Split-Array and Regular Electrodes.

Anatomical malformations, obliterations of the cochlea, or re-implantations pose particular challenges in cochlear implantation. Treatment methods rely on radiological and intraoperative findings and include incomplete insertion, the implantation of a double array, and radical cochleostomy. In addition, a stiff electrode array, e.g., the IE stiff (IES) custom-made device (CMD, MED-EL), was prescribed individually for those special cases and pre-inserted prior to facilitate cochlear implantation in challenging cases. Data on outcomes after implantation in obliterated cochleae are usually based on individual case reports since standardised procedures are lacking. A retrospective analysis was conducted to analyse our cases on obliterated cochleae treated with MED-EL devices in order to allow the different cases to be compared. Impedances and speech perception data of patients treated with the IES CMD and the double array were retrospectively compared to patients treated with a STANDARD or FLEX electrode array (the REGULAR group). Patients with a Split-Array CMD had a poor speech perception when compared to patients treated with the IES CMD device. Thus, the IES CMD can successfully be used in patients with obliterated cochleae who would otherwise be non-users, candidates for a Split-Array CMD, or candidates for partial insertion with insufficient cochlear coverage.

Advanced Bionics HiRes Ultra and Ultra 3D Series Cochlear Implant Recall: Time Course of Anomalies.

OBJECTIVES: To estimate median survival time until the appearance of anomalies indicating a potential implant failure associated with fluid ingress in implanted cochlear implant (CI) devices of the initial version of Advanced Bionics HiRes Ultra and HiRes Ultra 3D series. STUDY DESIGN: Retrospective review. METHODS: Cochlear implantation was performed in a standard fashion. Implant integrity was tested at follow-up visits by measuring impedance and electrically evoked compound action potential (ECAP). Additional tests such as electrical field imaging (EFI) were conducted by the manufacturer. Based on these tests, the presence or absence of an anomaly was classified. RESULTS: Of the 349 devices implanted at this institution, 181 showed anomalies in accordance with the special failure mode and for this reason, 120 implants were already explanted. The median survival time without anomalies was 1062 days. So far, the suspicion of device failures has been confirmed in all cases in which a post-implantation analysis was already available. CONCLUSIONS: Regular tests at the follow-up visits are necessary to monitor the integrity of CIs. LEVEL OF EVIDENCE: 3 Laryngoscope, 132:2484-2490, 2022.

ARTFit-A Quick and Reliable Tool for Performing Initial Fittings in Users of MED-EL Cochlear Implants.

This study assessed the safety and performance of ARTFit, a new tool embedded in MAESTRO, the cochlear implant (CI) system software by MED-EL GmbH (Innsbruck, Austria). ARTFit automatically measures thresholds of the electrically evoked compound action potential (ECAP) to produce initial 'maps' (ECAPMAPs), i.e., configuration settings of the audio processor that the audiologist switches to live mode and adjusts for comfortable loudness (LiveECAPMAPs). Twenty-three adult and ten pediatric users of MED-EL CIs participated. The LiveECAPMAPs were compared to behavioral maps (LiveBurstMAPs) and to the participants' everyday clinical maps (ClinMAPs). Four evaluation measures were considered: average deviations of the maximum comfortable loudness (MCL) levels of the LiveECAPMAPs and the LiveBurstMAPs from the MCLs of the ClinMAPs; correlations between the MCLs of the LiveECAPMAPs (MCLecap) and the LiveBurstMAPs (MCLburst) with the MCLs of the ClinMAPs (MCLclin); fitting durations; and speech reception thresholds (SRTs). All evaluation measures were analyzed separately in the adult and pediatric subgroups. For all evaluation measures, the deviations of the LiveECAPMAPs from the ClinMAPs were not larger than those of the LiveBurstMAPs from the ClinMAPs. The Pearson correlation between the MCLecap and the MCLclin across all channels was r2 = 0.732 (p < 0.001) in the adult and r2 = 0.616 (p < 0.001) in the pediatric subgroups. The mean fitting duration in minutes for the LiveECAPMAPs was significantly shorter than for that of the LiveBurstMAPs in both subgroups: adults took 5.70 (range 1.90-11.98) vs. 9.27 (6.83-14.72) min; children took 3.03 (1.97-4.22) vs. 7.35 (3.95-12.77). SRTs measured with the LiveECAPMAPs were non-inferior to those measured with the ClinMAPs and not statistically different to the SRTs measured with the LiveBurstMAPs. ARTFit is a safe, quick, and reliable tool for audiologists to produce ECAP-based initial fitting maps in adults and young children who are not able to provide subjective feedback.

Facial nerve stimulation in cochlear implant users - a matter of stimulus parameters?

OBJECTIVES: To describe the influence of stimulus parameters on aberrant facial nerve stimulation in cochlear implant users. METHODS: Retrospective case series (three ears - two patients). Cochlear implant patients with severe facial nerve stimulation and degraded speech comprehension who underwent re-implantation with Neuro Zti EVO (Oticon Medical). RESULTS: In all three ears, side effects evoked by aberrant facial nerve stimulation could be resolved and thereby speech comprehension was improved. CONCLUSIONS: Aberrant facial nerve stimulation in cochlear implant patients was successfully resolved by re-implantation. We hypothesize that one or more of the specific stimulus paramet ers are responsible for this success: combined common ground and monopolar stimulation mode, asymmetric pulse waveform with active anodic leading first phase followed by slow capacitive discharge, and pulse width modulation for loudness coding.

Optimized SNR-based ECAP threshold determination is comparable to the judgement of human evaluators.

In cochlear implant (CI) users, measurements of electrically evoked compound action potentials (ECAPs) prove the functionality of the neuron-electrode interface. Objective measures, e.g., the ECAP threshold, may serve as a basis for the clinical adjustment of the device for the optimal benefit of the CI user. As for many neural responses, the threshold determination often is based on the subjective assessment of the clinical specialist, whose decision-making process could be aided by autonomous computational algorithms. To that end, we extended the signal-to-noise ratio (SNR) approach for ECAP threshold determination to be applicable for FineGrain (FG) ECAP responses. The new approach takes advantage of two features: the FG stimulation paradigm with its enhanced resolution of recordings, and SNR-based ECAP threshold determination, which allows defining thresholds independently of morphology and with comparably low computational power. Pearson's correlation coefficient r between the ECAP threshold determined by five experienced evaluators and the threshold determined with the FG-SNR algorithm was in the range of r = 0.78-0.93. Between evaluators, r was in a comparable range of 0.84-0.93. A subset of the parameters of the algorithm was varied to identify the parameters with the highest potential to improve the FG-SNR formalism in the future. The two steps with the strongest influence on the agreement between the threshold estimate of the evaluators and the algorithm were the removal of undesired frequency components (denoising of the response traces) and the exact determination of the two time windows (signal and noise and noise only)."The parameters were linked to the properties of an ECAP response, indicating how to adjust the algorithm for the automatic detection of other neurophysiological responses.

First-in-human intracochlear application of human stromal cell-derived extracellular vesicles.

Extracellular vesicles (EVs) derived from the secretome of human mesenchymal stromal cells (MSC) contain numerous factors that are known to exert anti-inflammatory effects. MSC-EVs may serve as promising cell-based therapeutics for the inner ear to attenuate inflammation-based side effects from cochlear implantation which represents an unmet clinical need. In an individual treatment performed on a 'named patient basis', we intraoperatively applied allogeneic umbilical cord-derived MSC-EVs (UC-MSC-EVs) produced according to good manufacturing practice. A 55-year-old patient suffering from Menière's disease was treated with intracochlear delivery of EVs prior to the insertion of a cochlear implant. This first-in-human use of UC-MSC-EVs demonstrates the feasibility of this novel adjuvant therapeutic approach. The safety and efficacy of intracochlear EV-application to attenuate side effects of cochlea implants have to be determined in controlled clinical trials.

Correlation of Electrically Evoked Compound Action Potential Amplitude Growth Function Slope and Anamnestic Parameters in Cochlear Implant Patients-Identification of Predictors for the Neuronal Health Status.

Cochlear implants (CI) are the treatment of choice in profoundly deaf patients. Measuring the electrically evoked compound action potential (ECAP) has become an important tool for verifying the function of the spiral ganglion neurons (SGN), which are the target cells of the CI stimulation. ECAP measurement is only possible after electrode insertion. No information about the neuronal health status is available before cochlear implantation. We investigated possible correlations between the ECAP amplitude growth function (AGF) slope and anamnestic parameters to identify possible predictors for SGN health status and therefore for CI outcome. The study included patients being implanted with various electrode array lengths. Correlation analysis was performed for the mean AGF slope of the whole array, for separate electrodes as well as for grouped electrodes of the apical, medial, and basal region, with duration of deafness, age at implantation, residual hearing (grouped for electrode length), and etiology. The mean ECAP AGF slopes decreased from apical to basal. They were not correlated to the length of the electrode array or any etiology. For the mean of the full array or when grouped for the apical, middle, and basal part, the ECAP AGF slope was negatively correlated to the duration of hearing loss and the age at implantation. Since a significant negative correlation of the ECAP AGF slope and age at cochlear implantation and duration of deafness was observed, this study supports the statement that early implantation of a CI is recommended for sensorineural hearing loss. Additional factors such as the cochlear coverage and insertion angle influence the ECAP AGF slope and performance of the patient and should be included in future multifactorial analysis to study predictive parameters for the CI outcome.

Measurements of the local evoked potential from the cochlear nucleus in patients with an auditory brainstem implant and its implication to auditory perception and audio processor programming.

The measurement of the electrically evoked compound action potential (ECAP) in cochlear implant (CI) patients is widely used to provide evidence of a functioning electrode-nerve interface, to confirm proper location of the electrode array and to program the sound processor. In patients with an auditory brainstem implant (ABI), a likewise versatile measurement would be desirable. The ECAP measurement paradigm "Alternating Polarity" was utilized to record responses via the implanted ABI electrode array placed on the cochlear nucleus. Emphasizing on the different location of stimulation and recording, these responses are called local evoked potentials (LEP). LEP measurements were conducted during the clinical routine in 16 ABI patients (12 children and 4 adults), corresponding to 191 electrode contacts. A retrospective analysis of these data revealed, that LEP responses were observed in 64.9% of all measured electrode contacts. LEP responses predicted auditory perception with a sensitivity of 90.5%. False-positive rate was 33.7%. Objective LEP thresholds were highly significantly (p < 0.001) correlated both to behavioral thresholds (Pearson's r = 0.697) and behavioral most comfortable levels (r = 0.840). Therefore, LEP measurements have the potential to support fitting in ABI patients.

Hidden Electrode Failure in a Cochlear Implant User.

When the impedance of an electrode contact is highly increased in a cochlear implant, a failure of the appropriate electrode seems obvious. We present a case where impedances of some electrodes were at the lower edge of the normal range and not regarded as suspicious neither by the clinical fitting software nor by in-vivo tests conducted by the implant manufacturer. However, speech comprehension was substantially degraded and sound perception distorted. Also, on the affected electrodes, loudness perception was compromised and responses of the electrically evoked compound action potential were no longer measureable. After re-implantation, the subjective sound percept was clear again and speech comprehension scored much better than before. Later, inspection of the explant revealed shorts on the device and the implant was classified as device failure. Our case shows the importance of collecting longitudinal data of cochlear implant patients, i.e. device related technical measurements and hearing performance data, and the consideration of all these data in cases of patient complaints or suspected implant failures. Laryngoscope, 131:E1275-E1278, 2021.

Fine-grain recordings of the electrically evoked compound action potential amplitude growth function in cochlear implant recipients.

BACKGROUND: In cochlear implants (CI) measuring the electrically evoked compound action potential (ECAP) has become an important tool for verifying the electrode-nerve interface as well as establishing a basis for a map to program the speech processor. In a standard clinical setup recordings are averaged over 25-100 repetitions to allow for the detection of ECAPs within the noise floor. To obtain an amplitude growth function, these measurements are normally performed for 5-10 different stimulation levels. We evaluate a recording paradigm where the stimulation intensity is increased in quasi-continuous steps and instead of averaging repeated recordings with identical stimulation parameters, running averages over small intervals of stimulation levels are computed. The first visible nerve response was manually identified by two experts. RESULTS: Both recording paradigms were evaluated in 39 cochlear implants, showing an on average lower threshold of the first nerve response for the quasi-continuous measurement paradigm (Wilcoxon signed-rank test, p = 6.2e-08) compared to the clinical standard paradigm. The mean maximal loudness over all implants and stimulation electrodes was 13% lower at the 80 pulses/s quasi-continuous paradigm compared to the 44 pulses/s clinical standard paradigm. CONCLUSIONS: Beside a more robust determination of the ECAP threshold, the proposed quasi-continuous stimulation paradigm results in a more robust behavioral feedback of the CI user upon the maximal acceptable loudness percept. Furthermore this paradigm can also reveal the fine-structure in the amplitude growth function.

Clinical use of a system for the automated recording and analysis of electrically evoked compound action potentials (ECAPs) in cochlear implant patients.

CONCLUSION: The CustomSoundEP software can record ECAP traces in an automated manner and calculate the ECAP threshold from them. These values are in good agreement with those determined by audiologists. Manual optimization measurements, as needed when using the predecessor version 3 of the software, are done by the software itself in the newer system. OBJECTIVES: The programming of a cochlear implant speech processor is usually carried out in a subjective manner, influenced by the audiologist and the subject, and it takes considerable time. With increasing numbers of patients there is a growing need for a rapid and reliable technique to measure and analyse neural responses - one which could give suggestions for programming the speech processor and thus shorten the fitting procedure. METHODS: In 30 patients, ECAP responses were recorded postoperatively in an automated procedure. ECAP thresholds were determined automatically by the AutoNRT(TM) (Automatic Neural Response Telemetry) software and visually by seven persons. RESULTS: The time required to determine a TECAP threshold for a single electrode contact was found to be between 0.5 and 1 min.