ObjectivesCochlear implant (CI) users often face challenges with speech understanding in noisy environments, the overall naturalness of sound, and music perception due to limited access to low-frequency hearing. To address this, a “Phantom” channel was developed to enhance low-frequency sound perception. This technique is based on the current steering concept and involves stimulating the two most apical electrodes with opposite-phase signals and varying amplitudes, effectively shifting the electric field deeper into the cochlea to create a localized pitch shift. The objectives of this study were to compare various settings aimed at optimizing this virtual Phantom channel for everyday listening situations and to evaluate a potential learning effect over time.MethodsA total of 15 CI users, both unilateral and bilateral, participated in the study. The participants had a mean age of 60.0 years and an average CI usage duration of 8.1 years. The study involved adapting the CI programs through two methods: an electrical adjustment of the low-frequency channel, comparable to standard clinical adaptation, and a self-adjustment by participants for both speech comprehension and music listening using acoustic sound sample presentation. Word comprehension was assessed with the HSM sentence test under an individually set signal-to-noise ratio (SNR) with an interfering speaker, while speech intelligibility threshold (SRT) was measured using the Oldenburg sentence test (OLSA) in stationary noise. Additionally, hearing thresholds were recorded, and the CI settings were evaluated based on sound perception. The various study programs were compared to standard clinical fittings after extended adaptation phases lasting several weeks.ResultsThe hearing threshold measurements indicate that frequencies as low as 125 Hz were transmitted across the study programs. In subjective evaluations, 80% of participants strongly preferred the program with the self-adjusted low-frequency channel. Preferences varied depending on the listening situation, with participants favoring either the speech-optimized or music-optimized program accordingly. There were no significant differences in speech comprehension found between the study programs and the standard clinical program.ConclusionCochlear implant users strongly preferred the programs featuring the self-adjusted Phantom channel. This approach provided a noticeable improvement in sound perception without compromising speech comprehension.
Auditory brainstem implants (ABI) can enable hearing sensation through electrical stimulation of the cochlear nucleus. The basic stimulation and signal coding strategies of the ABI are based on those of the cochlear implant. This may not always be optimal, and ABI-specific strategies may be preferred. In a cohort of ten ABI users, we examined the feasibility of measuring local evoked potentials (LEP) via fine-grained stimulation with a forward masking paradigm. We introduce a new baseline-dependent definition of LEP amplitude for analyzing the LEP amplitude growth function to obtain threshold stimulation levels and slope values. The processing of biphasic pulses by the cochlear nucleus and the influence of the leading phase polarity were examined. There were no statistically significant differences in LEP thresholds or slopes between cathodic and anodic leading pulses. LEP thresholds measured with cathodic leading pulses (r = 0.77, t31 = 6.81, p < 0.0001) and anodic leading pulses (r = 0.70, t27 = 45.14, p < 0.0001) correlated significantly with perceptual hearing thresholds. The correlation analysis was impacted by outlier values, especially in the case of LEP thresholds measured with anodic leading pulses. Cathodic leading pulses had significantly shorter LEP peak latencies (t104.8 = 2.63, p < 0.01). These results show that the cathodic leading pulses are superior for eliciting LEPs. We suggest that cathodic leading pulses should be the basis for ABI-specific coding strategies.
IntroductionThe natural, tonotopic frequency distribution of the inner ear is typically described by the Greenwood function, which logarithmically projects the audible frequency spectrum onto the intracochlear basilar membrane. Recent developments in cochlear implant (CI) programming aim to improve sound quality and music perception through consideration of the frequency distribution as described by the Greenwood function when assigning frequency bands to the individual contacts of the electrode array. This approach is commonly referred to as anatomy-based fitting (ABF). However, empirical validation of the Greenwood function to accurately describe pitch as perceived by CI users is lacking.MethodsTwelve CI patients with single-sided deafness (SSD) participated in the study. A pitch matching task was conducted at four different appointments and with two different fitting maps (standard and ABF). At each test appointment, participants were asked to set the frequency of a pure tone presented through a loudspeaker to the pitch perceived when stimulated with the single contacts of the CI electrode array. The cochlear anatomy of the patients was reconstructed based on clinical imaging to derive the location of the stimulating contacts relative to the basilar membrane, allowing for the comparison of the pitch perceived by the patients to the frequency suggested by the Greenwood function for each stimulating contact.ResultsIn general, subjective pitch percepts were found to agree well with the frequency suggested by the Greenwood function independent of subject, contact, or applied fitting map. Differences between pitch matches and Greenwood were found to be not statistically significant. At least part of the outcomes of previous studies reporting a basal frequency shift can be explained by the tonotopic mapping functions applied within these studies.DiscussionThe present results suggest that the Greenwood function is well-suited for representing the tonotopic frequency distribution not only for normal hearing subjects but for CI recipients as well. Further advances in frequency mapping should also take the neural health of the cochlea into account, allowing for additional individualization of frequency mapping in CIs.
During cochlear implant (CI) surgery, it is desirable to perform intraoperative measurements such as Electrocochleography (ECochG) to monitor the inner ear function and thereby to support the preservation of residual hearing. However, a significant challenge arises as the recording location of intracochlear ECochG via the CI electrode changes during electrode insertion. This study aimed to investigate the relationships between intracochlear ECochG recordings, the position of the recording contact within the cochlea relative to its anatomy, and the implications for frequency and residual hearing preservation. Intraoperative ECochG recordings were conducted using the CI electrode (MED-EL) during the insertion of hearing preservation electrodes and after the insertion process. Recordings were continuously conducted using the most apical electrode (contact 1) during insertion. After insertion, the recordings were performed on all different electrode contacts. The electrode location in the cochlea during insertion was estimated using mathematical models and preoperative clinical imaging, while the postoperative electrode position was determined using postoperative clinical imaging. The study involved 10 adult CI recipients. In those with good low-frequency hearing, an increase in signal amplitude was observed, with the highest amplitudes closest to the stimulation frequency generators, and no phase change was observed. Conversely, patients with flat hearing loss exhibited a second peak with an opposite phase in the medial area of the cochlea. This study is the first to suggest that the pattern of the preoperative audiogram may influence the ECochG outcomes measured intraoperatively. Specifically, the ECochG responses during insertion appeared to behave as expected with good low-frequency hearing, while with flat hearing loss there appear to be further effects. These findings indicate that this approach can provide valuable information for the interpretation of intracochlearly recorded ECochG signals.
Einleitung Gegenwärtig steigt die Nachfrage nach App-basierten Lösungen in der Nachsorge von Cochlea Implantat (CI) Nutzern. Diese (z.B. "Remote Check" (RC), Fa. MED-EL) könnten sowohl CI-Zentren hinsichtlich der Versorgungsstruktur als auch CI-Nutzern hinsichtlich des zeitlichen Aufwands einer CI-Nachsorge spürbar entlasten. Voraussetzungen dafür sind implementierte Testmethoden, die klinisch relevante und aussagekräftige Ergebnisse liefern, um die Qualität einer dezentralisierten CI-Nachsorge nachhaltig zu sichern.
Durch die kontinuierliche Erweiterung der Indikationskriterien für den Einsatz von Cochlea-Implantaten (CI) und der mit der Implantation verbundenen lebenslangen Nachsorge steigt die Zahl der zu betreuenden Patienten kontinuierlich. Es ist absehbar, dass bei der wachsenden Zahl an CI-Patienten eine zentrale jährliche Routinekontrolle für alle Patienten auf Dauer in den Implantationszentren nicht zu leisten ist. Eine Möglichkeit, dies zu erreichen, bietet die Nachsorge mittels moderner Smartphone APPs, die Patienten in das Therapiekonzept involviert. Dieses sog. "Patient Empowerment" wird bereits bei der Therapie von Diabetes oder Herz-Kreislauf-Erkrankungen eingesetzt, und ähnlich könnte auch die CI-Nachsorge durch den Einsatz entsprechender APPs unterstützt werden. In einer im November 2022 begonnenen chronischen Machbarkeitsstudie erhalten 20 CI-Patienten mit dem Advanced Bionics Naida-M System eine Smartphone-APP, welche zur Überprüfung der Systemintegrität die Messung von Parametern wie Elektrodenimpedanzen, Mikrofonzustand oder die Hautdicke zwischen externer und interner Spule erlaubt. Darüber hinaus können Patienten Einstellungen an ihren Hörprogrammen vornehmen und diese Änderungen speichern. Ebenfalls können die Patienten einen Hörtest, etwa den Oldenburger Satztest (OlSa) im Störgeräusch, über die APP durchführen und so ihren Hörfortschritt dokumentieren. Die erhobenen Daten werden an einen zentralen Server übermittelt und sind durch das behandelnde CI-Zentrum einsehbar. 12 Patienten sind bereits in die Studie eingeschlossen worden und nutzen die Möglichkeiten zur Programmanpassung und rufen die selbst erstellten Programme in spezifischen Hörsituationen wieder auf. Aktuelle Ergebnisse und Auswertungen werden im Rahmen der Präsentation vorgestellt.
Introduction The goal of this prospective study is to safeguard remaining hearing capabilities and enhance speech outcomes through the personalized positioning of a cochlear implant (CI) electrode array. Preoperative computer tomography (CT) imaging and intraoperative ECochG monitoring determine this positioning. The study focuses on cochlear implant candidates who have pronounced hearing in the low frequency range. These individuals are implanted with a "SlimJ"-Electrode (Advanced Bionics), which is only partially inserted. This approach aims to mitigate insertion-related trauma and maintain the integrity of residual low-frequency hearing.
To preserve residual hearing during cochlear implant (CI) surgery it is desirable to use intraoperative monitoring of inner ear function (cochlear monitoring). A promising method is electrocochleography (ECochG). Within this project the relations between intracochlear ECochG recordings, position of the recording contact in the cochlea with respect to anatomy and frequency and preservation of residual hearing were investigated. The aim was to better understand the changes in ECochG signals and whether these are due to the electrode position in the cochlea or to trauma generated during insertion. During and after insertion of hearing preservation electrodes, intraoperative ECochG recordings were performed using the CI electrode (MED-EL). During insertion, the recordings were performed at discrete insertion steps on electrode contact 1. After insertion as well as postoperatively the recordings were performed at different electrode contacts. The electrode location in the cochlea during insertion was estimated by mathematical models using preoperative clinical imaging, the postoperative location was measured using postoperative clinical imaging. The recordings were analyzed from six adult CI recipients. In the four patients with good residual hearing in the low frequencies the signal amplitude rose with largest amplitudes being recorded closest to the generators of the stimulation frequency, while in both cases with severe pantonal hearing losses the amplitude initially rose and then dropped. This might be due to various reasons as discussed in the following. Our results indicate that this approach can provide valuable information for the interpretation of intracochlearly recorded ECochG signals.
OBJECTIVE:To prospectively evaluate the association between hearing preservation after cochlear implantation (CI) and intracochlear electrocochleography (ECochG) amplitude parameters. STUDY DESIGN:Multi-institutional, prospective randomized clinical trial. SETTING:Ten high-volume, tertiary care CI centers. PATIENTS:Adults (n = 87) with sensorineural hearing loss meeting CI criteria (2018-2021) with audiometric thresholds of ≤80 dB HL at 500 Hz. METHODS:Participants were randomized to CI surgery with or without audible ECochG monitoring. Electrode arrays were inserted to the full-depth marker. Hearing preservation was determined by comparing pre-CI, unaided low-frequency (125-, 250-, and 500-Hz) pure-tone average (LF-PTA) to LF-PTA at CI activation. Three ECochG amplitude parameters were analyzed: 1) insertion track patterns, 2) magnitude of ECochG amplitude change, and 3) total number of ECochG amplitude drops. RESULTS:The Type CC insertion track pattern, representing corrected drops in ECochG amplitude, was seen in 76% of cases with ECochG "on," compared with 24% of cases with ECochG "off" ( p = 0.003). The magnitude of ECochG signal drop was significantly correlated with the amount of LF-PTA change pre-CI and post-CI ( p < 0.05). The mean number of amplitude drops during electrode insertion was significantly correlated with change in LF-PTA at activation and 3 months post-CI ( p ≤ 0.01). CONCLUSIONS:ECochG amplitude parameters during CI surgery have important prognostic utility. Higher incidence of Type CC in ECochG "on" suggests that monitoring may be useful for surgeons in order to recover the ECochG signal and preventing potentially traumatic electrode-cochlear interactions.
As the indication criteria for the use of Cochlear Implants (CIs) continuously expand, along with the lifelong aftercare associated with the implantation, the number of patients requiring care is steadily increasing. It is foreseeable that with the growing number of CI patients, a central annual routine check-up for all patients at implantation centers will not be sustainable in the long run. One way to address this is through aftercare using modern smartphone apps that involve patients in the therapy concept. This so-called "Patient Empowerment" is already being used in the treatment of diabetes or cardiovascular diseases, and similarly, CI aftercare could be supported through the use of corresponding apps. In a chronic feasibility study that began in November 2022, 20 CI patients with the Advanced Bionics Naida-M system receive a smartphone app which allows the measurement of parameters such as electrode impedances, microphone status, or the skin thickness between the external and internal coil to check system integrity. Furthermore, patients can adjust settings on their hearing programs and save these changes. They can also perform a hearing test, such as the Oldenburg Sentence Test (OlSa) in noise, through the app, thereby documenting their hearing progress. The collected data are transmitted to a central server and can be accessed by the treating CI center. 12 patients have already been enrolled in the study and are using the app's capabilities for program adjustment and retrieving the self-created programs in specific hearing situations. Current results and evaluations will be presented during the presentation.
Einleitung Eine Elektrodenmigration bei Patienten mit auditorischem Hirnstammimplantat (ABI) kann – insbesondere bei Kindern – zur Ablehnung des Sprachprozessors führen. Die bildgebende Überprüfung der Elektrodenlage ist aufwändig und stellt zudem eine Strahlenbelastung dar. Für die regelmäßigen Nachsorgeuntersuchen ist die Messung des elektrisch evozierten Potenzials (LEP) (Gärtner et al. 2021, DOI: 10.1371/journal.pone.0249535) eine Alternative.
Bimodal neuromodulation is emerging as a nonsurgical treatment for tinnitus. Bimodal treatment combining sound therapy with electrical tongue stimulation using the Lenire device is evaluated in a controlled pivotal trial (TENT-A3, NCT05227365) consisting of 6-weeks of sound-only stimulation (Stage 1) followed by 6-weeks of bimodal treatment (Stage 2) with 112 participants serving as their own control. The primary endpoint compares the responder rate observed in Stage 2 versus Stage 1, where a responder exceeds 7 points in the Tinnitus Handicap Inventory. In participants with moderate or more severe tinnitus, there is a clinically superior performance of bimodal treatment (58.6%; 95% CI: 43.5%, 73.6%; p = 0.022) compared to sound therapy alone (43.2%; 95% CI: 29.7%, 57.8%), which is not observed in the full cohort across all severity groups. Consistent results are observed for the secondary endpoint based on the Tinnitus Functional Index (bimodal treatment: 45.5%; 95% CI: 31.7%, 59.9%; sound-only stimulation: 29.6%; 95% CI: 18.2%, 44.2%; p = 0.010), where a responder exceeds 13 points. There are no device related serious adverse events. These positive outcomes led to FDA De Novo approval of the Lenire device for tinnitus treatment. Bimodal neuromodulation combining sound therapy with electrical tongue stimulation using the Lenire device is a nonsurgical treatment for tinnitus. Here, the authors show the positive efficacy and safety results of a controlled one-arm pivotal trial that led to FDA De Novo approval of the Lenire device.
It is necessary to assess early language skills of children in bilingual families after bilateral implantation of cochlear implants (CI) to initiate appropriate care. The standardization group of the german Language Acquisition Test for Two-Years-Old Children (SETK 2) identified no significant differences in the comparison of the mean value of monolingual versus bilingual children, presumed, because the test requirements are simple and develop quickly in both languages. Does this also apply to children after early bilateral cochlear implantation? Retrospectively we compared the results for the subtests comprehension of words (V1) and comprehension of sentences (V2) between simultaneously bilaterally cochlear implanted multilingual children (group 1/n=20) and monolingual German children (group 2/n=94). T-value for the 114 children, each without additional disabilities and CI hearing experience greater than 12 months, was determined according to the standardization for the hearing peers. We used The Mann-Whitney test for statistical group comparison. Group 1 showed significantly lower results in word and sentence comprehension than group 2. Compared to the hearing standardization group, the median of group 1 is below average for word comprehension and well below average for sentence comprehension. Group 2 achieves comparable values on average in both tests. While monolingual German children after early bilateral implantation catch up in language comprehension, it is more difficult for children in bilingual families. We continue research to assess the development over time and increase the number of children of group 1. This analysis does not take into account the proportion of German language in the families nor the conditions of early interventions.
This study evaluated the effectiveness and usage of a smartphone application for adjusting the hearing impression of cochlear implants or hearing aids in everyday contexts. Building on previous laboratory research that demonstrated subjective auditory perception improvements through personalized settings, this research aimed to confirm these findings in real-life scenarios. Additionally, it analyzes user behavior and adaptation practices. Over a period of six months, 15 participants, including both bimodal and bilateral cochlear implant recipients, employed a self-adjustment app in their everyday lives. This application enabled them to modify the auditory experience through two distinct user interfaces and store their configurations as accessible programs. The collected data indicated that all participants were able to operate the app, and 13 of 15 participants successfully used the app throughout the whole study. In contrast to our previous findings, the acoustic environment did not affect frequency settings but did influence the choice of user interface. Bimodal users more frequently adjusted the settings for each ear independently compared to bilateral users. Most participants stated that they would also use the app outside of this study.
Einleitung Um die cochleären Strukturen zu erhalten und die bestmöglichen Ergebnisse für den Patienten mit dem CI zu erzielen, sollten eine Cochlea-Implantation so atraumatisch wie möglich sein. Flexible Elektroden ermöglichen bereits heute das Restgehör zu erhalten. Wird das aktuellen Elektrodendesign mit freisetzten Pharmazeutika versehen, kann die Immunreaktion reduziert und der Erhalt der intracochleären Strukturen unterstützt werden.
Einleitung Die Differentialdiagnose bei Schwerhörigkeit umfasst neben der Audiologie auch die Radiologie. Trotz der detaillierten Diagnostik bleibt die Ursache der individuellen Schwerhörigkeit oft unbekannt. Das bedeutet somit auch, dass eine Vorhersage bzgl. des Sprachverstehens mit dem Cochlea-Implantat schwierig ist. Genetische Diagnostik scheint auf der Basis der Entwicklung in den letzten Jahren eine neue diagnostische Option zu sein.
Introduction (background / research question) Despite decades of optimization, understanding speech with cochlear implants (CIs) remains variable, especially in complex listening scenarios. Combining electroencephalography (EEG) and positron emission tomography (PET) with O-15 water enables an objective study of neural correlates of speech perception, leveraging the high spatial resolution of the PET and the high temporal resolution of the EEG.
Introduction Obliterations of the cochlea or re-implantations pose a challenge in cochlear implant (CI) surgery. In a previous study we were able to show, that using the stiff Insertion Probe L (IP-L, MED-EL) opens the cochlea lumen and facilitates subsequent insertion of flexible CI arrays. However, post-OP impedances were increased which can be associated with an increased trauma due to this invasive intervention. Deep intracochlear application of steroids via the Inner Ear Catheter (ICAT, MED-EL) prior to CI implantation has been described to reduce implant impedances. This retrospective analysis focuses on CI recipients with obliterated cochleae who received a combined application of both devices prior to CI implantation.
Introduction The differential diagnostic to evaluate hearing impairment includes audiologic and radiologic methods. In most patient the cause is unkown. This implicates also that prediction concerning outcome is not possible. Genetic diagnostics of hearing impairment developed intensively in the last years.
In recent years, tools for early detection of irreversible trauma to the basilar membrane during hearing preservation cochlear implant (CI) surgery were established in several clinics. A link with the degree of postoperative hearing preservation in patients was investigated, but patient populations were usually small. Therefore, this study's aim was to analyze data from intraoperative extracochlear electrocochleography (ECochG) recordings for a larger group.During hearing preservation CI surgery, extracochlear recordings were made before, during, and after CI electrode insertion using a cotton wick electrode placed at the promontory. Before and after insertion, amplitudes and stimulus response thresholds were recorded at 250, 500, and 1000 Hz. During insertion, response amplitudes were recorded at one frequency and one stimulus level. Data from 121 patient ears were analyzed.The key benefit of extracochlear recordings is that they can be performed before, during, and after CI electrode insertion. However, extracochlear ECochG threshold changes before and after CI insertion were relatively small and did not independently correlate well with hearing preservation, although at 250 Hz they added some significant information. Some tendencies-although no significant relationships-were detected between amplitude behavior and hearing preservation. Rising amplitudes seem favorable and falling amplitudes disadvantageous, but constant amplitudes do not appear to allow stringent predictions.Extracochlear ECochG measurements seem to only partially realize expected benefits. The questions now are: do gains justify the effort, and do other procedures or possible combinations lead to greater benefits for patients?