John-Martin Hempel

Objective: Robotic assistance has been introduced to improve precision and reduce intracochlear trauma during cochlear implant electrode insertion. This study evaluates the learning curve associated with robotic assistance systems and assesses objective and subjective performance metrics during early clinical implementation. Study design: Prospective observational cohort study. Setting: Tertiary referral center. Participants: Three surgeons with varying levels of experience performing robotic-assisted cochlear implantation. Interventions: Robotic-assisted cochlear implant electrode insertion after a structured training program. Main outcome measures: Robot usage time, preparation time, insertion time, total operation time, and intraoperative workload assessed using the SURG-TLX questionnaire. Learning curves were evaluated using sequential group comparisons, CUSUM analysis, and nonlinear exponential decay modelling. Model fit was compared with linear alternatives. Results: Sixty consecutive robotic-assisted insertions were analyzed. Robot usage time decreased from 19.1 minutes (cases 1–20) to 15.0 minutes (cases 41–60) ( P =0.020). Preparation time decreased from 12.5 to 9.2 minutes ( P =0.012), with the largest improvement in the first 20 cases. Exponential decay modeling demonstrated a nonlinear learning pattern with an estimated asymptotic robot usage time of 16.3 minutes (τ=1.65 procedures), outperforming linear regression based on AIC/BIC model comparison. Insertion time and total operation time did not differ significantly between groups. CUSUM analysis suggested group-level stabilization of robot usage time within 20–30 cases. SURG-TLX showed a significant reduction in situational stress between cases 21–40 and 41–60 ( P =0.031). Conclusion: Robot-assisted cochlear implant electrode insertion shows a distinct learning curve primarily driven by adjustment in robotic setup and handling. Procedural efficiency improves rapidly, with early stabilization at the individual level and later stabilization at the aggregated level over all surgeons. Structured training and protocolized workflow support safe clinical adoption.

Objective: To evaluate the audiological efficacy, patient-reported outcomes, and safety of an active middle ear implant (AMEI) in children and adults with distinct coupling options. Study design: Prospective, longitudinal, multicenter, noninterventional observational study with repeated within-subject measures and a 12-month follow-up. Setting: Nine tertiary referral centers in Germany, Austria, and Poland. Patients: Adults and children with sensorineural, conductive, or mixed hearing loss. Adults were grouped by coupling method: incus long process (LP), incus short process (SP), round window (RW), or stapes head (SH); multiple couplers were used in children. Intervention: AMEI with coupler. Main outcome measures: The primary outcome was the difference in speech recognition thresholds for 50% speech recognition (SRT50) in quiet between unaided preoperative and aided 12-month postactivation. Secondary outcomes included SRT50 in noise, sound-field thresholds, patient-reported outcomes, air- and bone-conduction thresholds, and adverse events. Results: Audiological outcomes were evaluated in 67 patients. SRT50 in quiet significantly improved across all subgroups, with large effect sizes (Cohen d _z >0.8): 17.9±9.3 dB (LP), 18.3±8.4 dB (SP), 25.3±6.3 dB (RW), 23.1±17.6 dB (SH), and 21.6±9.4 dB in children. SRT50 in noise improved by 4.3 to 9.2 dB, and functional gains ranged from 18.3 to 39.2 dB. Patients reported positive impacts on quality of life and perceived quality of hearing. Two device explantations and 2 revision surgeries occurred. Exploratory analyses showed no statistically detectable differences between coupling approaches. Conclusion: AMEI use was associated with significant audiological and patient‑reported improvements in adults and children. Within the limitations of this observational study, including limited power and baseline heterogeneity, no statistically detectable differences in outcomes were observed between coupling approaches. Coupler selection should therefore remain guided by anatomic and clinical considerations.

Purpose: Individualized cochlear implantation (CI) is essential to facilitate optimal hearing results for patients. Influence of cochlear coverage (CC) has been studied, however without consideration of different CI-categories, like single sided deafness (SSD), bimodal, and bilateral separately. Methods: Retrospective analysis of preoperative CT scans was performed at a tertiary center. For each patient their individual CC with the selected electrode array was calculated off the complete CDL. Patients were categorized into SSD (n = 30), bimodal (n = 72), and bilateral CI patients (n = 29). Speech perception within the first 12 months post-implantation was compared between patient groups with shorter and longer CC. For subgroup analysis the cutoff between a shorter or longer CC was identified by the median. Results: Cutoff between a shorter or longer CC was identified at 65% off the complete CDL for SSD and bimodal patients, and at 70% for bilateral patients. In SSD-patients longer CC was associated with better performance at activation (CC^shorter 20.0 ± 28.9% vs. CC^longer 31.5 ± 24.7%; p = 0.04) and no benefit was found with deeper insertion at 12 months. No significant benefit was found for deeper insertion in bimodal and bilateral patients. Conclusions: Capacities of hearing performance seem to differ between SSD, bimodal and bilateral patients within the first year after implantation with regards to cochlear coverage. SSD-patients appear to benefit from deeper insertion than 65% up to 12 months after implantation. However, these results should be interpreted with caution, hence development of speech perception with CI is influenced by a whole range of factors, and bimodal and bilateral treated patients are extremely heterogenous patient groups.

Mittelohrfehlbildungen sind eine heterogene Gruppe von angeborenen Anomalien mit unterschiedlichen Ätiologien, Ausprägungen und klinischen Auswirkungen. Ein gründliches Verständnis der genetischen und embryologischen Grundlagen sowie der chirurgischen Behandlungsstrategien ist für ein optimales Ergebnis entscheidend. In diesem Beitrag werden auch Indikationen sowie Vor- und Nachteile einer Hörimplantatversorgung bei solchen Fehlbildungen erläutert. Middle ear malformations (MEMs) represent a diverse group of congenital anomalies with significant implications for auditory function. These malformations, which occur in approximately 0.5 to 3% of conductive hearing loss cases, can arise from various genetic and environmental factors. They often manifest unilaterally and may occur in isolation or as part of a syndromic condition. MEMs are closely associated with abnormalities of the external ear and less frequently with inner ear anomalies. Embryologically, the middle ear develops from the first and second pharyngeal arches, with interactions between the ectoderm and endoderm contributing to the formation of essential structures such as the tympanic membrane, ossicles and Eustachian tube. Disruptions in these developmental processes can lead to a spectrum of MEMs, ranging from minor defects to severe malformations affecting multiple middle ear components. Clinical management of MEMs requires a multidisciplinary approach, involving otolaryngologists, pediatricians, and audiologists. Early intervention with appropriate hearing aids, including conventional hearing aids and bone conduction devices, is essential to mitigate the impact of conductive hearing loss on speech and language development, particularly in children. Surgical planning involves comprehensive preoperative assessment, including high-resolution computed tomography imaging to evaluate middle ear anatomy, the facial nerve course, and vascular anomalies. Traditional surgical approaches such as stapesplasty and tympanoplasty remain mainstays for correcting specific middle ear defects, while advances in technology have expanded the role of active middle ear implants in treating special cases. In conclusion, MEMs represent a heterogeneous group of congenital anomalies with diverse etiologies and clinical implications. A thorough understanding of their embryological basis, genetic underpinnings, and surgical management strategies is crucial for optimizing outcomes in affected individuals. Article published online: 04 November 2024 © 2024. Thieme. All rights reserved. Georg Thieme Verlag KG Rüdigerstraße 14, 70469 Stuttgart, Germany

Purpose: The purpose of this retrospective study is to compare the results of electrically evoked compound action potential (ECAP) measurements using automatic auditory response telemetry (AutoART) with those obtained by ART in adults. The study also aimed to evaluate the predictive value of intraoperative ART and AutoART ECAPs for speech intelligibility (SI) and hearing success (HS), and to determine if cochlear nerve (CN) cross-sectional area (CSA) obtained preoperatively by magnetic resonance imaging (MRI) scans could predict ART and AutoART ECAPs and SI and HS outcome. Methods: The study analyzed and correlated ART and AutoART ECAP thresholds at electrodes E2, E6, and E10, as well as averaged ECAP thresholds over electrodes E1–E12, using data from 32 implants. Correlations were also examined for ART and AutoART ECAP slopes. In addition, averaged ART and AutoART ECAP thresholds and slopes over all 12 electrodes for each participant were correlated with CN CSA measured from MRI sequences. SI of the monosyllabic Freiburg Speech Test at 65 dB sound pressure level was examined along with averaged ART and AutoART thresholds and slopes over all 12 electrodes. A parallel analysis was performed for HS, derived from the difference between baseline and 6-month SI. Finally, correlations between CN CSA and SI, as well as CN CSA and HS were examined. Results: The results of the study showed a significant positive correlation between ART and AutoART ECAP thresholds and as well as slopes for E2, E6, E10 and averaged thresholds and slopes of E1–E12. However, no significant correlation was observed between ART and AutoART averaged ECAP thresholds and slopes and either SI and HS or CN CSA. Furthermore, no significant correlation was found between CN CSA and SI and HS. Conclusion: While AutoART is a reliable and safe program for measuring ECAPs in adults, the study found no preoperative prognostic information on intraoperative ECAP results using parameters extracted from current MRI sequences or pre-/intraoperative information on subsequent hearing outcome using ECAP and CN CSA.

Purpose: The focus on treating patients with Menière’s Disease (MD) lies on the reduction of vertigo attacks and the preservation of sensory function. Endolympathic hydrops is considered as an epiphenomenon in MD, which can potentially be altered by endolymphatic sac surgery (ESS). Purpose of the study was to investigate the influences on vertigo control through manipulation of the perilymphatic system with or without ESS. Methods: Retrospective data analysis of 86 consecutive patients with MD according to current diagnostic criteria after endolymphatic sac surgery alone (ESS^alone; n = 45), cochlear implantation (CI) alone (CI^alone; n = 12), and ESS with CI (ESS + CI; n = 29), treated at a tertiary referral center. Main Outcome Measures: vertigo control, speech perception pre- and postoperatively. Results: Gender, side, and preoperative treatment were similar in all groups. Age was younger in the ESS^alone-group with 56.2 ± 13.0 years (CI^alone = 64.2 ± 11.4 years; ESS + CI = 63.1 ± 9.7 years). Definitive MD was present in all the CI^alone, in 79.3% of the ESS + CI and in 59.6% of the ESS^alone-patients. Likewise, vertigo control rate was 100% in the CI^alone, 89.7% in the ESS + CI and 66.0% in the ESS^alone-group. Conclusions: Vertigo control was improved in all three groups, however, superior in groups treated with CI, potentially contributed by the manipulation of both the endo- and perilymphatic systems. A more systematic characterization of the patients with larger case numbers and documentation of follow up data would be needed to evaluate a clinical effect more properly.

Purpose: In cochlear implantation, thorough preoperative planning together with measurement of the cochlear duct length (CDL) assists in choosing the correct electrode length. For measuring the CDL, different techniques have been introduced in the past century along with the then available technology. A tablet-based software offers an easy and intuitive way to visualize and analyze the anatomy of the temporal bone, its proportions and measure the CDL. Therefore, we investigated the calculation technique of the CDL via a tablet-based software on our own cohort retrospectively.Methods: One hundred and eight preoperative computed tomography scans of the temporal bone (slice thickness < 0.7 mm) of already implanted FLEX28™ and FLEXSOFT™ patients were found eligible for analysis with the OTOPLAN software. Measurements were performed by two trained investigators independently. CDL, angular insertion depth (AID), and cochlear coverage were calculated and compared between groups of electrode types, sex, sides, and age.Results: Mean CDL was 36.2 ± 1.8 mm with significant differences between sex (female: 35.8 ± 0.3 mm; male: 36.5 ± 0.2 mm;p = 0.037), but none concerning side or age. Differences in mean AID (FLEX28: 525.4 ± 46.4°; FLEXSOFT: 615.4 ± 47.6°), and cochlear coverage (FLEX28: 63.9 ± 5.6%; FLEXSOFT: 75.8 ± 4.3%) were significant (p < 0.001).Conclusion: A broad range of CDL was observed with significant larger values in male, but no significant differences concerning side or age. Almost every cochlea was measured longer than 31.0 mm. Preoperative assessment aids in prevention of complications (incomplete insertion, kinking, tipfoldover), attempt of atraumatic insertion, and addressing individual necessities (hearing preservation, cochlear malformation). The preferred AID of 720° (two turns of the cochlea) was never reached, opening the discussion for the requirement of longer CI-electrodes versus a debatable audiological benefit for the patient in his/her everyday life.

Zusammenfassung Hintergrund Angeborene schwere Mittelohrfehlbildungen, die meist einseitig auftreten, führen zu Schwerhörigkeit und ästhetischer Beeinträchtigung. Zur audiologischen Rehabilitation stehen, neben der klassischen Mittelohrchirurgie und Knochenleitungshörgeräten, aktive Mittelohrimplantate zur Verfügung. Ziel der Arbeit Es wird eine Übersicht über die audiologischen Versorgungsmöglichkeiten von Mittelohrfehlbildungen mit Fokus auf die Versorgung mit einer Vibrant Soundbridge gegeben. Material und Methoden In der Datenbank PubMed erfolgte eine selektive Literaturrecherche zu den therapeutischen Möglichkeiten bis 10/2020, außerdem wird über eigene klinische Erfahrungen berichtet. Ergebnisse Die Vibrant Soundbridge, die für Kinder ab dem 5. Lebensjahr zugelassen ist, eignet sich zur Versorgung von Mittelohrfehlbildungen ab einem Jahrsdoerfer-Score von 5. Wenngleich operativ anspruchsvoller als ein Knochenleitungshörgerät, ist die Methode sicher, liefert gute audiometrische Ergebnisse (hinsichtlich Sprachverstehen und Richtungshören den Knochenleitungsimplantaten überlegen), erfordert keine intensive postoperative Nachsorge und selten Revisionseingriffe. Die Ankopplung kann an die (rudimentär angelegte) Gehörknöchelchenkette oder am runden Fenster erfolgen. Schlussfolgerung Bei entsprechender Anatomie stellt die Vibrant Soundbridge eine geeignete Versorgungsmöglichkeit von Mittelohrfehlbildungen dar.

Despite the use of a flexible electrode, complete preservation of low frequency residual hearing can only be achieved in a minority of patients. The use of a full insertion electrode of 28 mm in patients with poor preoperative thresholds does not allow for usable additional hearing at present.