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 dz>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.

Bone surgery on the skull generates substantial structure-borne noise, which can lead to temporary or permanent hearing threshold shifts in patients due to transmission through bone and air conduction. This study investigates the relationship between drilling parameters and resulting noise exposure during cranial bone drilling. To minimize variability and improve reproducibility, all tests were conducted by a single surgeon using both bone substitute material and human donor specimens. Accelerometers and dynamic force sensors were employed to capture vibration and contact force data. The experimental setup successfully correlated acceleration and force signals with airborne sound, enabling insights into patient-experienced noise. Surprisingly, the variability of measurement results in synthetic bone material was comparable to that in human samples, highlighting its practicality but also its limitations. Bone density showed no significant influence on noise levels in cortical bone. Approximately one-third of drilling noise variance could be explained by controllable parameters - drill speed, diameter, and applied force - each contributing nearly equally. Cortical bone samples enabled clearer differentiation of factors due to repeated measurements. All tests were performed without irrigation to isolate drilling noise. Results underscore the potential for integrating real-time sensor feedback into surgical tools to monitor and reduce intraoperative noise exposure. Future work will focus on further standardization using robot-assisted drilling and expanding tests to spongy and aerated bone structures.

Abstract Background The Chronic Otitis Media Questionnaire-12 (COMQ-12) is a disease-specific health-related quality of life (HRQoL) instrument originally developed in English for patients with chronic otitis media (COM). This study aimed to translate the COMQ-12 into German and to validate the resulting German version, and assess its psychometric properties. Methods The COMQ-12 underwent forward–backward translation into German. Seventy-nine patients with COM who underwent middle ear surgery were prospectively enrolled. HRQoL was assessed preoperatively and 6 months postoperatively via the German COMQ-12. Additionally, pure tone audiometry was performed at both time points. Psychometric properties, including internal consistency, test–retest reliability, discriminant validity, agreement validity, responsiveness, and response shift, were evaluated. Results The German COMQ-12 demonstrated high internal consistency both preoperatively (Cronbach’s α = 0.87) and postoperatively (Cronbach’s α = 0.84). The test–retest reliability was high (r = 0.89). It significantly discriminated between COM patients and healthy controls (p < 0.001) and showed strong convergent validity with a global health-specific question (r = 0.64, p < 0.001). The questionnaire exhibited high responsiveness (standardized response mean = -0.80) with minimal response shift effects (effect size = 0.30). The correlations with the audiometric parameters were weak (r = 0.11–0.16). Conclusions The German version of the COMQ-12 has satisfactory psychometric properties and can be recommended for assessing HRQoL in German-speaking population with COM. Its suitability for evaluating symptom-related quality of life is due to its symptom-focused design and high level of responsiveness. Its low response shift also makes it ideal for longitudinal monitoring of treatment outcomes.

BACKGROUND:The European Board Examination in Otorhinolaryngology, Head and Neck Surgery (EBEORL-HNS) is a Europe-wide specialty examination consisting of a written multiple-choice test and a standardized oral examination. Only limited psychometric analyses have been published to date. OBJECTIVE:This study aimed to evaluate examination data from recent years and assess the formats regarding difficulty, reliability, and pass rates. MATERIALS AND METHODS:Aggregated data from 2013-2024 were analyzed. Mean scores, standard deviations, item difficulty, item discrimination, Cronbach's alpha, and Angoff's score were calculated. The written and oral parts were examined descriptively and comparatively. RESULTS:The written examination demonstrated a mean difficulty of 67% (proportion of correctly answered items), a pass rate of 82%, and Cronbach's alpha of 0.83 (internal consistency). The passing cutoff (according to the Angoff method) was 59 points on average. The oral part showed a mean difficulty of 70%, a pass rate of 74%, and an average score of around 3.0 on a four-point scale. Year-to-year variability largely reflected differences in the international candidate cohorts. CONCLUSION:The findings confirm that the EBEORL-HNS demonstrates stable psychometric quality. Compared to national specialty examinations, it offers high transparency and clearly defined quality criteria. Variations in performance appear more related to heterogeneous training backgrounds than to shortcomings of the assessment tools.

BACKGROUND:Fully implantable active middle ear implants require implantable sensors to replace external microphones. A recently proposed piezoelectric sensor for ossicular coupling is promising, but data on anatomical feasibility and the impact of coupling mechanics on sensor performance and feedback are limited. OBJECTIVE:To assess the anatomical feasibility of ossicular coupling sites and evaluate sensor sensitivity and feedback for alternative coupling strategies using a piezoelectric sensor. METHODS:Ear morphology was assessed in a retrospective, single center analysis of 101 ears from 99 patients undergoing Vibrant Soundbridge implantation. Temporal bone experiments (n = 26) yielded comparative measurements of sensor sensitivity and Floating Mass Transducer (FMT)-induced feedback for a piezoelectric sensor prototype coupled at the umbo and incudostapedial joint. In umbo coupling, the sensor was braced against the promontory using custom-made spacers. RESULTS:The umbo was feasible in 71 % of ears, whereas an intact incudostapedial joint was present in 30 %, mainly due to prior surgery. In temporal bones with intact ossicular chains, umbo coupling showed sensitivity comparable to incudostapedial coupling, with most deviations within ±10 dB across 0.5-4 kHz. Spacer stiffness and contact force influenced sensitivity, with low pretension (∼10 mN) yielding the most stable responses. FMT-induced feedback at the umbo was comparable to or lower than incudostapedial coupling. CONCLUSION:The umbo is a feasible and robust coupling site for implantable piezoelectric sensors. Spacer-mediated coupling accommodates anatomical variability while maintaining sensitivity and favorable feedback, supporting its use as an alternative to incudostapedial joint placement.

Abstract This study analyzes the histomorphology of human stapes footplates, focusing on the footplate (FP), to enhance reconstructive otosurgery. Seven human stapes specimens obtained during pathological dissections were histologically processed. Tissue layer thicknesses (bone and cartilage) were measured at five points in longitudinal sections and three points in cross sections. Additional analyses of surrounding tissue area up to 100 μm from each point were conducted. A total of 1400 individual measurements were included in the analysis of the human FP, comprising 350 measurements each for cartilage and bone layer thickness, as well as the determined cartilage and bone areas. The FP consisted of a flat epithelial layer, a bone layer facing the tympanic cavity, and a cartilage layer. The central total thickness was 118.06 μm, increasing by 36% toward the periphery. Bone composition was 40% centrally and larger peripherally at 56%. Cross sections showed more homogeneous distribution, with a total thickness of 73.44 μm and 42% bone. This first detailed qualitative and quantitative topographical tissue analysis of the FP confirms a bilayered bone-cartilage structure with increasing bone thickness toward the periphery. The findings provide critical insights into prosthetic coupling sites and support the development of optimized reconstructive strategies in middle ear surgery.

The aim of this study was to evaluate the feasibility of a 3D exoscope system (VITOM 3D, Karl Storz, Tuttlingen, Germany) in comparison with conventional surgical microscopes (SM, hereafter referred to as ‘microscope’) in ear surgery. This paper represents the second part of a two-part publication series. A total of 62 patients were included in the study, with 31 cases assigned to the exoscope group (E+) and 31 to the conventional microscope group (E–). Surgical procedures comprised cochlear implantation (nE+ = 10, nE– = 10), reconstructive middle ear surgery for chronic otitis media with cholesteatoma (COMwC; nE+ = 11, nE– = 11), and without cholesteatoma (COMsC; nE+ = 10, nE– = 10). While the first part of the study focused on objective perioperative parameters, the present part specifically evaluates subjective outcomes as reported by the operating surgeons. These include technical aspects (perceived image quality assessed through a detailed questionnaire), surgical aspects (handling characteristics, mental and physical workload evaluated using the NASA-TLX questionnaire and ergonomic factors assessed using a questionnaire to assess localized musculoskeletal discomfort (LMD)), as well as overall satisfaction. All assessments were completed immediately after each procedure using standardized questionnaires. Additionally, a cluster analysis was performed to identify potential differences between the subgroups. The microscope received significantly better scores regarding image quality. The exoscope achieved comparable ratings for body posture and ergonomic comfort, while handling was rated slightly inferior. NASA-TLX assessments revealed no significant differences in mental or physical workload between the systems. LMD scores indicated overall low musculoskeletal strain, with only the upper back showing slightly higher discomfort in the exoscope group. Cluster analysis demonstrated heterogeneous subgroup patterns without a consistent trend, although cochlear implantation procedures were most frequently associated with less favorable subjective ratings in the exoscope group. Direct comparison of both visualization systems confirmed a slight but significant advantage of the surgical microscope in terms of system operation, visual display, and handling, while ergonomics showed no significant difference Under the conditions evaluated in this study, the investigated exoscope system did not achieve equivalence to a standard microscope across all assessed domains. In particular, limitations in optical performance and handling currently preclude its use as a full substitute for the microscope in routine ear surgery. The present findings apply to the specific system generation evaluated and the study conditions employed. Ongoing technological advancements and further refinement of exoscope systems may enable future generations to achieve equivalence with microscopes and serve as viable alternatives in routine clinical practice Our study involves a clinical trial registered at the ethics committee of the Carl Gustav Carus Faculty of Medicine at the Technische Universität Dresden, with the registration number EK 393102018. This registration reflects our commitment to transparency and adherence to international standards for clinical research.

Die European Board Examination in Otorhinolaryngology – Head and Neck Surgery (EBEORL-HNS) stellt eine europaweit durchgeführte Facharztprüfung dar. Sie umfasst einen schriftlichen Multiple-Choice-Test und eine standardisierte mündliche Prüfung. Bisher liegen nur wenige Analysen zur psychometrischen Qualität dieser Prüfung vor. Ziel war es, die Prüfungsdaten der letzten Jahre auszuwerten und die Prüfungsformate im Hinblick auf Schwierigkeit, Reliabilität und Bestehensquoten zu bewerten. Analysiert wurden aggregierte Jahreswerte (2013–2024) für Schwierigkeit, Trennschärfe, Cronbach‑α und Angoff-Grenzen, auch Mittelwert und Standardabweichung wurden berechnet. Schriftlicher und mündlicher Teil wurden getrennt und vergleichend ausgewertet. Die schriftliche Prüfung wies eine mittlere Schwierigkeit (Anteil korrekt beantworteter Items) von 67

Perioperative care in ear surgery plays a central role in treatment success. However, significant differences in clinical standards may exist, especially in the absence of evidence-based guidelines. Given the increasing complexity of otologic procedures and the importance of high-quality postoperative care, standardizing measures is essential to minimize complications and improve outcomes.Thirty multiple-choice questions on pre-, peri-, and postoperative standards at participants' clinics were distributed via an online survey to members of the Otology Section of the German-speaking Association of Audiologists, Neurotologists, and Otologists (ADANO).Responses from 14 participants revealed considerable heterogeneity in perioperative care. Differences were particularly evident in the use of ear packing, administration of antibiotics and glucocorticoids, and postoperative behavioral recommendations (e.g., physical activity, protection from noise and water). Postoperative follow-up examinations such as the Weber tuning fork test or nystagmus assessment are applied relatively uniformly.The results highlight current inhomogeneity in perioperative care in ear surgery, even among specialized centers. The survey outlines current practices as expert opinion but lacks high-level evidence. Few high-quality studies systematically investigate the discussed standards, indicating a clear need for clinical research. Extending the survey to international otologic centers and experts would also be of interest.

Diagnostic testing prior to ear surgery is an important part of the work of ear specialists in hospitals. To date, there is no national or international diagnostic standard. Rather, the test batteries used are dependent on hospitals’ own doctrinal opinions. The aim of this study was to conduct a survey in German-speaking countries to determine the routine diagnostic methods used prior to various ear surgery procedures. An online questionnaire with 18 general questions on the hospital’s equipment and availability of tests and 6 questions on specific ear operations was sent to the departmental directors. Of the 180 hospitals contacted, 56 (31

Die perioperative Versorgung in der Ohrchirurgie spielt eine zentrale Rolle für den Behandlungserfolg. Dennoch bestehen möglicherweise erhebliche Unterschiede in den klinischen Standards, zumal evidenzbasierte Leitlinien fehlen. Angesichts der zunehmenden Komplexität ohrchirurgischer Eingriffe und der Bedeutung einer hochwertigen Nachsorge ist die Standardisierung von Maßnahmen essenziell, um Komplikationen zu minimieren und Ergebnisse zu verbessern. Dreißig Multiple-Choice-Fragen zu prä-, peri- und postoperativen Standards in der eigenen Klinik wurden den Mitgliedern der Otologie-Fachgruppe der Arbeitsgemeinschaft Deutschsprachiger Audiologen, Neurootologen und Otologen (ADANO) über einen Online-Fragebogen gestellt. Die Antworten der 14 Teilnehmenden zeigten teils erhebliche Heterogenität in der perioperativen Versorgung. Unterschiedliche Ansätze zeigten sich insbesondere bei der Verwendung von Tamponaden, der Gabe von Antibiotika und Glukokortikoiden sowie bei postoperativen Verhaltensempfehlungen (z.B. sportliche Aktivität, Schutz vor Lärm und Wasser). Postoperative Kontrolluntersuchungen wie der Stimmgabel-Test nach Weber oder die Nystagmusprüfung werden relativ einheitlich angewendet. Die Ergebnisse verdeutlichen die aktuelle Inhomogenität der prä-, peri- und postoperativen Versorgung in der Ohrchirurgie, selbst in spezialisierten Zentren. Die Umfrage liefert eine Übersicht über gelebte Praktiken im Sinne einer Expertenmeinung, bietet jedoch keine höhere Evidenz. Derzeit gibt es kaum Studien in ausreichender Qualität, die die diskutierten Standards systematisch untersucht hätten – hier besteht klinischer Forschungsbedarf. Von Interesse wäre zudem, die Umfrage auf internationale ohrchirurgische Zentren und Experten auszuweiten.

Myringoplasty is a routine surgery to restore the hearing of patients with a subacute and chronic tympanic membrane (TM) perforation. Electrospun scaffolds as a new art of synthetic TM replacement have a great potential to overcome the drawbacks of currently used autologous tissues due to the nano- and microfibers. Most recently with the development of tissue engineering, efforts have been made to mimic the radial and circular fiber arrangement of human TM to generate comparable acoustic vibration and mechanical stability. However, a convincing solution is still missing because of the lack of deep understanding the role of fiber arrangement in the oscillatory function. Therefore, the aim of this study is to systematically investigate the effect of fiber arrangement of TM implants on acousto-mechanical behavior based on finite element (FE) simulation. Electrospun 2D flat and 3D conical TM implants were designed in the FE model as nanofibrous composites with additional micro-filaments to mimic the radial and circular arrangement of collagen fibers as well as tailored fiber/filament structures. Not only harmonic acoustic vibration but also static mechanical deformation were simulated to get a systematic connection between the fiber arrangement in the native TM and its acousto-mechanical behavior. The results show that centering circular fibers at the umbo has a major contribution to improving acoustic vibration behavior while radial fibers entail a higher mechanical stability. The hybrid structure FFS3 that has the same fraction of radial and circular fibers shows promising results, since the implant design combines a higher acoustic compliance and a lower static deformation.

Intraoperative assessment of ossicular chain mobility remains challenging in reconstructive middle-ear surgery because conventional palpation is subjective. To better predict the postoperative air-bone gap (ABG) and guide decisions on whether revision surgery may be beneficial for hearing restoration, a more refined intraoperative assessment that differentiates the degree of ossicular chain mobility reduction is required. In this ex vivo study, we evaluated whether quasi-static stiffness measurements can predict sound transmission. Twelve human cadaveric temporal bones were mounted on a robotic setup in which a force-sensing needle robotically executed a standardized palpation sequence along a predefined trajectory, enabling calculation of direction-specific stiffness metrics. Stepwise artificial stiffening of the annular ligament, the stapes superstructure and the surrounding anatomical spaces of the tympanic cavity with thin layers of UV-curable resin produced graded sound transmission losses across up to five increments (for a total of ≈20-30 dB). The derived stiffness metrics tracked this decline only partially and anisotropically, with changes corresponding to <10 dB equivalents in specific probing directions. Nevertheless, binomial generalized linear models identified stiffness thresholds that discriminated among clinically relevant ABG categories (<10 dB, 10-20 dB, >20 dB). Similar trends were observed in three additional specimens with an opened incudostapedial joint. These finding demonstrate that quantitative force measurements or simplified surgical tools fitted to specific force thresholds could potentially provide surgeons with an intraoperative evaluation support tool.

To ensure continuous, standardized documentation of postoperative courses after ear surgery. This partial analysis focuses on quantifying the occurrence and frequency of specific complications. A complication registry was implemented to provide quality indicators, facilitating early detection and dynamic assessment. In this prospective, single-centre cohort study, 2,120 patients who underwent primary or revision middle ear surgery (Jan 2019 – Jun 2022) were entered in the registry and evaluated. Complications were assessed during regular follow-up visits and analysed dynamically using the Kaplan–Meier estimator, introducing the Complication Persistence Function (CPF) as a novel metric. A total of 528 (24.9

BACKGROUND:Structured oral examinations (SOEs) are valid instruments to assess applied knowledge and reasoning skills (competency level 2). They bridge the gap between written examinations focusing on factual knowledge (level 1) and practical formats such as objective structured clinical evaluations (OSCEs) assessing performance skills (from level 3). Through standardized case vignettes, checklists, and defined scoring criteria, SOEs offer potential for enhanced objectivity, reliability, and comparability. OBJECTIVE:Using pure tone audiometry (PTA) and rhinomanometry (RMM) as examples, this study examined the feasibility, psychometric quality (internal consistency, item discrimination, factor analysis), and examiner effects of an SOE designed according to the Nationaler Kompetenzbasierter Lernzielkatalog Medizin (NKLM), competency level 2. METHODS:Within the curricular ENT teaching program, PTA (n = 217) and RMM (n = 190) were taught and subsequently assessed in an SOE. Five categories were rated (identification, performance, description, interpretation, and differential diagnosis; maximum 27 points), with point deductions for examiner assistance. Eight medical examiners conducted the exams in a 1:1 setting. Descriptive statistics and a one-way analysis of variance (ANOVA) were used to analyze examiner differences. RESULTS:The mean total score was 25.20 ± 1.94 for PTA and 24.84 ± 1.94 for RMM. The highest scores were obtained for identification and performance, the lowest for description (PTA) and interpretation (RMM). Significant examiner differences were found for PTA (p = 0.001) but not for RMM (p = 0.078). CONCLUSION:The SOE proved to be a feasible and reliable format for assessing applied knowledge and reasoning. The observed examiner differences highlight the need for examiner training, calibration, and standardized scoring instruments. Structured oral examinations can substantially contribute to implementing competency-based assessment in medical education.

Strukturierte mündliche Prüfungen (SMP) sind ein valides Instrument zur Abbildung von Handlungs- und Begründungswissen (Stufe 2). Sie schließen die Lücke zwischen schriftlichen Formaten (Faktenwissen, Stufe 1) und praktischen Formaten wie „objective structured clinical evaluation“ (OSCE; Handlungskompetenz, ab Stufe 3). Durch standardisierte Fallvignetten, Checklisten und definierte Bewertungsmaßstäbe bieten SMP Potenzial für Objektivität, Reliabilität und Vergleichbarkeit. Am Beispiel der Reintonaudiometrie (RTA) und Rhinomanometrie (RMM) wurden Durchführbarkeit, Bewertungsgüte (interne Konsistenz, Trennschärfen, Faktorenanalyse) und Prüfer:inneneffekte einer SMP gemäß Kompetenzstufe 2 des Nationalen Kompetenzbasierten Lernzielkatalogs Medizin (NKLM) untersucht. Im curricularen Unterricht wurden RTA (n = 217) und RMM (n = 190) vermittelt und anschließend in einer SMP geprüft. Bewertet wurden 5 Kategorien (Benennung, Durchführung, Beschreibung, Interpretation, Differenzialdiagnose; maximal 27 Punkte) mit Abzügen bei Hilfestellungen. Acht ärztliche Prüfer:innen führten die Prüfungen im 1:1-Setting durch. Neben deskriptiver Statistik erfolgte eine einfaktorielle ANOVA („analysis of variance“) zur Analyse von Prüferunterschieden. Die mittlere Gesamtpunktzahl betrug 25,20 ± 1,94 (RTA) bzw. 24,84 ± 1,94 (RMM). Höchste Werte zeigten Benennung und Durchführung, niedrigste Werte fanden sich für Beschreibung (RTA) bzw. Interpretation (RMM). Für die RTA ergaben sich signifikante Prüferunterschiede (p = 0,001), für die RMM keine (p = 0,078). Die SMP erwies sich als praktikables und reliables Format zur Abbildung von Handlungs- und Begründungswissen. Der Nachweis einzelner Prüferunterschiede verdeutlicht die Notwendigkeit von Prüfer:innenschulungen, Kalibrierung und standardisierten Instrumenten. Damit kann die SMP wesentlich zur Umsetzung kompetenzorientierter Prüfungen im Medizinstudium beitragen.