Safety and performance of the new med-el total ossicular replacement prostheses.

PURPOSE: This multicentric, retrospective study provides safety and performance data of the MED-EL total ossicular replacement prostheses (TORP). METHODS: Patients underwent tympanoplasty with mXACT Total Prosthesis Center, mXACT Total Prosthesis Offcenter or mXACT PRO Total Prosthesis. The clinical data were retrospectively analyzed. Follow-up examination included access to the medical record (for adverse events) of the patients, ear microscopy and pure-tone audiometry to determine the post-operative pure tone average of the frequencies 0.5, 1, 2 and 3 kHz (PTA4). The post-operative PTA4 air bone gap (ABG) was used to evaluate the audiological outcome. A post-operative minimum and maximum follow-up period was not defined. RESULTS: 103 patients were implanted with a TORP. 102 (88 adults, 14 children; 37 CHL, 64 MHL, 1 not specified) patients were analyzed for safety and 92 (79 adults, 13 children) patients for performance of the prostheses. ADVERSE EVENTS RESULTS (N = 102): In 1 patient (child, mXACT Total Prosthesis Offcenter) a prosthesis dislocation was reported, which lead to a revision surgery. No prosthesis extrusion or migration was reported. AUDIOLOGICAL RESULTS (N = 92): 49 (53.3%) of the 92 patients had a PTA4 ABG of ≤ 20 dB and therefore a successful rehabilitation. The mean post-operative PTA4 ABG of all 92 patients was 21.0 ± 9.7 dB. The first endpoint, improvement in post-operative PTA4 ABG of ≤ 20 dB by ≥ 25% of the patients was achieved. The individual Δ BC PTA4 (post-operative minus pre-operative BC PTA4) thresholds were stable (within ± 5 dB HL) in 91 (98.9%) patients. 1 patient had a BC PTA4 deterioration of 11.3 dB HL. CONCLUSION: The MED-EL TORPs are safe and effective for middle ear reconstruction. Trial registration number NCT05565339, September 09, 2022, retrospectively registered.

[Trauma of the midface : Symptoms, diagnostics and treatment]. / Trauma des Mittelgesichts : Symptomatik, Diagnostik und Therapie.

Midface fractures present a clinical challenge in otorhinolaryngology due to their often complex injury pattern and nonspecific symptoms. Precise diagnostics, including differentiated imaging procedures, are required. Interdisciplinary consultation between otorhinolaryngology, maxillofacial surgery, neurosurgery, and ophthalmology is often necessary. When selecting radiographic modalities, radiation hygiene should be taken into account. Sonography provides a radiation-free imaging alternative for fractures of the nasal framework and anterior wall of the frontal sinus. The goal of treatment is to achieve stable and symmetrical reconstruction. Depending on the injury pattern, different osteosynthesis materials, individual access routes, and various surgical procedures can be used. In clinical practice, the management of midface fractures requires a multidisciplinary, flexible, and pragmatic approach based on the fracture pattern and clinical experience.

[Communication training in otorhinolaryngology education : Comparison of an online and a classroom-based training course]. / Vermittlung kommunikativer Kompetenzen in der Lehre der HNO-Heilkunde : Vergleich zwischen einer Online- und Präsenzveranstaltung.

BACKGROUND: Communication skills are among the most important key qualifications of the medical profession. To what extent these can also be acquired online in medical education in otolaryngology is investigated in this study. OBJECTIVE: A voluntary online training for the teaching of communication skills was compared with a corresponding face-to-face format. The question of the extent to which acceptance of the two formats and students' self-assessment of their communicative skills differed was investigated. MATERIALS AND METHODS: In the online training, students were prepared for the topic asynchronously via a video. Thereafter, they were able to conduct consultations with simulation patients online and synchronously. The face-to-face training was comparable in structure and duration and took place in an earlier semester. The acceptance of both seminars was assessed by a questionnaire with 19 items on a five-point Likert scale. Self-assessment of communication skills was measured by a 10-cm visual analog scale pre/post with 16 items. RESULTS: Both formats achieved high acceptance with an average score (M) of 2.08 (standard deviation, SD = 0.54) for the online format and M = 1.97 (SD = 0.48) for the face-to-face event. Students' self-assessments of communication skills showed a twofold increase in the online group (M = 1.54, SD = 0.94) compared to the face-to-face group (M = 0.75, SD = 0.87). CONCLUSION: This study shows that teaching communication skills in the online format was well accepted and resulted in significant changes in students' self-assessment of communication skills.

"Seeing inside out": revealing the effectiveness of otoscopy training in virtual reality enhanced practical exams - a randomized controlled trial.

BACKGROUND: The study aimed to assess the impact of different training modalities on otoscopy performance during a practical exam using a high-fidelity simulator and to determine if objective evaluation of otoscopy is feasible using a simulator that records insertion depth and tympanic membrane coverage. METHODS: Participants were assigned to one of four groups: control and three intervention groups with varying training approaches. Participants received otoscopy training and then were assessed through a practical exam on a high-fidelity simulator that uses virtual reality to visualize the ear canal and middle ear. Performance was evaluated using a modified Objective Structured Assessment of Technical Skills checklist and Integrated Procedural Performance Instrument checklist. Insertion depth, tympanic membrane coverage, and correct diagnosis were recorded. Data were tested for normal distribution using the Shapiro-Wilk test. One-way ANOVA and, for non-normally distributed data, Kruskal-Wallis test combined with Dunn's test for multiple comparisons were used. Interrater reliability was assessed using Cohen's κ and Intraclass correlation coefficient. RESULTS: All groups rated their training sessions positively. Performance on the OSATS checklist was similar among groups. IPPI scores indicated comparable patient handling skills. The feedback group examined larger tympanic membrane areas and had higher rates of correct diagnosis. The correct insertion depth was rarely achieved by all participants. Interrater reliability for OSATS was strong. IPPI reliability showed good correlation. CONCLUSION: Regardless of training modality, participants perceived learning improvement and skill acquisition. Feedback improved examination performance, indicating simulator-guided training enhances skills. High-fidelity simulator usage in exams provides an objective assessment of performance.

Short-term safety and effectiveness of the mCLIP partial prosthesis.

PURPOSE: This multicentric, retrospective study aimed to analyze the short-term safety and effectiveness of the mCLIP Partial Prosthesis. METHODS: Patients underwent tympanoplasty with implantation of a mCLIP Partial Prosthesis. Follow-up examination included ear microscopy and pure-tone audiometry to determine the post-operative pure tone average of the frequencies 0.5, 1, 2 and 3 kHz (PTA4). The post-operative PTA4 air bone gap (ABG) was used to evaluate the audiological outcome. A post-operative minimum and maximum follow-up period was not defined. Thus, the follow-up times of each study center were different, which resulted in different follow-up times for the audiological analysis and for adverse events (AE). RESULTS: 72 (66 adults, 6 children) patients were implanted with the mCLIP Partial Prosthesis. 68 (62 adults, 6 children) patients underwent audiological examination; all 72 patients were examined for adverse events. All patients (N = 68): 72.1% of the patients showed a PTA4 ABG of ≤ 20 dB. Individual post-operative bone conduction (BC) PTA4 thresholds were stable in 67 patients. The mean post-operative follow-up time was 78 ± 46 days. Children (N = 6): 5 out of 6 children showed a PTA4 ABG of ≤ 20 dB. None of the children reported a BC PTA4 deterioration of > 10 dB HL after the implantation. The mean post-operative follow-up time was 101 ± 45 days. Adverse events (all patients, N = 72): 15 (14 adults, 1 child) patients had AEs (27 AEs and 2 Follow-Ups). The mean post-operative follow-up time was 375 days. CONCLUSION: Clinical data show satisfactory audiological parameters after implantation of the mCLIP Partial Prosthesis. The prosthesis is safe and effective for implantation in children and adults. TRIAL REGISTRATION NUMBER: NCT05565339, 09 September 2022, retrospectively registered.

[Digital health applications in otorhinolaryngology]. / Digitale Gesundheitsanwendungen in der Hals­, Nasen- und Ohrenheilkunde.

BACKGROUND: With the passing of the "Digital Care Act" by the German Bundestag at the end of 2019, it was made possible, among other things, for digital health applications to be reimbursed by statutory health insurance companies under certain conditions. The aim of this work is to identify digital health applications related to ear, nose, and throat medicine and to describe the underlying evidence. MATERIALS AND METHODS: The digital health applications register was analyzed to identify digital health applications with an indication area relating to an otorhinolaryngologic disease. Digital health applications were included that were either permanently or provisionally included, or currently deleted if further information was available. The underlying evidence was assessed according to the recommendations of the Oxford Center for Evidence-Based Medicine for therapeutic studies. RESULTS: A total of six digital health applications with a direct or indirect connection to otorhinolaryngology were identified, three of which were permanently and two provisionally included in the directory. One digital health application has currently been withdrawn by the manufacturer. The permanently recorded digital health applications are based on evidence level 1b. CONCLUSION: The introduction of digital health applications is sometimes also discussed critically, but they represent an innovative approach and various digital health applications with a high level of underlying evidence are already available, especially for the ear, nose, and throat area.

[Midface traumatology: one focus-more than two specialist disciplines?] / Traumatologie des Mittelgesichts: ein Fokus ­ mehr als zwei Fachdisziplinen?

Midface fractures are a common occurrence and may be associated with other injuries. It is important to perform diagnosis and treatment planning on an interdisciplinary basis. CT is the gold standard diagnostic modality. Classification according to the pattern of fracture is via the LeFort and other systems. Treatment objectives are anatomic repositioning to preserve the function of the eyes, the infraorbital nerve, and facial symmetry, as well as to preserve masticatory function. The number of surgical access routes should be minimized and incisions of the facial skin avoided wherever possible.

[From Learning Objective to Examination: Constructive Alignment in Education and Training]. / Vom Lernziel zur Prüfung: Constructive Alignment in der Aus- und Weiterbildung.

An examination that is as transparent, performance-based, and fair as possible is something that teachers and learners both desire. This article is intended to help sharpen the basic understanding of examination designs and to shed light on the variable interplay of teaching and examination formats. This article is intended to help sharpen the basic understanding of examination designs and to shed light on the variable interplay of teaching and examination formats.

[Acute care of soft tissue injuries in the head and neck region]. / Akutversorgung von Weichteilverletzungen im Kopf-Hals-Bereich.

BACKGROUND: Soft tissue injuries are a common consequence of head and neck trauma. With injuries being highly individual and varying depending on the underlying trauma, it is difficult to establish standardized guidelines for head and neck trauma in general. The main goal of this study was to showcase the distribution of soft tissue injury types and the principles pertaining to acute care of the individual clinical presentations. MATERIALS AND METHODS: A retrospective evaluation was carried out using all trauma-relevant ICD-10 codes for trauma to the head (S00.- to S09.-) and neck (S10.- to S19.-) among patients who were treated at the authors' clinic-a certified national trauma center-during a period of 10 years (2012 to and including 2021). RESULTS: A total of 8375 patients with head and neck trauma were treated during the observation period, i.e., an average of 836 patients per year. Within this collective, 2981 trauma cases involving soft tissue injuries were documented. Superficial injuries to the head (S00.-) and open wounds to the head (S01.-) were the most common head and neck soft tissue injuries, with 1649 and 920 cases, respectively. CONCLUSION: The case numbers of soft tissue injuries generally show an inverse correlation to the required underlying trauma: diagnoses of the categories S00 and S01 occur very often; injuries which only occur after severe trauma, such as traumatic amputation at neck level (S18), are rare. According to current literature, penetrating neck traumas should be treated using a no-zone approach. In Europe, penetrating neck injuries are rather rare because of low crime rates and strict weapon laws.

[Evaluation of a structured e-learning-based approach to CT anatomy of the paranasal sinuses for medical students : A pilot study]. / Evaluation eines strukturierten E­Learning-basierten Ansatzes zur Vermittlung der CT-Anatomie der Nasennebenhöhlen bei Medizinstudierenden : Eine Pilotstudie.

BACKGROUND: Computed tomography (CT) anatomy is not an integral part of undergraduate medical training in many countries. Radiology seems to be well suited for new online-based teaching methods. OBJECTIVE: The aim of this study was to evaluate whether e­learning is appropriate for introducing complex learning contents such as sinus CT anatomy to novices and to assess whether identification of relevant anatomical variants in sinus CT scans by medical students can be improved with a sinus CT checklist. MATERIALS AND METHODS: Medical students were asked to assess sinus CT scans for anatomical variants before and after implementation of the CLOSE mnemonic (cribriform plate, lamina papyracea, Onodi cell, sphenoid sinus pneumatization, and [anterior] ethmoidal artery). Sinus CT anatomy and the CLOSE mnemonic were introduced by e­learning. The rate of correctly identified variants and the results of the individual CLOSE items were recorded. A questionnaire was distributed for subjective evaluation of the usefulness of the checklist and e­learning. RESULTS: Ten students took part in this pilot study. The rate of correctly identified variants improved significantly, from 33.3 to 61.1%. The analysis of the individual CLOSE items showed a significant improvement for C, S, and E. The subjective evaluation of the CLOSE mnemonic and e­learning was very positive. CONCLUSION: E­learning was able to transfer complex learning contents in previously non-trained medical students and was evaluated as an appropriate introduction to the topics. Structured assessment of paranasal sinus CT scans using the CLOSE criteria can significantly improve the recognition of anatomical variants.

[Establishing an ORL virtual outpatient Dept. during the COVID-19 pandemic]. / Erstellung einer virtuellen HNO-Ambulanz in der Lehre während der COVID-19-Pandemie.

INTRODUCTION: The COVID-19 pandemic changed medical education: teaching has been mostly converted to online mode. Our aim is to offer a complete high-quality curriculum despite the fact of worldwide cutbacks in education. METHODS: The department of otorhinolaryngology introduced case-based learning (CBL). CBL is a learning and teaching approach that prepares students for clinical practice through the use of authentic clinical cases and places them in the role of decision maker. CBL combines theory and practice to prepare students as good as possible without intern shadowing. The students were asked to evaluate CBL as a digital format and as a teaching tool for future clinical work and preparation for the ORL exam. RESULTS: The majority of students (>90%) rated the CBL as a successful digital format. Most students also strongly agreed or agreed that CBL is a good preparation for their future clinical work (>90%) and the ORL exam (>80%). 100% of students CBL confirmed, that they learned something new. CONCLUSION: Following successful introduction of CBL we will implement a new teaching format. The "ORL virtual outpatient Dept." will include information from virtual, anonymized case studies. We choose diagnosis included in the "ORL virtual outpatient Dept." according to the most common ORL disorders encountered by primary care physicians. The "ORL virtual outpatient Dept." can only bridge the absence of practical training, and, in the future, serve as an additional preparation.