Search

Abstract Objective To analyze medical device reports (MDR) submitted to the Food and Drug Administration's (FDA) Manufacturer and User Device Facility Experience (MAUDE) database to identify adverse events (AEs) in patients implanted with novel active bone conduction hearing implants (BCIs). Methods We conducted a search of the FDA MAUDE database on the newest generation of BCIs. Data were collected concerning device malfunctions, patient injuries, factors triggering these incidents, and the subsequent actions taken. Results In total, 93 (16.7%) device malfunctions and 465 (83.3%) patient injuries with 358 subsequent interventions were identified, resulting in 558 AEs. Although the absolute AE number per device cannot be identified, the following trends were detected: Among the 494 AEs associated with OSI200, 55 (11.1%) reported device malfunctions and 454 (88.9%) cited patient injuries. Out of the 64 AEs linked to BCI602, 28 (59.4%) were associated with malfunctions, whereas 26 (40.6%) involved patient injuries. The most frequently reported particular AEs for the OSI200 were infection (n = 171, 34.6%), extrusion of the device (n = 107, 21.7%), and pain (n = 51, 10.3%). Conversely, no device output (n = 20, 31.3%) and loss of osseointegration (n = 7, 10.9%) were the most reported AEs for the BCI602. Various AEs led to 214 explanations and 77 revision surgeries. Sixty‐seven AEs reported conservative treatment. Conclusion The current study provides an overview of the most commonly reported complications with new active BCIs. Although providing an overview, given the limitations of the FDA MAUDE database, our results have to be interpreted with caution. Level of Evidence 4.

BackgroundClimate change has been associated with a higher frequency of extreme weather events, resulting in an overall increase in morbidity and mortality. Acute otitis media (AOM) is one of the most common otolaryngological infections and accounts for 1.5% of emergency department visits. This study aimed to identify associations between extreme weather events and the immediate and delayed risks for AOM-related emergency department visits (EV).MethodsA total of 1,465 AOM-related EVs were identified in the Vienna General Hospital between 2015 and 2018. A distributed lag non-linear model was applied to evaluate the relationship between extreme weather conditions and the total number of AOM-related EVs per day. The relative risk (RR) and cumulative RR (cRR) of single-day events and extended weather events over three days were analyzed over a lag period of 14 days.ResultsAOM-related EVs showed a pronounced seasonality, with the highest occurrence during winter. Single-day weather events affected AOM-related EVs only at high relative humidity. Prolonged extreme weather conditions over three days, however, significantly increased the cRR for AOM-related EVs to 3.15 [1.26–7.88; p = 0.014] and 2.14 [1.14–4.04; p = 0.018] at mean temperatures of −4°C (1st-percentile - p1) and 0°C (p5) on the same day. Relative humidity of 37% (p1) decreased RR to 0.94 [0.88–0.99; p = 0.032] on day 7, while extremely high humidity of 89% (p99) led to an increased cRR of 1.43 [1.03–2.00; p = 0.034] on day 7. Heavy prolonged precipitation of 24mm (p95) reduced cRR beginning day 4 up until day 14 to 0.52 [0.31–0.86; p = 0.012]. Prolonged low atmospheric pressure events of 985hPa (p5) reduced the RR to 0.95 [0.91–1.00; p = 0.03], whereas extremely high atmospheric pressure events of 1013hPa (p99) increased the RR to 1.11 [1.03–1.20; p = 0.008]. Extremely low wind speeds significantly diminished the RR of AOM-related EVs.ConclusionsWhile single-day extreme weather events had little impact on the occurrence of AOM-related EVs, extended periods of extreme temperatures, relative humidity, precipitation, wind speeds and atmospheric pressure significantly impacted the RR for AOM-related EVs. These findings could help improve healthcare resource allocation in similar climates and aid in educating patients about the role of environmental factors in AOM.

Background: Robotic surgery has been proposed in various surgical fields to reduce recovery time, scarring, and to improve patients' outcomes. Such innovations are ever-growing and have now reached the field of cochlear implantation. To implement robotic ear surgery in routine, it is of interest if preoperative planning of a safe trajectory to the middle ear is possible with clinically available image data.Methods: We evaluated the feasibility of robotic cochlear implant surgery in 50 patients (100 ears) scheduled for routine cochlear implant procedures based on clinically available imaging. The primary objective was to assess if available high-resolution computed tomography or cone beam tomography imaging is sufficient for planning a trajectory by an otological software. Secondary objectives were to assess the feasibility of cochlear implant surgery with a drill bit diameter of 1.8 mm, which is the currently used as a standard drill bit. Furthermore, it was evaluated if feasibility of robotic surgery could be increased when using smaller drill bit sizes. Cochlear and trajectory parameters of successfully planned ears were collected. Measurements were carried out by two observers and the interrater reliability was assessed using Cohen's Kappa.Results: Under the prerequisite of the available image data being sufficient for the planning of the procedure, up to two thirds of ears were eligible for robotic cochlear implant surgery with the standard drill bit size of 1.8 mm. The main reason for inability to plan the keyhole access was insufficient image resolution causing anatomical landmarks not being accurately identified. Although currently not applicable in robotic cochlear implantation, narrower drill bit sizes ranging from 1.0 to 1.7 mm in diameter could increase feasibility up to 100%. The interrater agreement between the two observers was good for this data set.Discussion: For robotic cochlear implant surgery, imaging with sufficient resolution is essential for preoperative assessment. A slice thickness of

BackgroundThe data retrieved with the online search engine, Google Trends, can summarize internet inquiries into specified search terms. This engine may be used for analyzing inquiry peaks for different medical conditions and symptoms. ObjectiveThe aim of this study was to analyze World Wide Web interest peaks for “ear pain,” “ear infection,” and “ear drops.” MethodsWe used Google Trends to assess the public online interest for search terms “ear pain,” “ear infection,” and “ear drops” in 5 English and non–English-speaking countries from both hemispheres based on time series data. We performed our analysis for the time frame between January 1, 2004, and December 31, 2019. First, we assessed whether our search terms were most relevant to the topics of ear pain, ear infection, and ear drops. We then tested the reliability of Google Trends time series data using the intraclass correlation coefficient. In a second step, we computed univariate time series plots to depict peaks in web-based interest. In the last step, we used the cosinor analysis to test the statistical significance of seasonal interest peaks. ResultsIn the first part of the study, it was revealed that “ear infection,” “ear pain,” and “ear drops” were the most relevant search terms in the noted time frame. Next, the intraclass correlation analysis showed a moderate to excellent reliability for all 5 countries’ 3 primary search terms. The subsequent analysis revealed winter interest peaks for “ear infection” and “ear pain”. On the other hand, the World Wide Web search for “ear drops” peaked annually during the summer months. All peaks were statistically significant as revealed by the cosinor model (all P values

BackgroundThe aim of this study was to evaluate whether surgeons´ experience and perioperative single-shot antibiotic prophylaxis affect outcome of patients undergoing stapes surgery.Patients and methodsWe retrospectively evaluated audiological outcomes and postoperative complications of 538 consecutive patients who underwent stapes surgery at a single tertiary referral center between 1990 and 2017. Effects of different clinical variables, including single-shot antibiotic prophylaxis and surgeons' experience on outcome were assessed.Results538 patients underwent 667 stapedotomies and postoperative complication rate was 7.5% (n = 50). Air conduction and air-bone gap closure improved significantly after surgery (14.2 ± 14.8 dB, p = 0.001; 14.5 ± 12.8 dB, p = 0.001). Multivariate analysis revealed that 6 years or less of surgical experience was independently associated with a higher incidence of persisting or recurrent conductive hearing loss (p = 0.033, OR 5.13) but perioperative application of antibiotics had no significant effect on outcome.ConclusionFirst, clinical outcome regarding persisting or recurrent conductive hearing loss caused by incus necrosis and prosthesis luxation is linked to surgical performance. This underlines the need for a meticulous training and supervision of less experienced surgeons performing stapes surgery. Second, our results do not support the need for perioperative antibiotic prophylaxis in stapes surgery. Potential standard limitations of retrospective cohort studies (selection bias, confusion bias etc.) could play a role in interpreting our results. However, the probability for these limitations is minimized due to the large patient sample.

Objective: The aim of this study was to evaluate whether stapes prostheses can be visualized with less metal artifacts and therefore more accurately on cone beam computed tomography in comparison to computed tomography imaging. Recent studies have shown that cone beam computed tomography has advantages when imaging metal artifacts. Patients with hearing loss or vertigo, who have undergone stapedotomy, often present a challenge for otologic surgeons. Imaging studies can deliver crucial additional information. Methods: A retrospective analysis of imaging studies and clinical data in a tertiary care center were carried out. Forty-one patients with forty-five implanted ears were evaluated in the study. All included patients had been implanted with a platinum–fluoroplastic (n = 19) or titanium (n = 26) piston and subsequently had undergone imaging months or years after surgery for various reasons. Patients underwent computed tomography or cone beam computed tomography of the temporal bone depending on availability. Piston visualization, prosthesis length, vestibular intrusion and audiologic results were compared between the groups. Piston position on imaging studies were compared to intraoperative findings. Results: Functional length measurements of all prostheses were carried out with a mean error of −0.17 mm (±0.20). Platinum–fluoroplastic protheses were significantly underestimated in length compared to titanium prostheses. To analyze the material-dependent difference in the measurement errors of the imaging techniques the interaction was tested in an ANOVA model and showed no statistically significant result (p = 0.24). The blinded neuroradiologist viewed two implants, both platinum–fluoroplastic pistons, as located outside of the vestibule due to an underestimation of the prothesis length and the missing radiodensity of the lower end of the prosthesis. Conclusion: Surgeons and radiologists should be aware of the different types and radiologic features of stapes prostheses and the missing radiodensity of some protheses parts. Cone beam computed tomography is an imaging alternative with a potential advantage of reduced radiation in patients after stapes surgery suffering from vertigo or hearing loss to evaluate piston position.

To determine the impact of the fixed and adaptive beamforming technology of the new MED-EL SONNET cochlear implant audio processor on speech perception in noise.The study cohort comprises 18 postlingually deafened adult cochlear implant recipients with at least six months of experience. Speech reception thresholds were measured with the Oldenburg Sentence Test in continuous, speech-shaped noise. Target sentences were presented in front of the listener, with noise sources placed at -135° and 135°, respectively. Outcome measures were the differences in speech reception threshold using omnidirectional, fixed and adaptive beamformer microphone settings.The use of directional microphones significantly improved speech reception thresholds: fixed beamformer vs. omnidirectional: 4.3 dB (95%-CI [3.1; 5.5]), p

This study evaluated the expression of galectin-3 in 101 curettage specimens from normal, hyperplastic, and neoplastic endometrial tissues using immunohistochemistry. The histologic diagnoses were as follows: normal proliferative (n = 8) and secretory (n = 4) phase, simple hyperplasia (SH, n = 16), complex hyperplasia without atypia (CH, n = 11), atypical hyperplasia (AH, n = 13), endometrioid adenocarcinoma (EC, n = 35), serous papillary carcinoma (SPC, n = 10), and clear cell carcinoma (CC, n = 4). Immunostaining was scored with regard to the approximate percentage of positive tumor cells and relative staining intensity. The scores of immunostaining increased significantly from NE, SH, CH, and AH to the adenocarcinomas (ANOVA, p < 0.0001). Subsequently, three significantly different levels of galectin-3 expression were found (Newman-Keuls multiple comparison test). These consisted of (a) NE, SH, and CH, (b) AH and EC, and (c) SPC and CC. Galectin-3 expression increased with tumor grade (ANOVA, p = 0.0026). The scores of FIGO stages I to III did not differ significantly (ANOVA, p = 0.1687). Enhanced nuclear galectin-3 expression was noted in carcinomas, immunostaining of stromal cells decreased in the latter. This study shows that galectin-3 expression increases from normal and hyperplastic to atypical hyperplastic and cancerous states of endometrial tissues, and provides further evidence of a relationship between AH and EC. [ABSTRACT FROM AUTHOR]