Darío H. Scocco, María A. Barreiro, Iván E. García
{"title":"“Sitting-up vertigo as an expression of posterior semicircular canal heavy cupula and posterior semicircular canal short arm canalolithiasis”","authors":"Darío H. Scocco, María A. Barreiro, Iván E. García","doi":"10.1016/j.joto.2022.02.001","DOIUrl":"10.1016/j.joto.2022.02.001","url":null,"abstract":"<div><h3>Background</h3><p>Vestibular symptoms on sitting-up are frequent on patients seen by vestibular specialists. Recently, a benign paroxysmal positional vertigo (BPPV) variant which elicits vestibular symptoms with oculomotor evidence of posterior semicircular canal (P-SCC) cupula stimulation on sitting-up was described and named sitting-up vertigo BPPV. A periampullar restricted P-SCC canalolithiasis was proposed as a causal mechanism.</p></div><div><h3>Objective</h3><p>To describe new mechanisms of action for the sitting-up vertigo BPPV variant.</p></div><div><h3>Methods</h3><p>Eighteen patients with sitting-up vertigo BPPV were examined with a pre-established set of positional maneuvers and follow-up until they resolved their symptoms and clinical findings.</p></div><div><h3>Results</h3><p>All patients showed up-beating torsional nystagmus (UBTN) and vestibular symptoms on coming up from either Dix-Hallpike (DHM) or straight head-hanging maneuver. Sixteen out of 18 patients presented a sustained UBTN with an ipsitorsional component to the tested side on half-Hallpike maneuver (HH). A slower persistent contratorsional down-beating nystagmus was found in eleven out 18 patients tested on nose down position (ND).</p></div><div><h3>Conclusions</h3><p>Persistent direction changing positional nystagmus on HH and ND positions indicative of P-SCC heavy cupula was found in 11 patients. A sustained UBTN on HH with the absence of findings on ND, which is suggestive of the presence of P-SCC short arm canalolithiasis, was found on 5 patients. All patients were treated with canalith repositioning maneuvers without success, but they resolved their findings by means of Brandt-Daroff exercises. We propose P-SCC heavy cupula and P-SCC short arm canalolithiasis as two new putative mechanisms for the sitting-up vertigo BPPV variant.</p></div>","PeriodicalId":37466,"journal":{"name":"Journal of Otology","volume":"17 2","pages":"Pages 101-106"},"PeriodicalIF":0.0,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/61/a0/main.PMC9349016.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40600968","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lucas Resende Lucinda Mangia , Gabriel Lucca de Oliveira Salvador , Bettina Carvalho , Rogério Hamerschmidt
{"title":"Measuring the density of the fissula antefenestram and the section of the basal turn of the cochlea: Are they useful in the radiological diagnosis of otosclerosis?","authors":"Lucas Resende Lucinda Mangia , Gabriel Lucca de Oliveira Salvador , Bettina Carvalho , Rogério Hamerschmidt","doi":"10.1016/j.joto.2022.01.001","DOIUrl":"10.1016/j.joto.2022.01.001","url":null,"abstract":"<div><h3>Introduction</h3><p>The role of objective parameters in terms of improvement of the accuracy of high-resolution computed tomography (HRCT) of the temporal bone in the diagnosis of otosclerosis remains unclear.</p></div><div><h3>Objectives</h3><p>To investigate the relationship between the density of the fissula antefenestram (FAF) and of the width of the transversal section of the basal turn of the cochlea (BTC), and the diagnosis of otosclerosis.</p></div><div><h3>Methods</h3><p>This is a retrospective study in which preoperative HRCT data from ears of patients submitted to stapedotomy due to otosclerosis (case group) were evaluated. For the control group, normal hearing ears having undergone HRCT for other purposes were included. Case and control HRCT images were objectively assessed by an experienced blinded radiologist. During this evaluation, measurements of the relative radiological density of the FAF and of the transversal section of the BTC were obtained. The results were compared between the groups. Also, a receiver operating characteristic curve was created and the area under the curve (AUC) was calculated for each variable. Significance level was set at .05.</p></div><div><h3>Results</h3><p>40 ears were included in each group. Case ears presented reduced values for the relative radiological density on the FAF (p-value<0.0001). Moreover, ears with otosclerosis (p-value: 0.022) presented lower transversal section of the BTC. The AUC for these variables reached 0.929 and 0.646, respectively.</p></div><div><h3>Conclusions</h3><p>Otosclerotic ears present reduced radiological density on the FAF and narrower BTC. The relative density of the FAF also shows a great diagnostic power in the context of this disease.</p></div>","PeriodicalId":37466,"journal":{"name":"Journal of Otology","volume":"17 2","pages":"Pages 84-89"},"PeriodicalIF":0.0,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/d2/a1/main.PMC9349010.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40600972","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kenneth Wei De Chua , Heng Wai Yuen , David Yong Ming Low , Savitha Hosangadi Kamath
{"title":"The prevalence of isolated otolith dysfunction in a local tertiary hospital","authors":"Kenneth Wei De Chua , Heng Wai Yuen , David Yong Ming Low , Savitha Hosangadi Kamath","doi":"10.1016/j.joto.2021.06.003","DOIUrl":"10.1016/j.joto.2021.06.003","url":null,"abstract":"<div><h3>Objective</h3><p>Patients with dizziness may present with symptoms of tilting, swaying, rocking, floating or with disequilibrium. This may be suggestive of an isolated otolithic dysfunction yet, there is little emphasis on this emerging clinical entity. To characterize and describe the prevalence of isolated otolith dysfunction in a local tertiary hospital and correlate them with clinical diagnosis.</p></div><div><h3>Methodology</h3><p>Retrospective medical chart review of patients who presented with dizziness to the specialist outpatient Otolaryngology clinic, who required vestibular laboratory investigation.</p></div><div><h3>Results</h3><p>Of the 206 patients, more than half of them (52.4%) fulfilled the criteria for either probable or definite isolated otolith dysfunction. When there are clinical symptoms of otolith dysfunction reported, there is a 1.62 odds of a remarkable laboratory otolith finding. The most common clinical finding was “no clear diagnosis” (65.5%) followed by Vestibular Migraine (13.6%).</p></div><div><h3>Conclusion</h3><p>The prevalence of isolated otolith dysfunction is quite high. Laboratory tests of otolith function should be performed more routinely. This can be done in a sequential way to optimize cost effectiveness in countries with no insurance reimbursement. Prospective cohort studies on isolated otolith dysfunction, will lay the groundwork for achieving diagnostic consensus and formulating rehabilitation plans to aid this group of patients.</p></div>","PeriodicalId":37466,"journal":{"name":"Journal of Otology","volume":"17 1","pages":"Pages 5-12"},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.joto.2021.06.003","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10318578","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
András Molnár, Stefani Maihoub, László Tamás, Ágnes Szirmai
{"title":"A possible objective test to detect benign paroxysmal positional vertigo. The role of the caloric and video-head impulse tests in the diagnosis","authors":"András Molnár, Stefani Maihoub, László Tamás, Ágnes Szirmai","doi":"10.1016/j.joto.2021.11.001","DOIUrl":"10.1016/j.joto.2021.11.001","url":null,"abstract":"<div><h3>Background</h3><p>Benign paroxysmal positional vertigo (BPPV) is characterized by vertigo lasting from seconds to minutes, induced by head movements.</p></div><div><h3>Objectives</h3><p>Our study aimed to investigate the clinical significance of the caloric vestibular and video head-impulse tests (vHIT) diagnosing the disorder.</p></div><div><h3>Methods</h3><p>68 patients suffering from posterior canal BPPV (25 male, 43 females, mean age <span><math><mrow><mo>±</mo></mrow></math></span> SD, 54.5 <span><math><mrow><mo>±</mo></mrow></math></span> 13.2 years) and 56 patients with a normal functioning vestibular system as control were investigated. Bithermal caloric test and vHIT was performed during the same medical check-up. Canal paresis (CP%), gain (GA) and asymmetry (GA%) parameters were calculated.</p></div><div><h3>Results</h3><p>The Dix-Hallpike manoeuvre was only positive in 4% of this population. The CP% parameter was only pathologic in two patients, and there was no significant difference between control and BPPV patients (p = 0.76). The GA value was never under 0.8 in this population, but GA% was abnormal in 63.2%. A significant difference comparing the GA% values to the control group was seen (p = 0.034). There was no correlation detected between the CP% and GA% values in BPPV. Regarding the GA% value, 61% sensitivity and 76% specificity was seen.</p></div><div><h3>Conclusion</h3><p>The Dix-Hallpike manoeuvre was not often positive in the non-acute phase of BPPV; therefore, objective testing is essential. The caloric test does not have clinical significance in BPPV, but vHIT can be helpful based on the GA% parameter.</p></div>","PeriodicalId":37466,"journal":{"name":"Journal of Otology","volume":"17 1","pages":"Pages 46-49"},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/46/26/main.PMC8811404.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39609453","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Stefani Maihoub, András Molnár, László Tamás, Ágnes Szirmai
{"title":"The diagnosis of central vestibular disorders based on the complementary examination of the vestibulospinal reflex","authors":"Stefani Maihoub, András Molnár, László Tamás, Ágnes Szirmai","doi":"10.1016/j.joto.2021.07.001","DOIUrl":"10.1016/j.joto.2021.07.001","url":null,"abstract":"<div><h3>Objectives</h3><p>Stance and gait unsteadiness along with vertigo contribute to a central vestibular disorder. For objective analysis ultrasound-computer-craniocorpography (US-COMP-CCG) can be used. Aim of the study was to characterize the unsteadiness in central vestibular disorders and discuss the possible diagnostic usage of US-COMP-CCG.</p></div><div><h3>Methods and results</h3><p>Hundred-and-ninety patients (70 male and 120 female, mean age ± SD, 58.94 ± 15.27) suffering from central vestibular disorder and 230 healthy control patients (78 male and 152 female, mean age ± SD, 50.94 ± 15.27) were enrolled. Stance and gait analysis was according to vestibulospinal tests of US-COMPCCG. IBM SPSS V24 software was used for statistical analysis. Mann-Whitney<em>U</em> test and Chi-square test were used, along with sensitivity and specificity categorization. The significance level was p < 0.05. According to schematic and statistical analysis instability and postural sway were increased in the vertigo population and statistically significant difference was shown. Upon categorical analysis significant correlation was detected [standing test: longitudinal sway (p < 0.00001), lateral sway (p < 0.00001), forehead covering area parameters (p = 0.0001); stepping test: longitudinal deviation (p = 0.05), lateral sway (p = 0.011) parameters].</p></div><div><h3>Conclusions</h3><p>Clinicians should consider that postural instability is prominently present in this population and might be of a diagnostic importance.</p></div>","PeriodicalId":37466,"journal":{"name":"Journal of Otology","volume":"17 1","pages":"Pages 1-4"},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.joto.2021.07.001","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39780955","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Feng Xin , Qingfeng Li , Fangling Guan , Minli Suo , Jie Yang , Dan Li , Changqing Zhao
{"title":"The study on psychological resilience of tinnitus and associated influencing factors","authors":"Feng Xin , Qingfeng Li , Fangling Guan , Minli Suo , Jie Yang , Dan Li , Changqing Zhao","doi":"10.1016/j.joto.2021.08.001","DOIUrl":"10.1016/j.joto.2021.08.001","url":null,"abstract":"<div><p>The association between tinnitus and psychological resilience is an underdeveloped area of research. This cross-sectional study investigated such associations and factors potentially affecting resilience in 61 patients. Demographic and psychometric data were collected by questionnaires. The Connor–Davidson Resilience Scale (CD-RISC), Medical Coping Modes Questionnaire (MCMQ), Satisfaction with Life Scale (SWLS), General Self-Efficacy Scale (GSES), Big Five Inventory (BFI) and Perceived Social Support Scale (PSSS) were completed by participants. Data were analyzed using independent <em>t-</em>test and Pearson's correlation analysis and multiple linear regression modeling. The CD-RISC score was relatively low (66.97 ± 15.71), negatively correlated with tinnitus (r = −0.276, <em>p</em> < 0.001) and associated with age (r = 0.270,P<0.001). As protective factors, SWLS (r = 0.486, <em>p</em> < 0.001), GSES (r = 0.555, <em>p</em> < 0.001), PSSS (r = 0.538, <em>p</em> < 0.001) and extraversion were positively correlated with CD-RISC and BFI scores (r = 0.287, <em>p</em> < 0.001). We also detected a negative correlation with neuroticism (r = −0.395, <em>p</em> < 0.001), which is a known risk factor for worse CD-RISC scores. Identifying protective and risk factors for psychological resilience can be used to predict treatment outcomes in tinnitus patients, which will help devise personalized solutions and improve patients' quality of life.</p></div>","PeriodicalId":37466,"journal":{"name":"Journal of Otology","volume":"17 1","pages":"Pages 13-17"},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.joto.2021.08.001","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39780956","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Himanshu Verma , Banumathy N , Roshani Mishra , Naresh K. Panda
{"title":"Outcome measures following tele-rehabilitation and conventional face to face rehabilitation in paediatric cochlear implant users during COVID-19 pandemic: A pilot study in a tertiary care setup","authors":"Himanshu Verma , Banumathy N , Roshani Mishra , Naresh K. Panda","doi":"10.1016/j.joto.2021.10.002","DOIUrl":"10.1016/j.joto.2021.10.002","url":null,"abstract":"<div><h3>Background</h3><p>Following the COVID-19 pandemic, majority of paediatric cochlear implantees (CI) lost follow ups for rehabilitation and tele-therapy was initiated. Present study thus compared the outcome measures of paediatric CI users on tele-therapy versus conventional face to face therapy following COVID-19 pandemic.</p></div><div><h3>Method</h3><p>Twenty seven unilateral paediatric cochlear implantees in the age range of 2–11 years were divided into two groups based on the therapy modality, viz, tele- and face-to-face therapy. Based on the hearing age, participants were further divided into three groups, viz, 0–2, 2–4, and greater than four years. A complete the test battery comprising Integrated Scales of Development, Speech Intelligibility Rating scale, and Revised Categorical Auditory Perception were administered. The speech & language test battery was performed prior to initiating the rehabilitation and post 12 months of rehabilitation.</p></div><div><h3>Results</h3><p>Results of the present study revealed that conventional rehabilitation had better outcomes compared to teletherapy. The rate of progress after one year of rehabilitation with respect to hearing-age showed a significant difference for the hearing-age group of 0–2 years across the domains of audition, speech and language.</p></div><div><h3>Conclusion</h3><p>The present study indicates that conventional method of the speech-language and auditory rehabilitation is far better compared to the tele rehabilitation services especially for those visiting tertiary care hospitals as most of them belong to lower and middle socioeconomic status. From the results, it can be delineated that with lesser hearing experience, paediatric CI users always need to initially enroll for conventional therapy for better speech-language and auditory outcomes.</p></div>","PeriodicalId":37466,"journal":{"name":"Journal of Otology","volume":"17 1","pages":"Pages 31-38"},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/82/f2/main.PMC8559455.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39851096","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Molecular mechanisms and roles of inflammatory responses on low-frequency residual hearing after cochlear implantation","authors":"Juanjuan Gao, Haijin Yi","doi":"10.1016/j.joto.2021.03.001","DOIUrl":"10.1016/j.joto.2021.03.001","url":null,"abstract":"<div><p>Preservation of low-frequency residual hearing is very important for combined electro-acoustic stimulation after cochlear implantation. However, in clinical practice, loss of low-frequency residual hearing often occurs after cochlear implantation and its mechanisms remain unclear. Factors affecting low-frequency residual hearing after cochlear implantation are one of the hot spots in current research. Inflammation induced by injury associated with cochlear implantation is deemed to be significant, as it may give rise to low-frequency residual hearing loss by interfering with the blood labyrinth barrier and neural synapses. Pathological changes along the pathway for low-frequency auditory signals transmission may include latent factors such as damage to neuroepithelial structures, synapses, stria vascularis and other ultrastructures. In this review, current research on mechanisms of low-frequency residual hearing loss after cochlear implantation and possible roles of inflammatory responses are summarized.</p></div>","PeriodicalId":37466,"journal":{"name":"Journal of Otology","volume":"17 1","pages":"Pages 54-58"},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.joto.2021.03.001","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39609455","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Yanqing Fang , Wei Chen , Liu-Jie Ren , Sebastian Kiehn , Yilai Shu , Bing Chen
{"title":"Stability of computed tomography densitometry in patients with otosclerosis:a two-year follow-up","authors":"Yanqing Fang , Wei Chen , Liu-Jie Ren , Sebastian Kiehn , Yilai Shu , Bing Chen","doi":"10.1016/j.joto.2021.10.003","DOIUrl":"10.1016/j.joto.2021.10.003","url":null,"abstract":"<div><h3>Objectives</h3><p>To quantify the progression of otosclerosis in the unoperated ear between two stapedotomy procedures for patients with bilateral otosclerosis which can help to determine whether a HRCT scan should be re-performed before the second surgery for patients who already received HRCT imaging before the initial surgery.</p></div><div><h3>Methods</h3><p>35 patients who underwent bilateral stapedotomy were included. Two rounds of HRCT examination and audiometry were performed at the time of the first surgery and second surgery on the ear that was not operated on during the initial surgery. The relationship between the changes in HRCT densitometry and audiometry over time was analyzed.</p></div><div><h3>Results</h3><p>The second round of HRCT did not add significant information about the changes to the otosclerosis lesions in either the imaging diagnosis or the HRCT density values except for small changes in the HRCT densitometry readings at the area anterior to the inner auditory (P = 0.01). While the changes in HRCT manifestation are small, changes near the fissula ante fenestram (FAF) were still positively correlated with the air bone gap (ABG) of patients (p = 0.031, r = 0.388).</p></div><div><h3>Conclusions</h3><p>The progression of lesions in otosclerosis is slow resulting in small and insignificant changes to the HRCT features. Therefore, a repeat HRCT evaluations prior to surgery is not necessary for patients who have had a previous HRCT evaluation within 2 years of the operation. The small changes in HRCT manifestation near the FAF were still correlated with negative effects on the ABG which could cause worsened hearing thresholds over this timeframe.</p></div>","PeriodicalId":37466,"journal":{"name":"Journal of Otology","volume":"17 1","pages":"Pages 39-45"},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/d6/5f/main.PMC8811413.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39609452","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jaclyn Carey, Sairisheel Gabbireddy , Luke Mammen , Gianna Rosamilia , Varun Patel, David Foyt, Steven Parnes
{"title":"FDA MAUDE database analysis of titanium middle ear prosthesis","authors":"Jaclyn Carey, Sairisheel Gabbireddy , Luke Mammen , Gianna Rosamilia , Varun Patel, David Foyt, Steven Parnes","doi":"10.1016/j.joto.2021.08.002","DOIUrl":"10.1016/j.joto.2021.08.002","url":null,"abstract":"<div><h3>Purpose</h3><p>Partial ossicular replacement (PORP) and total ossicular replacement prostheses (TORP) are used to restore ossicular chain function. Despite favorable auditory outcomes, these interventions have associated risks and complications. This study examines the FDA MAUDE database for ossicular chain prosthesis adverse events to highlight complications, interventions, and root cause analysis (RCA) findings.</p></div><div><h3>Materials and methods</h3><p>The MAUDE database was searched for Medical Device Reports (MDRs) relating to PORPs and TORPs from 2010 to 2020. MDR event descriptions were reviewed, and adverse events were identified as a device issue, patient issue, and/or packaging issue that occurred intraoperatively or postoperatively.</p></div><div><h3>Results</h3><p>Our search identified 70 MDRs which included 110 reported adverse events. Events consisted of 63 device issues, often due to device breaks and displacements, 39 patient issues, including common complaints of hearing loss and erosion, and 8 packaging issues. When comparing PORPs and TORPs, TORPs had more reported device issues whereas PORPs had more packaging issues. Intraoperative device issues were commonly resolved by completing the procedure with a backup device and most postoperative device issues required additional surgery. For devices returned to the manufacturer, RCA determined that most breaks were caused by modification and/or mishandling or that the product met specifications with an undetermined cause for the break.</p></div><div><h3>Conclusion</h3><p>Device issues were the most common adverse events and frequently required subsequent intervention. Displacement occurred more often with TORPs and was associated with changes in hearing or erosion. The findings of this study are purely descriptive and may not have direct clinical relevance.</p></div>","PeriodicalId":37466,"journal":{"name":"Journal of Otology","volume":"17 1","pages":"Pages 18-24"},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.joto.2021.08.002","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39609450","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}