The silent reservoir? SARS-CoV-2 detection in the middle ear effusion of patients with Otitis media with effusion after omicron infection.

PURPOSE: This multicenter, prospective study is designed to investigate whether severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is present in the Middle Ear Effusion (MEE) of patients developing Otitis Media with Effusion (OME) subsequent to an Omicron infection. The objective is to elucidate any potential association between the virus and the condition. METHODS: This study, conducted from January to June 2023, spanned the Otolaryngology departments of two medical institutions in Eastern China. Patients manifesting OME subsequent to Omicron infection from both hospitals were subjected to comprehensive otolaryngological assessments, including pure-tone audiometry (PTA), tympanometry, otoscopic examination, and nasopharyngolaryngoscopy. Subsequently, MEE samples extracted from these patients were analyzed through RT-PCR to detect SARS-CoV-2. RESULTS: In this study, 23 patients (32-84 years; 57.5 ± 14.8 mean age; 47.8 % male) presented OME in 25 ears post-Omicron infection, with 21 (91.3 %) exhibiting unilateral symptoms. The median duration from infection to MEE sampling was 21 days (IQR: 25-46; range: 11-150). Predominantly, 64.0 % exhibited Type B tympanograms, and fluid accumulation was observed in 88.0 % of ears. SARS-CoV-2 was detected in 3 MEE samples (12.0 %), with cycle threshold values ranging between 25.65 and 33.30. CONCLUSIONS: Our study highlights the potential effects of COVID-19 on the middle ear, suggesting a link between SARS-CoV-2 and OME onset. The virus, a significant contributor to OME, is detectable in the MEE nearly a month post-Omicron infection, indicating a potential alteration in OME treatment strategies and a risk of recurrence, emphasizing the necessity for otolaryngologist vigilance.

Permanent occlusion of the Eustachian tube: a retrospective study on reopening procedures.

PURPOSE: This study retrospectively evaluated the efficacy and versatility of reopening procedures for the permanent occlusion of the cartilaginous Eustachian tube (POET) by analyzing four consecutive cases. METHODS: The study included all patients diagnosed with POET who suffered from Eustachian tube occlusion and glue ear. A combined approach of endoscopic transnasal/transoral laser surgery was utilized to reopen the POET. This was subsequently followed by balloon dilation (BET) and stenting for a duration of six weeks. In one distinct case, the Eustachian tube orifice was approached via a transtympanic method, where a balloon catheter was placed. The primary outcome measures targeted the success rate of reopening, which was quantified using audiological outcomes and Eustachian tube patency verified by a positive Valsalva maneuver. RESULTS: Four patients, with an age range of 14-62 years (mean age of 29.3 years), were subject to Eustachian tube reopening. The duration of follow-up varied between 10 and 24 months, averaging at 16.2 months. Notably, 75% of the surgically treated ears displayed no evidence of glue ear upon their last follow-up and showed restoration of Eustachian tube patency. The procedures were executed without any surgical complications. The causes for POET in these patients were heterogeneous: two were attributed to scarring post adenoidectomy, one to occlusion following orthognathic surgery and the remaining one due to prior radiotherapy treatment for squamous cell carcinoma located at the soft palate. DISCUSSION: Total occlusion of the cartilaginous Eustachian tube may be linked to persistent middle ear diseases. It is imperative to conduct nasopharyngeal endoscopy in these cases. The findings from this study suggest that the Eustachian tube reopening procedure is predominantly effective and safe for patients with POET stemming from a variety of pathologies. Future research should focus on exploring advanced stenting devices and necessitate longer follow-up periods for comprehensive understanding.

Prevalence of middle ear effusion in French bulldogs without clinical signs of otic disease: A retrospective study of magnetic resonance imaging (2017-2022).

BACKGROUND: Canine middle ear effusion (MEE) is usually asymptomatic, being an incidental finding when computed tomography or magnetic resonance imaging (MRI) of the head is performed for other reasons unrelated to otic disease. The clinical relevance of the presence of material in the tympanic bulla (TB) remains uncertain, and more detail about its prevalence and appearance in MRI are required. OBJECTIVE: To assess the prevalence of presence of material within the TB of French bulldogs (FB) with no clinical signs suggestive of otitis (externa, media or interna) that underwent high-field MRI for other medical reasons. ANIMALS: Two hundred fifty-two TB of 126 FB were included in this study. MATERIALS AND METHODS: Nonexperimental retrospective study in which MRI images were evaluated by a board-certified veterinary radiologist. RESULTS: Fifty-eight per cent of the dogs had material in the TB lumen (46% of the TB) and 59% were bilaterally affected. The signal intensity of this material related to the grey matter was variable on T1w and mainly hyperintense on T2w sequences. CONCLUSION AND CLINICAL RELEVANCE: FB are predisposed to MEE. This is important when assessing imaging studies of TB of FB with chronic otitis externa, as high percentage of cases may have concurrent MEE. MRI findings in FB with MEE are characterised by a hyperintense signal to the grey matter on T2w in most cases and variable on T1w sequences.

Case report of bilateral middle ear effusion requiring myringotomy and tube placement following inferior U-shaped nasopharyngeal flap elevation for endonasal odontoidectomy: investigation of causality.

We describe a patient with symptomatic os odontoideum and a previous history of C1-2 wiring who underwent successful treatment with a staged endonasal odontoidectomy and C1-2 revision of instrumentation. Access to the odontoid process was gained through the endonasal corridor using an inverted U-shaped nasopharyngeal flap (IUNF). Post-operatively, the patient experienced resolution of her presenting neurologic symptoms but developed conductive hearing loss secondary to bilateral middle ear effusion, requiring bilateral myringotomy and tube placement 3 months post-operatively. We hypothesize this dysfunction may have resulted from surgical edema, packing buttressing the IUNF, or some combination thereof. In this manuscript, we review the evolution of the nasopharyngeal exposure for odontoidectomy and whether an IUNF may predispose to this complication.

The association between Helicobacter pylori and chronic otitis media with effusion.

PURPOSE: Chronic otitis media with effusion (COME) is a common condition in children and a leading cause for hearing loss and ventilation tubes (VT) insertion. Among other risk factors, it is suggested that Helicobacter pylori (H. pylori) infection may have a role in the pathogenesis of COME. Previous studies have reached different results, and therefore, there is a need for further data on the relationship between H. pylori infection and COME development in children. Our objective is to investigate the presence of H. pylori in the middle-ear fluid (MEF) from children with COME. METHODS: A Comparative cross-sectional study. Children ≤ 18 years were included. The study group included children diagnosed with COME and required VT insertion. The control group included children with acute otitis media (AOM) who required myringotomy in the emergency room. Middle-ear fluid samples were sent for both culture and bacterial identification using polymerase chain reaction (PCR) testing. RESULTS: A total of 43 children were included. Eighteen with COME (median age 4 years, IQR 3-6), and 25 with AOM (median age 1 year, IQR 1-2). All samples were cultured for H. pylori. Twenty-two samples underwent H. pylori PCR testing of them, 12 samples from children with COME, and 10 from children with AOM. All cultures and PCR tests results were negative for H. pylori. CONCLUSIONS: Our results suggest that H. pylori does not have a role in the pathogenesis of COME. Future larger studies are needed to investigate whether H. pylori has a role in the pathogenesis of COME.

COVID-19-related secretory otitis media in the omicron era: a case series.

OBJECTIVES: Increased numbers of patients with secretory otitis media appeared in outpatient clinics after the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) Omicron pandemic; however, the relationship between SARS-CoV-2 Omicron variant infection and secretory otitis media is uncertain. METHODS: We performed tympanocentesis and used reverse transcription-polymerase chain reaction (RT-PCR) testing to examine middle ear effusion (MEE) and nasopharyngeal secretions from 30 patients with secretory otitis media associated with SARS-CoV-2 infection. RT-PCR was performed using the open reading frame 1ab and nucleocapsid protein gene kit from Shanghai Berger Medical Technology Co., Ltd., as the sole assay method, in accordance with the manufacturer's instructions. RESULTS: MEEs from 5 of the 30 patients tested positive for SARS-CoV-2, including one patient with positive results for both the nasopharyngeal secretion and MEE. We report and discuss the medical records of six patients, including these five MEE-positive patients and a MEE-negative patient. CONCLUSION: SARS-CoV-2 RNA can be detected in MEE caused by coronavirus disease 2019-related secretory otitis media even when a patient's nasopharyngeal secretion tests PCR-negative for SARS-CoV-2. The virus can remain in the MEE for a long time after SARS-CoV-2 infection.

Middle ear effusion and newborn hearing screening.

PURPOSE: Middle ear effusion (MEE) is one of the reasons for screening failure and may require prolonged follow-up due to conductive hearing loss. We aimed to examine at 1-year follow-up, the fate of MEE. METHODS: From medical charts, computerized data were collected retrospectively of newborns born in the years 2012-2013 in Rambam Health Care Campus, Haifa city, Israel, who failed the Universal Newborn Hearing Screening (UNHS), and follow-up hearing evaluation data were extracted. RESULTS: Of 9527 newborns born in 2012-2013 in our institution, 144 [1.5%] failed the UNHS, and 46 were eventually diagnosed with conductive hearing loss caused by MEE. Spontaneous MEE clearance was recorded in 12 [26%], while 26 [57%] patients had persistent effusion that required further follow-up (10 [22%] required insertion of ventilation tubes and 16 [35%] were referred for further follow-up); 8 [17%] were lost to follow-up. CONCLUSION: Congenital MEE causing conductive hearing loss and UNHS failure is persistent and resolves at lower rates than non-congenital MEE.

Eustachian tube dysfunction in an intensive care unit: A prospective observational study.

Background: Eustachain tube (ET) dysfunction can aggravate the morbidity in ICU patients, but is often ignored. In this prospective observational study we followed a cohort of patients (without pre-existing ET dysfunction) requiring in-patient management, hospitalized either to ICU or to non ICU wards, for any development of ET dysfunction during hospitalization. Methods: Patients requiring hospitalization to ICU or non ICU wards from Dec 2018 to Jun 2019 were included. Those with pre-existing ET dysfunction, disease of ear/nose or sinuses, head neck tumours and history of radiotherapy or glucocorticoid therapy were excluded. All patients were evaluated by serial tympanometry. Type A curve was considered normal while type B, C1 and C2 were considered as ET dysfunction. Results: There were 385 patients, 258 (67.01%) males and 127 (32.99%) females in the ICU group; while non ICU group comprised 129 patients, 86 (66.67%) males and 43 (33.33%) females. ET dysfunction developed in 107 (27.79%) patients in ICU group, but only in 3 (2.3%) in non ICU group (Relative risk 11.95, 95% CI 3.86 to 36.99, P < 0.0001). Within ICU, ET dysfunction showed significant positive association with endotracheal intubation, Ramsay sedation score and number of days on tracheostomy; but not with age, male gender, number of days in ICU, mechanical ventilation or route of feeding. Conclusion: Our study demonstrates high incidence of ET dysfunction in patients admitted to ICU.

Otitis Media and Hearing Loss in Patients With Nonsyndromic Craniosynostosis: A Multicenter Study.

OBJECTIVES: The objectives of this study were to: (1) determine the prevalence of otitis media with effusion in patients with nonsyndromic craniosynostosis; (2) determine the prevalence of hearing loss in patients with nonsyndromic craniosynostosis; and (3) identify potential patterns and outcomes in patients with nonsyndromic craniosynostosis. METHODS: A retrospective chart review was conducted at 2 academic institutions, St Christopher's Hospital for Children and SUNY Upstate Medical University, from January 2015 through August 2018, to identify patients having nonsyndromic craniosynostosis with a concurrent diagnosis of otitis media and/or hearing loss. The demographic data and categorical variables were analyzed using descriptive statistics and chi-square testing, respectively. RESULTS: In the entire cohort of patients (N = 113, age range 0-123 months), 36% had otitis media with effusion on either history, physical examination, tympanometry, and/or imaging. Half (50%) of patients with coronal synostosis had otitis media with effusion compared to sagittal (40.7%), metopic (26.3%), multiple (25%), and lambdoid (0%). However, these differences were not statistically significant (P = .190). Most patients had normal hearing (91%), while a minority had either conductive (7%) or sensorineural (2%) hearing loss. CONCLUSION: The presence of otitis media in our cohort of patients with nonsyndromic craniosynostosis appears to be at the upper limit of normal when compared to historical rates in normocephalic children. Synostosis subtype did not appear to predict the presence of otitis media. Only 9% of patients with nonsyndromic craniosynostosis were found to have a hearing loss.

Use of an autoinflation device does not lead to a clinically meaningful change in hearing thresholds in children with otitis media with effusion.

DESIGN: The objective of this study was to establish whether autoinflation was an effective intervention in a paediatric audiology service. This was a pragmatic retrospective study with historical controls using a paired availability design. SETTING: The study took place at a single paediatric audiology service in England. PARTICIPANTS: All children seen in the clinic over a two-year period who were aged between 3 and 11 years and who had a type B tympanogram in at least one ear were included. The Otovent autoinflation device was available as a treatment option over the second year (Cohort B) but not the first (Cohort A). There were 976 children included in the study: Cohort A comprised 513 children, Cohort B comprised 463 children. MAIN OUTCOME MEASURES: The aims were to evaluate whether there was improvement in hearing thresholds following introduction of an autoinflation device, and whether there was a reduction in further audiology follow-ups, and in referrals to an ear, nose and throat specialist for consideration of ventilation tube insertion. RESULTS AND CONCLUSIONS: There was a statistically significant improvement in hearing thresholds in Cohort B compared to Cohort A, however the improvements were clinically minimal with small effect sizes. There was no significant difference in improvement of tympanometry results between the two cohorts. Significantly more children in Cohort B (autoinflation group) were referred to an ear, nose and throat specialist after their second appointment compared to Cohort A. It was feasible to introduce autoinflation into the care pathway, however there was no evidence of clinically meaningful improved outcomes for patients.

Otitis media in children: Which phenotypes are most linked to allergy? A systematic review.

BACKGROUND: Allergic rhinitis is a common childhood disease responsible for a major impact on quality of life and healthcare resources. Many hypotheses have been proposed to explain the link between allergy and otitis media, although a definitive mechanism has not been identified yet. One of the major critical points is that authors failed in distinguishing among different phenotypes of middle ear inflammation. This review pointed out literature evidence from the laboratory and clinical experience linking allergy to different phenotypes of otitis media in children. METHODS: We performed a systematic review in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) process. Our search yielded 3010 articles that were finally screened. This resulted in 20 manuscripts of which the full texts were included in a qualitative analysis. We paid particular attention in distinguishing among phenotypes of otitis media. RESULTS: Clinical evidence and analyses of biomarkers suggested that allergy may be linked to some phenotypes of otitis media and, in particular, to otitis media with effusion (OME) and acute re-exacerbations in children with middle ear effusion. It was not possible to perform the analysis for allergy and acute and chronic otitis media because of paucity and heterogeneity of data. CONCLUSION: Allergy should be considered in the diagnostic workup of children with OME as well as OME should be excluded in children with persistent moderate to severe AR. In these cases, clinicians should evaluate prompt and accurate treatment of allergy in improving outcomes, although futures studies are required to increase evidence supporting that anti-allergy treatment may be effective in the recovery and outcome of otitis media with effusion.

Tube patency: Is there a difference following otic drop administration?

PURPOSE: Many surgeons instill peri-operative otic drops to maintain tube patency. A post-hoc analysis of three randomized, controlled studies involving a one-time administration of ciprofloxacin (OTO-201) given instead of otic drops perioperatively was conducted to evaluate tube patency in patients who did and did not receive otic drops as defined within the study protocol. MATERIALS AND METHODS: Post-hoc, retrospective analysis from three prospective, randomized, double-blind trials, (Phase 1b study [n = 83] and two Phase 3 studies [n = 532]) which enrolled children with confirmed middle ear effusion on the day of tympanostomy tube surgery and then randomized to placebo/sham (tubes alone) or OTO-201 and studied over a 28-day observation period. Patients with observed otorrhea post-tube were provided otic drops in the studies. An analysis was performed on the combined studies to evaluate tube patency, determined by pneumatic otoscopy and tympanometry, at four defined study visits over 28 days after the initial tube placement. RESULTS: The analysis included 591 total patients with similar baseline demographics across groups. Tube patency ranged from 87 to 95% for patients who received otic drops, and from 96 to 99% for patients who did not receive otic drops. CONCLUSION: Based on a retrospective post-hoc analysis from three randomized controlled trials in nearly 600 patients, tympanostomy tube occlusion rates was not increased in patients who did not receive otic drops. From this analysis, occlusion is likely caused primarily by peri-operative otorrhea since patency rates approached 99% in the absence of this complication.

Safety and efficacy of intratympanic ciprofloxacin otic suspension post-tubes in a real-world pediatric population.

PURPOSE: Otorrhea frequently follows tympanostomy tube (TT) placement. We evaluated otorrhea following single 6mg OTO-201 (OTIPRIO®, ciprofloxacin otic suspension 6%) intraoperative injection into each middle ear in a variety of effusion types and concurrent procedures in children undergoing TT placement. SECONDARY OBJECTIVE: Efficacy based on Medicaid status and safety. BASIC PROCEDURES: In this prospective, 8-week, multicenter, open-label study, 501 patients were enrolled: mean age 2.9years, male (56.9%), wet/wet ears (66.9%), wet/dry (16.8%), dry/dry (16.3%), and Medicaid-insured (32.9%). MAIN FINDINGS: In per-protocol population (n=410), otorrhea rate through Day 15 were 8.8% (CI:5.7%-12.8%), 6.6% (CI:2.2%-14.7%), 3.3% (CI:0.4%-11.3%) in wet/wet, wet/dry, and dry/dry ears, respectively. For Medicaid patients through Day 15, Week 4 and Week 8, otorrhea rates were 8.1% (CI:4.1%-14.1%), 17.0% (CI:11.1%-24.5%), and 17.8% (CI:11.7%-25.3%) compared with those non-Medicaid insured: 7.3% (CI:4.5%-11.0%), 14.5% (CI:10.6%-19.3%), and 21.8% (CI:17.1%-27.2%), respectively. Safety was similar to previous Phase 3 trials. PRINCIPAL CONCLUSIONS: OTO-201 demonstrated otorrhea rates consistent with Phase 3 trials in a broader, real-world, ENT practice-based pediatric population. Outcomes were similar in Medicaid- and non-Medicaid insured patients. OTO-201 was well-tolerated.

The variation in quality and content of patient-focused health information on the Internet for otitis media.

BACKGROUND: When symptoms of otitis media appear, parents and patients often access the Internet for health information. We study the content and quality of health information in parent-patient-focused websites for otitis media. METHODS: We searched the 3 search engines (Google, Yahoo, and Bing) using "otitis media" and "middle ear infection" then reviewed the top 30 hits for each search. We included sites that were focused on providing patient-patient information about otitis media. A variety of instruments were used to assess website content and quality. RESULTS: In 35 included websites, there was considerable variation in content, with the average site having 11 out of 15 informational items potentially useful to parents and patients on otitis media (range 4-15). Across included websites, the mean DISCERN score was 47 out of 80 (low to medium quality), 16 (46%) were HONcode certified, and 8 (23%) fulfilled all the JAMA benchmark criteria. The average website was written at a 9th/10th-grade reading level. CONCLUSION: The content and quality of health information for otitis media in parent-and-patient-focused websites is highly variable. Although easy-to-read, high-quality websites with complete content are available, the average website sites is difficult to read without a high school education and is difficult to use. Consideration should be given to adopting a standard approach for presenting disease-specific information to parents and patients.

Computed tomographic morphometry of tympanic bulla shape and position in brachycephalic and mesaticephalic dog breeds.

Anatomic variations in skull morphology have been previously described for brachycephalic dogs; however there is little published information on interbreed variations in tympanic bulla morphology. This retrospective observational study aimed to (1) provide detailed descriptions of the computed tomographic (CT) morphology of tympanic bullae in a sample of dogs representing four brachycephalic breeds (Pugs, French Bulldogs, English Bulldog, and Cavalier King Charles Spaniels) versus two mesaticephalic breeds (Labrador retrievers and Jack Russell Terriers); and (2) test associations between tympanic bulla morphology and presence of middle ear effusion. Archived head CT scans for the above dog breeds were retrieved and a single observer measured tympanic bulla shape (width:height ratio), wall thickness, position relative to the temporomandibular joint, and relative volume (volume:body weight ratio). A total of 127 dogs were sampled. Cavalier King Charles Spaniels had significantly flatter tympanic bullae (greater width:height ratios) versus Pugs, English Bulldogs, Labrador retrievers, and Jack Russell terriers. French Bulldogs and Pugs had significantly more overlap between tympanic bullae and temporomandibular joints versus other breeds. All brachycephalic breeds had significantly lower tympanic bulla volume:weight ratios versus Labrador retrievers. Soft tissue attenuating material (middle ear effusion) was present in the middle ear of 48/100 (48%) of brachycephalic breeds, but no significant association was found between tympanic bulla CT measurements and presence of this material. Findings indicated that there are significant interbreed variations in tympanic bulla morphology, however no significant relationship between tympanic bulla morphology and presence of middle ear effusion could be identified.

[Seasonal differences of tympanogram and middle ear findings in children. German version]. / Saisonale Unterschiede von Tympanogramm- und Mittelohrbefund bei Kindern.

BACKGROUND: It is a known fact that bacterial or viral acute otitis media occurs more frequently in the winter months. Only a few older studies on seasonal differences in middle ear findings are available. These studies are based solely on tympanography, without correlation to intraoperative middle ear findings. This study addresses the question of whether seasonal differences can be found in the preoperative tympanogram and in the corresponding intraoperative findings in children with chronic middle ear problems. PATIENTS AND METHODS: This retrospective study included patients who had undergone myringotomy with or without tympanostomy tube insertion at the Charité-Universitätsmedizin Berlin between January and December 2011. Corresponding to the catarrhal phases, winter months were defined as those from November to April; summer months from May to October. The preoperative tympanogram and the documented intraoperative middle ear finding were statistically analyzed for seasonal differences. RESULTS: A total of 654 ears from 206 male and 127 female patients with mean age 3.7 ± 2.5 years were analyzed. In the majority of cases, a type B tympanogram was found (n = 376; 57.5%), whereas the middle ear was filled with air in 19.1% of cases. No significant seasonal differences were found for either the intraoperative middle ear findings or the preoperative tympanograms (p > 0.05). CONCLUSION: For children with a typical history of chronic otitis media without effusion and chronic tube ventilation dysfunction, myringotomy with or without tympanostomy tube insertion is indicated independently of the season. The results indicate that a wait-and-see approach with hope of improvement during the summer months is not rational.

Seasonal differences of tympanogram and middle ear findings in children.

BACKGROUND: It is a known fact that bacterial or viral acute otitis media occurs more frequently in the winter months. Only a few older studies on seasonal differences in middle ear findings are available. These studies are based solely on tympanography, without correlation to intraoperative middle ear findings. This study addresses the question of whether seasonal differences can be found in the preoperative tympanogram and in the corresponding intraoperative findings in children with chronic middle ear problems. PATIENTS AND METHODS: This retrospective study included patients who had undergone myringotomy with or without tympanostomy tube insertion at the Charité-Universitätsmedizin Berlin between January and December 2011. Corresponding to the catarrhal phases, winter months were defined as those from November to April; summer months from May to October. The preoperative tympanogram and the documented intraoperative middle ear finding were statistically analyzed for seasonal differences. RESULTS: A total of 654 ears from 206 male and 127 female patients with mean age 3.7 ± 2.5 years were analyzed. In the majority of cases, a type B tympanogram was found (n = 376; 57.5%), whereas the middle ear was filled with air in 19.1% of cases. No significant seasonal differences were found for either the intraoperative middle ear findings or the preoperative tympanograms (p > 0.05). CONCLUSION: For children with a typical history of chronic otitis media without effusion and chronic tube ventilation dysfunction, myringotomy with or without tympanostomy tube insertion is indicated independently of the season. The results indicate that a wait-and-see approach with hope of improvement during the summer months is not rational.

Functional MRI of the Eustachian Tubes in Patients With Nasopharyngeal Carcinoma: Correlation With Middle Ear Effusion and Tumor Invasion.

OBJECTIVE: We sought to combine the Valsalva maneuver with MRI to evaluate eustachian tube function in patients with nasopharyngeal carcinoma (NPC) and to correlate the extent of tumor invasion with the presence of middle ear effusion (MEE) and eustachian tube dysfunction (ETD). SUBJECTS AND METHODS: We performed MRI along the lengths of the eustachian tubes, before and after the Valsalva maneuver was performed, in 53 patients with untreated NPC. The images were reviewed by two radiologists. RESULTS: A total of 106 eustachian tubes and middle ears were studied. There was dysfunction in 37 eustachian tubes, which was always ipsilateral to the NPC. There was MEE in 26 ears of 22 patients. In all cases of MEE, there was ipsilateral ETD. ETD was correlated with tumor invasion of the ipsilateral pharyngeal recess (p < 0.001), pharyngeal opening of the eustachian tube (p < 0.001), the cartilaginous eustachian tube (p < 0.001), the eustachian cartilage (p < 0.001), Ostmann fat pad (p < 0.001), the levator veli palatine muscle (p < 0.001), and the tensor veli palatine muscle (p < 0.001). There was a strong correlation between the grade of parapharyngeal space invasion and ETD (r = 0.809; p < 0.001) and MEE (r = 0.693; p < 0.001). CONCLUSION: Combining the Valsalva maneuver with MRI is helpful in assessing the function of the eustachian tube in patients with NPC. The cause of MEE in patients with NPC is dysfunction of the eustachian tube opening, which is associated with tumor invasion around the eustachian tube.

Randomized Clinical Trial of a Sustained-Exposure Ciprofloxacin for Intratympanic Injection During Tympanostomy Tube Surgery.

OBJECTIVE: This exploratory clinical trial evaluated the safety and clinical activity of a novel, sustained-exposure formulation of ciprofloxacin microparticulates in poloxamer (OTO-201) administered during tympanostomy tube placement in children. METHODS: Double-blind, randomized, prospective, placebo- and sham-controlled, multicenter Phase 1b trial in children (6 months to 12 years) with bilateral middle ear effusion requiring tympanostomy tube placement. Patients were randomized to intraoperative OTO-201 (4 mg or 12 mg), placebo, or sham (2:1:1 ratio). RESULTS: Eighty-three patients (52 male/31 female; mean age, 2.80 years) were followed for safety (otoscopic exams, cultures, audiometry, and tympanometry) and clinical activity, defined as treatment failure (physician-documented otorrhea and/or otic or systemic antibiotic use ≥3 days post surgery). At baseline, 14.3% to 36.8% of children showed positive cultures of middle ear effusion samples in at least 1 ear. Through day 15, treatment failures accounted for 14.3%, 15.8%, 45.5%, and 42.9% of patients (OTO-201 4 mg, OTO-201 12 mg, placebo, and sham, respectively); treatment failure reductions for OTO-201 doses were significant compared to pooled control (P values = .023 and .043, respectively). Observed OTO-201 safety profile was indistinguishable from placebo or sham. CONCLUSIONS: Results of this first clinical trial suggest that OTO-201 was well tolerated and shows preliminary clinical activity in treating tympanostomy tube otorrhea.

Laser Myringotomy Versus Ventilation Tubes In Otitis Media With Effusion.

BACKGROUND: Otitis media with effusion (OME) is a leading cause of difficulty in hearing in paediatric population. Otitis media with effusion must be detected and managed early to prevent conductive hearing loss in children. It was aimed to compare results of laser myringotomy and ventilation tube insertion, in terms of hearing improvement and recurrence of Middle ear effusion (MEE). METHODS: This randomized controlled trial was conducted from February 2012 to January 2015. Children of 4- 12 years of age with decreased hearing due to OME were included in the study. These children were investigated with pure tone audiometry (PTA) and tympanometry to confirm conductive hearing loss. Patients were put in 2 groups, group one comprised of patients treated with laser myringotomy and group 2, treated with ventilation tube insertion. The objective was to evaluate and compare results of the two procedures in terms of resolution of middle ear effusion (MEE) and improvement of hearing. The two procedures were also compared in terms of complications like otorrhea, persistence of perforation, hypertrophic scar and thinning of tympanic membrane (TM). RESULTS: Middle ear effusion cleared in 35 out of 68 ears with laser myringotomy (LM) as compared to 52 out of 62 ears with ventilation tubes (VT). The myringotomy was still patent in 21 ears treated with LM while tube was in site in 50 years with VT after 3 months. The hearing level improved with LM by 10-15 dB after first 3 months. CONCLUSIONS: The aim in Otitis media with effusion is ventilation of tympanic cavity. Laser myringotomy can be substitute to ventilation tube insertion (VT). But it remains patent for shorter time and less effective than VT. The ears with refractory or recurrent MEE should have VT insertion.