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Background Otitis media with effusion (OME) is a common disease in ear, nose, and throat clinics characterized by aural fullness and hearing loss and mainly caused by eustachian tube dysfunction (ETD). Tympanostomy tube insertion (TTI) is a conventional surgical treatment option that can alleviate symptoms but does not provide a definitive cure, and it is prone to recurrence. Balloon dilation eustachian tuboplasty (BDET) has become a novel procedure for the treatment of ETD, demonstrating significant potential in addressing the aforementioned limitations. However, it is not widely available in the clinic and few high-quality randomized clinical trials was conducted to investigate its long-term efficacy and security in OME. Therefore, the purpose of this study is to verify the efficacy of BDET combined with TTI for patients with OME and its prospects for providing a definitive cure. Methods and analysis This is a prospective, parallel-group, single-blind, randomized controlled prospective trial. Totally 124 patients with OME will be randomized into either group A or B. Group A will receive conventional therapy (TTI) while group B will use BDET therapy in addition to TTI. Outcome assessments will take place at baseline and at the 3rd, 6th, 12th, and 24th months after surgery. The primary outcome is eustachian tube function, which will be measured by the eustachian tube dysfunction questionnaire (ETDQ-7) and eustachian tube score (ETS). The secondary outcomes include middle ear function, hearing situation, and quality of life, which will be measured by acoustic impedance measurement, pure-tone audiometry, and Chinese-version Chronic Ear Survey (CCES). The main analysis of change in the outcomes will use mixed-model with repeated measures (MMRM) analyses of variance (ANOVAs). Discussion This is the first prospective trial in Chinese populations that aims to validate the long-term efficacy and safety of BDET-combined TTI therapy in patients with OME. This parallel-group, single-blind, randomized controlled trial may provide an opportunity to decrease the recurrence rate of OME and explore a definitive cure for patients with OME. This trial’s rigorous design enhances the reliability of the findings, ensuring a robust answer to the research question. In the future, the research team will further expand upon the clinical evidence and applications of the BDET combined therapy. Trial registration Chinese Clinical Trial Registry ChiCTR2400079632. Registered on 8 January 2024, https://www.chictr.org.cn/bin/project/edit?pid=214452 .

Objective To prospectively evaluate the effect of tympanostomy tubes combined with adenoidectomy and tube insertion on treatment for otitis media with effusion in young children, and to analyze the related factors of prognosis and recurrence of the disease. Methods The clinical and follow-up data of 184 children with otitis media with effusion who were treated in the department of Otolaryngology, Head and Neck Surgery, Beijing Children’s Hospital, Capital Medical University from September 2013 to January 2015, were reviewed systematically. According to different surgical methods, they were randomly divided into the observation group in which patients were treated with tube insertion combined with adenoidectomy, and control group in which the rest underwent simple tube insertion. The curative effect, changes of air conduction hearing threshold before and after surgery, the healing time of tympanic membrane and recurrence of middle ear effusion were compared between the two groups. Influencing factors of recurrence of otitis media with effusion were analyzed, and the effect of healing time on tympanic membrane after tube removal was observed. Results The total effective rate of treatment in the observation group was higher than that in the control group (91.84% vs 80.23%, P  < 0.05), and the air conduction hearing thresholds in two groups were decreased significantly at 3 months and 6 months after surgery, respectively ( P  < 0.05). The total effective rate of children under 4 years old in the observation group was also higher than that in the control group. The duration of middle ear effusion and the recurrence rate in the observation group were shorter/lower than those in the control group ( P  < 0.05). Analysis showed that recurrent respiratory tract infection before surgery and retention time of ventilating tube shorter than 12 months were risk factors for recurrence of otitis media with effusion, while adenoidectomy was a protective factor. Besides, the tympanic membrane healing time of the tympanic membrane tube for 1 years was shorter than that of the tympanic membrane tube for more than one year ( P  < 0.05). The persisted perforation rate is 3.57% in less 12 months of tube, as opposed to it was 12% in more 12 months of tube ( P  < 0.05). Conclusions Tube insertion combined with adenoidectomy is more effective than tympanostomy tubes in the treatment of young children with OME, and the same results were found for children under four years of age. It can significantly shorten the duration of middle ear effusion and reduce the recurrence rate after surgery. For 3–6 year-old children, the upper respiratory tract infection and short ventilation tube indwelling time increase the possibility of OME recurrence, it is recommended that the ventilation tube should be retained for at least 12 months.

Meniere's disease, a common inner ear condition, has an incidence of 15-50 per 100,000. Because mental/physical stress and subsequent increase in the stress hormone vasopressin supposedly trigger Meniere's disease, we set a pilot study to seek new therapeutic interventions, namely management of vasopressin secretion, to treat this disease. We enrolled 297 definite Meniere's patients from 2010 to 2012 in a randomized-controlled and open-label trial, assigning Group-I (control) traditional oral medication, Group-II abundant water intake, Group-III tympanic ventilation tubes and Group-IV sleeping in darkness. Two hundred sixty-three patients completed the planned 2-year-follow-up, which included assessment of vertigo, hearing, plasma vasopressin concentrations and changes in stress/psychological factors. At 2 years, vertigo was completely controlled in 54.3% of patients in Group-I, 81.4% in Group-II, 84.1% in Group-III, and 80.0% in Group-IV (statistically I < II = III = IV). Hearing was improved in 7.1% of patients in Group-I, 35.7% in Group-II, 34.9% in Group-III, and 31.7% in Group-IV (statistically I < II = III = IV). Plasma vasopressin concentrations decreased more in Groups-II, -III, and -IV than in Groups-I (statistically I < II = III = IV), although patients' stress/psychological factors had not changed. Physicians have focused on stress management for Meniere's disease. However, avoidance of stress is unrealistic for patients who live in demanding social environments. Our findings in this pilot study suggest that interventions to decrease vasopressin secretion by abundant water intake, tympanic ventilation tubes and sleeping in darkness is feasible in treating Meniere's disease, even though these therapies did not alter reported mental/physical stress levels. ClinicalTrials.gov NCT01099046.

To correlate pre-operative computed tomography findings, intra-operative details and surgical outcomes with cholesteatoma recurrence in revision tympanomastoidectomy. This retrospective, non-randomised, single-institution cohort study included 42 patients who underwent pre-operative computed tomography imaging and revision surgery for recurrent chronic otitis media. Twelve disease localisations noted during revision surgery were correlated with pre-operative temporal bone computed tomography scans. A matched pair analysis was performed on patients with similar intra-operative findings, but without pre-operative computed tomography scans. Pre-operative computed tomography identified 25 out of 31 cholesteatoma recurrences. Computed tomography findings correlated with: recurrent cholesteatoma when attic opacification and ossicular chain involvement were present; and revision surgery type. Sinodural angle disease, posterior canal wall erosion and dehiscent dura were identified as predictors of canal wall down tympanomastoidectomy. Patients with pre-operative computed tomography scans had a higher rate of cholesteatoma recurrence, younger age at diagnosis of recurrent disease, more revision surgical procedures and less time between previous and revision surgical procedures (all p < 0.05). Pre-operative imaging and intra-operative findings have important clinical implications in revision surgery for chronic otitis media. Performing pre-operative computed tomography increases diagnosis accuracy and reduces the time required to diagnose recurrent disease.

Some studies have shown that post-tympanostomy tube otorrhea (PTTO) is a common complication after tympanostomy tube insertion. There are wide range of controversies about the incidence of PTTO and different methods of preventive treatment. The aim of this study was to determine the incidence of early PTTO in persistent otitis media with effusion in our centers. We also investigated the effect of preventive treatments on the incidence of early PTTO in children with persistent otitis media with effusion. This multi-central study comprised 536 ears belonging to children with otitis media and effusion for at least 3 months, referred for complications arising from post-tympanostomy tube insertion. The patients were randomly divided into three treatment and control groups. In the first group of patients, the middle ear cavity was irrigated with isotonic saline after myringotomy. The second group received oral amoxicillin three times a day for 7 days postoperatively. The third group had similar treatment as the second group, in addition to topical ciprofloxacin drop, 4 drops three times a day for 3 days after operation. The control group did not undergo any treatment. Early post-tympanostomy tube otorrhea was detected in 6 ears (1.1 %), including 3 (2.2 %) from the control group and 3 (2.3 %) from the first group. There was no statistically significant difference in early PTTO between integrated treatment groups and control group ( P  = 0.111). As the total rate of early post-tympanostomy tube otorrhea was very low, there was no significant difference between the 3 treatment groups and control group. Our study did not support the routine use of preventive therapy. A period of at least 3 months watchful waiting before tympanostomy tube insertion may help reduce the incidence of PTTO.

Gastroesophageal reflux (GER) is considered a cause of otitis media with effusion (OME). This study aimed to investigate whether OME can be effectively treated with a proton pump inhibitor (PPI), therefore implicating GER as a causative factor of OME. A PPI or placebo was randomly administered to enrolled subjects for 4-8 weeks. To monitor effusion status, subjects underwent monthly pneumatic otoscopy and acoustic reflectometry. At enrollment and at completion of treatment, subjects underwent an audiogram and tympanogram for assessing changes in hearing due to altered fluid levels in the middle ear. After the treatment period, tympanostomy tube placement was recommended for subjects with unresolved effusion. This study enrolled 16 patients with an average age of 5.17 years. Between the treatment and placebo groups, there was no significant difference in the need for tympanostomy tubes. At completion of this study, patients receiving Lansoprazole demonstrated a significant improvement in pure tone average (p<0.01) and speech recognition thresholds (p=0.04). Four patients (25%) from the cohort dropped out of the study. Eight patients (50%) from the cohort required tympanostomy tube placement. Owing to difficulties with recruitment and small sample size, this study was unable to demonstrate the use of PPI in treating OME. A larger study is needed for further evaluation of this process.

We conducted a prospective, observational study over a 3-year period to compare the clinical, functional, and surgical findings in children with chronic bilateral otitis media with effusion who underwent one of three different types of treatment. Our study population was made up of 150 patients-79 boys and 71 girls aged 24 to 84 months-who were randomly assigned to one of the three treatment groups of 50 patients each. One group was treated with myringotomy, tympanostomy tube insertion, and adenoidectomy (T+A group); another with a combination of physical conservative treatment and adenoidectomy (P+A group); and the third with physical conservative treatment alone (P-only group). Hearing levels and tympanogram trends were evaluated during a follow-up of 12 months. In the T+A group, we noted a stable normalization of hearing in 95 of the 100 ears. Treatment with the P+A combination resulted in an improvement of hearing in 79 ears, but the improvement was maintained in only 27 ears during 12 months of follow-up. In the group with the P-only regimen, an amelioration of hearing was registered in 76 ears, but it was unstable in all cases. A type A tympanogram was maintained during the follow-up period for 2 ears in the P+A group and for 4 ears in the P-only group. Myringotomy with a detailed examination of the tympanic cavity in all ears with prolonged abnormal audiologic results revealed that types C and B tympanograms, which were found in most ears in the P+A and P-only groups, corresponded to middle ear chronic inflammatory changes (retraction pockets, granulations, adhesions, etc.) Based on our findings, we conclude that the use of a physical conservative treatment with or without an adenoidectomy does not prevent the development of chronic adhesive and purulent otitis media.

Otitis media (OM) or middle ear inflammation is a spectrum of diseases, including acute otitis media (AOM), otitis media with effusion (OME; ‘glue ear’) and chronic suppurative otitis media (CSOM). OM is among the most common diseases in young children worldwide. Although OM may resolve spontaneously without complications, it can be associated with hearing loss and life-long sequelae. In developing countries, CSOM is a leading cause of hearing loss. OM can be of bacterial or viral origin; during ‘colds’, viruses can ascend through the Eustachian tube to the middle ear and pave the way for bacterial otopathogens that reside in the nasopharynx. Diagnosis depends on typical signs and symptoms, such as acute ear pain and bulging of the tympanic membrane (eardrum) for AOM and hearing loss for OME; diagnostic modalities include (pneumatic) otoscopy, tympanometry and audiometry. Symptomatic management of ear pain and fever is the mainstay of AOM treatment, reserving antibiotics for children with severe, persistent or recurrent infections. Management of OME largely consists of watchful waiting, with ventilation (tympanostomy) tubes primarily for children with chronic effusions and hearing loss, developmental delays or learning difficulties. The role of hearing aids to alleviate symptoms of hearing loss in the management of OME needs further study. Insertion of ventilation tubes and adenoidectomy are common operations for recurrent AOM to prevent recurrences, but their effectiveness is still debated. Despite reports of a decline in the incidence of OM over the past decade, attributed to the implementation of clinical guidelines that promote accurate diagnosis and judicious use of antibiotics and to pneumococcal conjugate vaccination, OM continues to be a leading cause for medical consultation, antibiotic prescription and surgery in high-income countries. Otitis media (OM) or middle ear inflammation is a spectrum of diseases. In this Primer, Schilder et al . provide an overview of OM epidemiology, its underlying pathophysiology, diagnosis, impact on children and their families and preventive and treatment options, as well as an outlook on the future.

Background Grommet insertion is one of the most common surgeries in childhood. While post-operative care has been traditionally provided by Ear, Nose and Throat (ENT) specialists, workforce capacity challenges have led to the delegation of care to alternate workforces, including audiology. This study aims to evaluate safety and effectiveness of audiology-led post-grommet services and to compare costs of audiology-led models with traditional medical and simulated nurse-led models. Methods A retrospective cohort study was conducted in a regional New Zealand public hospital including all 247 children attending an audiology-led post-grommet clinic from 2019 to 2025. Patient outcomes and pathways through post-grommet services were mapped and costs to the healthcare system and patient/families were calculated. Results 42.5% of children required an ENT assessment following the implementation of an audiology-led post-grommet model. At the first post-operative visit (median 184 days) 57.5% of grommets were nonfunctional. There were no adverse events reported over the six-year study period. Average healthcare system cost per patient was $NZ130.40 for the audiology-led model representing a 12% cost-savings compared to the standard ENT model ($NZ147.85). The simulated nurse-led model was more costly compared to the audiology-led and ENT models. Cost-savings for patients were achieved through salary differences and fewer clinic visits required under the audiology-led model compared to standard care. Conclusions Audiology-led post-grommet models are a clinically appropriate and cost-efficient approach to optimise service delivery in resource-limited settings.

Abstract Objective To evaluate the efficacy of adenoidectomy compared with long term chemoprophylaxis and placebo in the prevention of recurrent acute otitis media in children aged between 10 months and 2 years. Design Randomised, double blind, controlled trial. Setting Oulu University Hospital, a tertiary centre in Finland. Participants 180 children aged 10 months to 2 years with recurrent acute otitis media. Intervention Adenoidectomy, sulfafurazole (sulphisoxazole) 50 mg/kg body weight, given once a day for six months or placebo. Follow up lasted for two years, during which time all symptoms and episodes of acute otitis media were recorded. Main outcome measures Intervention failure (two episodes in two months or three in six months or persistent effusion) during follow up, number of episodes of acute otitis media, number of visits to a doctor because of any infection, and antibiotic prescriptions Number of prescriptions, and days with symptoms of respiratory infection. Results Compared with placebo, interventions failed during both the first six months and the rest of the follow up period of 24 months similarly in the adenoidectomy and chemoprophylaxis groups (at six months the differences in risk were 10% (95% confidence interval −9% to 29%) and 18% (−2% to 38%), respectively). No significant differences were observed between the groups in the numbers of episodes of acute otitis media, visits to a doctor, antibiotic prescriptions, and days with symptoms of respiratory infection. Conclusions Adenoidectomy, as the first surgical treatment of children aged 10 to 24 months with recurrent acute otitis media, is not effective in preventing further episodes. It cannot be recommended as the primary method of prophylaxis.