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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 .

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.

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.

Appropriate treatment of acute uncomplicated otorrhea in children with tympanostomy tubes is unclear. In this trial involving 230 children in the Netherlands, antibiotic–glucocorticoid eardrops were superior to oral amoxicillin–clavulanate or initial observation. The insertion of tympanostomy tubes is one of the most frequently performed surgical procedures in children. 1 The main indications for this procedure are the restoration of hearing in children with persistent otitis media with effusion and the prevention of recurrences in children who have recurrent acute otitis media. 2 Acute otorrhea is a common sequela in children with tympanostomy tubes, with reported incidence rates ranging from 26% in a meta-analysis of mainly observational studies (involving cases of clinically manifested otorrhea) to 75% in a randomized trial (which included asymptomatic and subclinical cases). 3 – 5 Acute tympanostomy-tube otorrhea may be accompanied by foul . . .

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.

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 assess the effect on hearing of non-functioning ventilation tubes due to blockage during the first six months post-operatively, using UK national guidelines. A prospective, observational study was conducted on 37 children who underwent bilateral ventilation tube insertion. Air and bone conduction thresholds were measured before and following surgery, and at one, three and six months post-operatively. Tube non-function was assessed by tympanometry supported by otoscopy. Post-operatively, an average of 21 per cent of ventilation tubes were non-functioning. Ears with non-functioning tubes had significantly (p = 0.0001) poorer mean air conduction thresholds than functioning tubes, with a magnitude of 6 dB HL. Ears with otorrhoea were most affected (15 per cent). At any one visit, the air-bone gap was closed to 10 dB or less in 76 per cent of ears. Non-functioning tubes reduced this to 56 per cent. Compared with tympanometry, otoscopy underdiagnosed tube non-function due to blockage by 22 per cent. Non-functioning of ventilation tubes occurs frequently and can be missed on otoscopy. Although it is associated with poorer air conduction thresholds, the magnitude of this difference is unlikely to warrant further intervention unless there is otorrhoea or recurrence of bilateral hearing impairment.

ObjectiveRate of learning is often cited as a deterrent in the use of endoscopic ear surgery. This study investigated the learning curves of novice surgeons performing simulated ear surgery using either an endoscope or a microscope.MethodsA prospective multi-site clinical research study was conducted. Seventy-two medical students were randomly allocated to the endoscope or microscope group, and performed 10 myringotomy and ventilation tube insertions. Trial times were used to produce learning curves. From these, slope (learning rate) and asymptote (optimal proficiency) were ascertained.ResultsThere was no significant difference between the learning curves (p = 0.41). The learning rate value was 68.62 for the microscope group and 78.71 for the endoscope group. The optimal proficiency (seconds) was 32.83 for the microscope group and 27.87 for the endoscope group.ConclusionThe absence of a significant difference shows that the learning rates of each technique are statistically indistinguishable. This suggests that surgeons are not justified when citing ‘steep learning curve’ in arguments against the use of endoscopes in middle-ear surgery.

Background The prevalence of otitis media in Greenlandic children is one of the highest in the world. International studies have shown that otitis-prone children may benefit from tubulation of the tympanic membrane. However, it is unknown whether these results can be applied to Greenlandic children and trials on the effects of ventilation tubes in high-risk populations have, to our knowledge, never been conducted. Methods The trial is an investigator-initiated, multicentre, randomized, blinded superiority trial of bilateral ventilation tube insertion versus treatment as usual (no tube) in Greenlandic children aged 9–36 months with chronic otitis media with effusion or recurrent acute otitis media. With randomization stratified by otitis media subtype and trial site, a type 1 error of 5% and a power of 80%, a total of 230 participants are needed to detect a decrease of two visits to a health clinic during 2 years, which is considered the minimal clinical relevant difference. The primary outcome measure will be assessed blindly by investigating medical records. Secondary outcome measures are number of episodes of acute otitis media, quality of life, number of episodes of antibiotics administration and proportion of children with tympanic membrane perforations. Discussion This trial will provide evidence-based knowledge of the effects of ventilation tubes in children with middle ear infections from the high-risk Greenlandic population. Furthermore, this trial will improve the understanding of conducting randomized clinical trials in remote areas, where management of logistical aspects is particularly challenging. Trial registration ClinicalTrials.gov, NCT02490332 . Registered on 14 February 2016.

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.