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The prevalence of pediatric tympanostomy tube placement (TTP) in the United States has not been reassessed in the past decade. To assess the prevalence of TTP and frequent ear infections (FEI), the National Health Interview Survey for the calendar year 2014 was used. Among 73.1 million children, 6.26 million (8.6%) had TTP. The incidence of FEI was 3.49 million (4.8%). Males (9.6%) were more likely than females (7.5%) to undergo TTP (P = .004). Among children under 2 years of age, 9.1% reported FEI, compared to 3.9% of children aged 3 to 17 years. Among children under 2 years of age, 25% with FEI received TTP vs 1.5% without FEI (P < .001). Among children aged 3 to 17 years, 31.1% with FEI received TTP vs 8.6% without FEI (P < .001). TTP may be increasing nationally, although further assessment of adherence to clinical practice guidelines is needed to investigate this potential trend. [ABSTRACT FROM AUTHOR]

Fully implantable hearing devices (FIHDs) have been developed as a new technology to overcome the disadvantages of conventional acoustic hearing aids. The implantable microphones currently used in FIHDs, however, have difficulty achieving high sensitivity to environmental sounds, low sensitivity to body noise, and ease of implantation. In general, implantable microphones may be placed under the skin in the temporal bone region of the skull. In this situation, body noise picked up during mastication and touching can be significant, and the layer of skin and hair can both attenuate and distort sounds. The new approach presently proposed is a microphone implanted at the tympanic membrane. This method increases the microphone’s sensitivity by utilizing the pinna’s directionally dependent sound collection capabilities and the natural resonances of the ear canal. The sensitivity and insertion loss of this microphone were measured in human cadaveric specimens in the 0.1 to 16 kHz frequency range. In addition, the maximum stable gain due to feedback between the trans-tympanic microphone and a round-window-drive transducer, was measured. The results confirmed in situ high-performance capabilities of the proposed trans-tympanic microphone.

Objectives: Middle ear barotrauma is a common complication of hyperbaric oxygen therapy (HBOT). Tympanostomy tube placement prevents barotrauma by facilitating middle ear equalization. We describe variations on techniques published by Mooney et al and Zhang et al for placing modified peripheral intravenous cannula (PIVC) ventilation tubes, which can be performed at the bedside under topical anesthesia. We aim to evaluate the safety and efficacy of this technique when performed to prevent otic barotrauma in patients undergoing HBOT. Methods: We performed an analytical observational study at a tertiary metropolitan Australian hospital with a state-wide adult hyperbaric service between 2018 and 2022. Patients were identified via unit audits. Patient, HBOT, and procedural factors were analyzed against complications using Fisher's exact test with Bonferroni correction and simple logistic regression. Results: Over 4 years, 112 patients (220 ears) underwent modified PIVC ventilation tube insertion. Mean age was 58.6 years (95% CI: 55.7-61.6, SD: 15.9). Thirty-eight patients (33.9%) were female, 74 (66.1%) were male. Thirty-four ears (15.5%) had preexisting barotrauma at the time of tympanostomy tube insertion. Patients underwent a mean of 11.5 dives (95% CI: 9.0-14.0, SD: 13.4), with ventilation tubes being required for a mean of 15.0 days (95% CI: 9.0-14.0, SD: 24.0) to complete HBOT. Fourteen ventilation tubes (6.4%) developed blockage during HBOT, and 12 (5.5%) prematurely extruded. Sixteen ears (7.3%) required reinsertion of ventilation tubes. Nine ears (4.1%) suffered barotrauma despite ventilation tube insertion. Conclusions: Otic barotrauma prophylaxis is paramount for safety during HBOT. We describe a safe, effective, and convenient technique for barotrauma prevention using modified PIVCs., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

OBJECTIVE: To investigate the eustachian tube (ET) function (ETF) in adults with ventilation tube (VT) inserted for the treatment of chronic otitis media with effusion (COME). MATERIALS and METHODS: A total of 17 subjects with at least one VT were enrolled. A detailed history was obtained, and risk factors were assessed with questionnaires. Examination including nasopharyngeal video endoscopy and ETF tests, the forced response test (FRT), inflation- deflation test (IDT), and nasal/nasopharyngeal maneuvers (such as sniffing and Valsalva, Toynbee, and the diver's maneuvers) were performed. RESULTS: Averages for FRT were 580±333 daPa, 382±251 daPa, and 138±192 daPa for opening pressure, steady-state pressure, and closing pressure, respectively. Most subjects demonstrated minimal or weak active function during the FRT and IDT. While nasopharyngeal maneuvers changed the nasal/nasopharyngeal pressures, they did not significantly change the middle-ear pressures. These results indicated that most subjects had severe obstructive ET dysfunction (ETD) with an ET lumen that required high pressure differences to open and poor active muscular function inadequate for luminal dilation. These results imply that while any treatment to widen the ET, such as balloon dilation of the ET, is not expected to change the voluntary active muscular function, it may reduce the tissue pressures and resistance, thus facilitating luminal opening both passively and actively. CONCLUSION: Most patients with VT inserted for the treatment of COME appear to have an abnormal ETF with difficulty in passively opening the ET and weak active muscular function. Management of such patients addressing only passive properties may not be sufficient for the resolution of ETD. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the histopathologic changes in tympanic membranes (TMs) with ventilation tubes (VTs).Methods: In this retrospective human temporal bone study our overall study group included 4 subgroups of TMs from deceased donors as follows: 24 with a history of VT insertion for chronic otitis media with effusion (COME-VT); 5 with a history of VT insertion for Meniere's disease (MD-VT); 33 without a history of VT insertion for chronic otitis media with effusion (COME); and 14 without a history of VT insertion for Meniere's disease (MD). We classified the extent of migration of the outer keratinized squamous epithelium onto the inner surface of TM perforations and noted the presence and location of tympanosclerosis, of atrophy, of perforation, and/or of cholesteatoma formation.Results: Tympanosclerosis occurred in 14/24 TMs in the COME-VT subgroup; 2/5, MD-VT; 7/33, COME; and 0/14, MD. The VT insertion site was mostly in the anteroinferior (63%) quadrant of the TM; tympanosclerosis occurred more frequently in the posteroinferior (42%) and posterosuperior (33%) quadrants. We found no significant correlation between the location of tympanosclerosis and the VT insertion site (P>0.05). Atrophy occurred in 7/24 TMs in the COME-VT subgroup; 3/5, MD-VT; 8/33, COME; and 2/14, MD. We found no significant correlation between the location of atrophy and the VT insertion site; however, atrophy was located mostly in the anteroinferior quadrant (one of the most common VT insertion sites) of the TM. Regarding the ingrowth of keratinized epithelium, the mucocutanous junction was detected at any point at the inner surface of the TM in 50% of the specimens. We observed intratympanic cholesteatoma formation in 2/24 TMs in the COME-VT subgroup.Conclusion: TM changes due to VT insertion are more common than previously realized. Meticulous otomicroscopic evaluation of the TM is necessary during tympanomastoidectomies in order to prevent the intratympanic inclusion pearls and squamous epithelial ingrowth to prevent any further cholesteatoma formation. [ABSTRACT FROM AUTHOR]

Objectives: To determine whether children with cleft palate might benefit from early long-term tympanostomy tubes with the hypothesis that receiving multiple tubes is associated with shorter duration of first tubes. Design: Retrospective cohort study. Setting: Tertiary care children’s hospital. Participants: Records from 401 consecutive children with cleft palate ± cleft lip, born April 2005 to April 2010, were reviewed. After exclusion of children with cleft repair at an outside hospital, no follow-up after 5 years of age, intact secondary palate, no tubes, or tube replacement at palatoplasty, 105 children remained. Main Outcome Measure: Number of tubes. Results: Armstrong grommet tubes were placed at a median age of 6.7 months (range 2.3-19.6 months). Tubes were replaced in 55.3% of patients, with 34.0% receiving ≥3 sets. Duration of first tubes was significantly longer for children with 1 set of tubes compared with those with multiple sets (median 26 vs 19 months, P = .004). Otorrhea, but not perforation, was associated with longer duration of first tubes (median 27 vs 20.5 months, P = .028). Cleft type did not impact the proportion of patients with multiple tubes. Median age at last tube placement for children with multiple tubes was 5.0 years (range 1.9-8.7 years). Conclusion: Short duration of first tubes is associated with receiving multiple tubes. Because most patients require repeat tubes and many require tubes until school age, there is a significant need for controlled, prospective trials of early long-term tube placement in this population. [ABSTRACT FROM AUTHOR]

Objective: The purpose of this study was to assess the effect of ventilation tube (VT) placement on long-term hearing outcomes in children with cleft palate. Study Design: Case series with chart review. Setting: Genetic and dysmorphology database at Rady Children’s Hospital–San Diego (RCHSD). Patients: Children with cleft palate diagnosis who underwent surgery at RCHSD between 1995 and 2002. Main Outcome Measure: The primary outcome studied was hearing acuity at 10 years of age. Independent variables studied included gender, age at palate repair and first VT placement, total number of VTs, number of complications, and presence of tympanic membrane perforation. Results: An increased number of tubes was associated with a greater incidence of hearing loss at age 10, even after adjusting for total number of otologic complications. The timing of initial tube placement did not have a significant effect on long-term hearing outcome in this study. Conclusions: While children with worse middle ear disease are more likely to receive more tubes and have long-term conductive hearing loss as a result of ear disease, the results of this study suggest that multiple tube placements may not contribute to improved long-term hearing outcomes. Further research focusing on long-term outcomes is needed to establish patientcentered criteria guiding decision making for ventilation tube placement in children with cleft palate. [ABSTRACT FROM AUTHOR]

To compare the effectiveness of myringotomy and ventilation tube insertion versus observation in post-radiation otitis media with effusion (OME) in nasopharyngeal carcinoma (NPC). NPC patients who finished radiotherapy and had persistent OME were randomized to myringotomy and ventilation tube insertion and observation groups. The resolution rate of OME and hearing outcomes were evaluated. Forty three patients (23 in control group and 20 in intervention group) were analyzed. One patient in the control group obtained a resolution of OME. The remaining patients in the control group had persistent middle ear fluid. Fourteen patients in the intervention group had retained ventilation tubes without otorrhea. Ventilation tubes had spontaneously extruded in the remaining six patients and all of these patients had recurrent OME. Mean air-pure tone average in the control group was 52.04 dB (SD 11.61), significantly different from the intervention group [38.15 dB (SD 19.10); p = 0.01]. Mean air-bone gap in the control and intervention groups were 27.30 dB (SD 9.11) and 9.30 dB (SD 9.59) respectively ( p < 0.001). Mean air-pure tone average and mean air-bone gap improvement was significantly improved in the intervention group ( p < 0.001). Two patients in the intervention group (10%) developed complications, one patient suffering suppurative otitis media whilst another had otorrhea, which resolved after 1-week course of antibiotic treatment. Post-radiation OME is common in patients with NPC and tends to persist long-term. Conservative management is safe, however, is plagued by frustrating effects of hearing impairment and aural fullness. Myringotomy with ventilation tube insertion leads to hearing improvement with few complications. [ABSTRACT FROM AUTHOR]

Background: Otitis media with effusion (OME) is a collection of non-purulent fluid in the middle ear space; it is almost universal in children with cleft palate. Cleft palate (CP) is among the most common congenital malformations, with an overall incidence of around 1 in 700 individuals. Surgical closure of the cleft palate may lead to improvement in the audiological status of the patients, but whether early surgical correction can improve the middle ear status in CP children remains open for debate. Aim: A meta-analytical study to evaluate and compare the outcome of ventilation tube insertion versus conservative management in management of otitis media with effusion accompanying cleft palate. Methods: A review process was used to assess eligible studies drawn from included published medical articles about conservative management versus ventilation tube insertion in children with otitis media with effusion accompanying cleft palate through searching the Medline data base (www.pubmed.com) and Cochrane library. Then Data were extracted and analyzed from the included studies. Results: 30 relevant articles were found, by application of inclusion criteria 8 articles were found meeting the inclusion criteria and could undergo Meta-analysis. Our results have shown that OME in children with repaired cleft palate can be managed satisfactorily without routine use of ventilation tube (VT). The presence of OME does not lead to long term complications in all patients. Hearing impairment due to OME can be satisfactorily treated with hearing aid (HA) in a majority of children. VT need to be inserted only if the child is not compliant with using a HA or develops recurrent suppurative otitis media. Patients should be followedup closely for OME to prevent complications. Conclusion: Routine use of ventilation tube in CP patients should be discouraged; instead Treatment should be based on the need and willingness of the children and their parents. Also with respect to individual bases such when the child is proved to have OME and hearing loss that affect child language and speech development. Insertion of ventilation tubes should be offered as an alternative to hearing aids or conservative management by close otological and audiological follow up. [ABSTRACT FROM AUTHOR]

Objective: To identify eventual correlations between the effect of low-pressure treatment and endolymphatic hydrops in Ménière patients.Material and Methods: The study group consisted of subjects affected by definite Ménière disease (2015) and a severe degree of disability, who received a ventilation tube with or without a low-pressure treatment before undergoing a surgical procedure (vestibular neurectomy). After the placement of the ventilation tube, the subjects were either left alone with the tube or received 1 month of self-administered low-pressure therapy with a portable device. In all subjects, an electrocochleography (ECochG) was performed and specific questionnaires - Dizziness Handicap Inventory (DHI) and Functional Scale Level (FSL) - were completed before starting either arm of treatment, at the end of treatment, and then 3 and 6 months later.Results: All selected subjects presented with an ECochG pattern that was indicative of endolymphatic hydrops before starting either treatment. At the end of pressure treatment, 80% showed symptomatic improvement while maintaining the hydropic ECochG pattern. At the 3-month control stage, the hydropic pattern resulted normalized (<0.5) in all the improved subjects.Conclusions: Although 1 month of low-pressure treatment provided a positive symptomatological outcome, normalization of the hydropic ECochG parameters occurred only at a later time. Therefore, it is possible to assume that endolymphatic hydrops could be concurrent with a non-symptomatic stage of Ménière disease, and that the anti-hydropic effect of the low-pressure treatment, if any, would present with a certain delay after its completion. [ABSTRACT FROM AUTHOR]

Objective Children with cleft lip and palate have a high prevalence of otitis media with effusion (OME) which is often associated with a fluctuating, conductive hearing loss in the low and mid-frequencies and a risk for permanent hearing loss in the higher frequencies. Although common, there is no consensus on the treatment of OME with ventilation tubes. The aim of this study is to document if the risk for permanent hearing loss and acquired cholesteatoma increases due to treatment with ventilation tubes (VT treatments) during childhood in a group of children with cleft lip and palate. Methods A retrospective medical chart review of 33 children (25 boys and 8 girls) born with unilateral cleft lip and palate (UCLP) was completed. Audiological data (results of hearing sensitivity tests, the total number of hearing tests, and number of VT treatments) were extracted from medical records from when the children were 4–7 and >7–10 years of age. Results The hearing thresholds in the speech frequencies improved with age (p < 0,05) but a minority of the children continued to present with elevated hearing thresholds in the higher frequencies at >7–10 years of age. There were no significant correlations between number of VT treatments and hearing thresholds at >7–10 years. Four of the 33 children presented with complications: two children exhibited perforations of the ear drum (6.1%) and two children developed unilateral cholesteatoma (6.1%). Conclusion In the current study, the hearing sensitivity of children with cleft lip and palate improved with age. However, this improvement was not seen in the higher frequencies. Twelve percent of the children experienced complications following VT treatments. Due to these complications, it is recommended that all children with cleft palate should have routine follow-ups by an ENT doctor and audiologist. As part of the routine follow-up care, hearing assessments should be performed before and after VT treatments. [ABSTRACT FROM AUTHOR]

This study aims to determine the number of patients with cleft palate requiring treatment for otitis media with eff usion. Speech and hearing assessments were also considered. We conducted a retrospective study from January, 2005 through December, 2012 at King Abdulaziz University Hospital, Jeddah, Saudi Arabia, on otitis media with eff usion in patients with cleft palate. We reviewed patients’ medical records to determine the number requiring treatment for otitis media with eff usion, the timing of middle ear ventilation tube insertion, the number of tubes to be inserted, and the type of tube to be used. Data were collected from the patients’ medical records. Ethical approval was obtained by the university’s ethical committee. A total of 101 patients were diagnosed with cleft palate spectrum. Among them, we found that only 12 patients had a hearing assessment and tympanograms performed followed by middle ear ventilation tube insertion. This may indicate the need for more involvement of the otolaryngologists in the multidisciplinary clinical teams for evaluating cleft palate patients . [ABSTRACT FROM AUTHOR]

Objective To evaluate histologically the progressive development and underlying mechanisms of chronic tympanic membrane perforation (TMP) in a rat model using a two-weeks ventilation tube (VT) treatment combined with topical application of mitomycin C/dexamethasone (VT-M/D), compared with normal tympanic membrane and acute TMPs. Methods Fifty male Sprague-Dawley rats were divided into three experimental groups: a normal control group (n = 5), an acute TMP group (n = 5) (i.e. 3 days post-myringotomy) and a VT-M/D group (n = 40). The TMs were regularly assessed by otoscopy. The normal control animals were sacrificed on day 0 and the acute TMP group was sacrificed 3 days post-myringotomy for histological and immunohistochemical evaluations. The VT-M/D group was sacrificed at various time points - 14 and 17 days, 3, 4, 6, 8 and 10 weeks. Results On longitudinal histological examination, compared with normal TM and acute TMP, the perforation edges at the later time points illustrated thickened stratified squamous epithelium rimming around the edges, significant increase in keratin and collagen deposition, increased macrophage infiltration as well as reduced cellular proliferation. Three phases of TMP healing process were identified - the acute healing phase (3–17 days), the transition phase (3–4 weeks) and the chronic phase (6–10 weeks). Conclusion Based on the histological results of this study, the progressive development of chronic TMPs appeared to be associated with increased epidermal thickening, collagen and keratin deposition, macrophage infiltration and reduced cellular proliferation. After the 3–4 weeks of transition phase, the TMPs seemed to have transformed into a non-healing chronic TMP between 6 and 10 weeks. [ABSTRACT FROM AUTHOR]

Background and Objective: Acquired cholesteatomas behind intact tympanic membrane (ITMC) are rarely encountered in adults in the otology clinic, and the clinical and imaging features of ITMC in adults remain unclear to date. ITMC patients are commonly overlooked because of the absence of both a typical retraction pocket and a tympanic membrane (TM) perforation. The objective of this study was to describe clinical features, pathogenesis, and surgical outcomes in a series of adult patients with acquired ITMC. Materials and Methods: The clinical records of 13 adult patients diagnosed with ITMC were retrospectively reviewed. ITMC were classified into those associated with otitis media with effusion (OME; Group A) and histories of previous perforations (Group B). Results: A total of 13 cases with unilaterally acquired ITMC were included, of which 10 (76.9%) were in Group A and 3 (23.1%) were in Group B. All Group A patients exhibited white masses behind intact TMs, in the anterosuperior quadrants of 6 and the posterior upper quadrants of 4. In Group B patients, white masses in the middle ear were lacking. The TMs were atrophic and white myringosclerotic plaques were evident. The cholesteatomas were confined to the antrum and aditus ad antrum in 2 Group B patients but extended to the epitympanum in 1. All 10 Group A patients had extensive cholesteatomas but intact (noneroded) malleoli. Conclusions: An acquired ITMC should be suspected if symptoms worsen or new symptoms develop in adults with OME or a history of perforation, although the TM is intact with or without pars flaccida retraction, computed tomography/magnetic resonance imaging should be performed. Canal wall up mastoidectomy combined with ventilation tube insertion effectively treated ITMC associated with OME., Competing Interests: Declaration of Conflicting InterestsThe author declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

The objective was to determine the range of hearing improvement (in dB) post ventilation tube insertion in children with chronic otitis media with effusion (COME), and whether there was a difference in hearing improvement between age groups and genders. This study also investigated whether there was a difference in the mean hearing improvement between the left and right ear, how many months passed before recovery of eustachian tube function, and how long the aeration of the middle ear lasted. The children included in the study were between six and twelve years of age, diagnosed with COME by audiological processing (type B tympanometric recording and conductive hearing loss up to 40 dB on pure tone audiometry) and underwent surgical insertion of ventilation tubes in both ears. Patient data included preoperative tympanometric records, preoperative and postoperative tone audiometry findings, tubometry findings 6 and 10 months after insertion of ventilation tubes, age and gender data, and length of time during which the tubes were in place. The mean hearing improvement of the included patients was 24.2 dB on the right ear and 24.5 dB on the left ear. There was no statistically significant difference between the left and right ear or between the genders. Older age groups had a higher mean hearing improvement compared with the younger age group. Younger age groups had a longer expected period of eustachian tube function recovery, and were expected to have ventilation tubes inserted for a longer period of time. Treatment with ventilation tube insertion resulted in significant improvement in hearing in children where previous conservative therapy failed to recover eustachian tube function and improve hearing. Although children of older age groups had greater preoperative hearing impairment, the recovery of both eustachian tube function and hearing improvement was faster, and the mean length of time that the ventilation tubes had to be inserted was shorter., (Sestre Milosrdnice University Hospital.)

ObjectivesThe objective of this study was to determine the various factors that affect the extrusion rate of ventilation tubes (VTs), including the nature of the middle ear effusion.MethodsA retrospective chart review of 82 pediatric patients (177 ears) who received VT insertion surgery under general anesthesia was carried out to evaluate the relationship between various factors and the VT extrusion rate. The factors we analyzed included age, gender, the adenoid size, the amount and content of the middle ear effusion after myringotomy, bleeding events, associated adenoidectomy and the findings of the tympanic membrane status, the tympanometry and the audiometry of the air bone gap.ResultsThe mean extrusion time was 254 days (range, 11 to 809 days). The patients with no history of previous VT insertion had a longer extrusion time (mean, 279 days) than did the patients who had undergone previous VT insertion (mean, 203 days). The patients with serous effusion had the shortest extrusion time (mean, 190 days) as compared to those patients with glue (273 days) and pus (295 days) effusions. Other factors had no statistical significant relationship with the extrusion time.ConclusionThe mean VT extrusion time was 254 days. The VT extrusion time was significantly related to the characteristics of the middle ear effusion and a history of previous VT insertion. Thus, the nature of middle ear effusion can provide a clinical clue to predict the VT extrusion time.

Background and Objective: The aim of this study was to investigate the factors affecting extrusion time in both children and adults with ventilation tube (VT) insertion, providing useful information for clinicians for better decision-making, follow strategy, and potentially improve clinical outcomes for these patients., Methods: Data from patients receiving myringotomy with VT insertion from January 1, 2007, to June 30, 2012, were retrospectively collected and analyzed by the end of 2018. Various factors, including age, gender, history of VT insertion, tympanogram, size of VT used, local finding of tympanic membrane, hypertension, diabetes mellitus, hyperlipidemia, and postoperative ear infection, were included and analyzed to examine the effects of these factors on extrusion time., Results: A total of 447 patients were included in this study (Child group-Adult group = 237:210). The overall average extrusion time was 225.85 days. In the subgroup analysis, the average time was 221.3 days and 231.0 days for children and adults, respectively. The results showed that the VT extrusion time was significantly longer in participants without a history of VT insertion and in those where larger sized VTs were inserted in both age-groups. Male gender had an influence on extrusion time in children. In addition, a history of VT insertion and VT size were determined to be factors related to extrusion before 12 months in children., Conclusion: History of VT insertion and VT size were significantly related to VT extrusion time in both children and adults and defined as factors associated with extrusion before 12 months in children. The findings suggest avoiding VT with a diameter < 1 mm and considering an appropriately larger size in patients with a history of VT insertion to optimize VT retention.

Background: Cleft lip and palate are among the most common congenital malformations, with an incidence of around 1 in 700. Cleft palate (CP) results in impaired Eustachian tube function, and 90% of children with CP have otitis media with effusion (OME) histories. There are several approaches to management, including watchful waiting, the provision of hearing aids (HAs) and the insertion of ventilation tubes (VTs). However, the evidence underpinning these strategies is unclear and there is a need to determine which treatment is the most appropriate. Objectives: To identify the optimum study design, increase understanding of the impact of OME, determine the value of future research and develop a core outcome set (COS) for use in future studies. Design: The management of Otitis Media with Effusion in children with cleft palate (mOMEnt) study had four key components: (i) a survey evaluation of current clinical practice in each cleft centre; (ii) economic modelling and value of information (VOI) analysis to determine if the extent of existing decision uncertainty justifies the cost of further research; (iii) qualitative research to capture patient and parent opinion regarding willingness to participate in a trial and important outcomes; and (iv) the development of a COS for use in future effectiveness trials of OME in children with CP. Setting: The survey was carried out by e-mail with cleft centres. The qualitative research interviews took place in patients’ homes. The COS was developed with health professionals and parents using a web-based Delphi exercise and a consensus meeting. Participants: Clinicians working in the UK cleft centres, and parents and patients affected by CP and identified through two cleft clinics in the UK, or through the Cleft Lip and Palate Association. Results: The clinician survey revealed that care was predominantly delivered via a ‘hub-and-spoke’ model; there was some uncertainty about treatment strategies; it is not current practice to insert VTs at the time of palate repair; centres were in a position to take part in a future study; and the response rate to the survey was not good, representing a potential concern about future co-operation. A COS reflecting the opinions of clinicians and parents was developed, which included nine core outcomes important to both health-care professionals and parents. The qualitative research suggested that a trial would have a 25% recruitment rate, and although hearing was a key outcome, this was likely to be due to its psychosocial consequences. The VOI analysis suggested that the current uncertainty justified the costs of future research. Conclusions: There exists significant uncertainty regarding the best management strategy for persistent OME in children with clefts, reflecting a lack of high-quality evidence regarding the effectiveness of individual treatments. It is feasible, cost-effective and of significance to clinicians and parents to undertake a trial examining the effectiveness of VTs and HAs for children with CP. However, in view of concerns about recruitment rate and engagement with the clinicians, we recommend that a trial with an internal pilot is considered. Funding: The National Institute for Health Research Health Technology Assessment programme. This study was part-funded by the Healing Foundation supported by the Vocational Training Charitable Trust who funded trial staff including the study co-ordinator, information systems developer, study statistician, administrator and supervisory staff.

Objectives: The effect of delayed ventilation tube insertion in children concerning linguistic, speech and cognitive development with otitis media with effusion (OME) were examined in this study.Methods: Randomized controlled trial. Wechsler Intelligence Scale for Children - Revised and Peabody Picture Vocabulary Tests were applied two groups of children. Study group consists of the children with OME who had ventilation tube insertion delayed for nine or more months control group with OME who had ventilation tube insertion before nine months.Results: Significant statistical difference have been found out between these two groups in the parameters such as total intelligence, verbal intelligence, receptive language, general information, comprehension, arithmetic, similarity, vocabulary, picture completion and picture arrangement. The control group has been found more successful in these tests according to the group with children who had OME surgery after nine months. However, in the parameters of design with cubes, coding and object assembling, no significant difference has been found out between the two groups.Conclusion: Delayed tube insertion in OME has a permanent negative effect on children’s articulation, linguistic and cognitive development. For this reason, following OME diagnosis, hearing loss in children should be followed at regular intervals by audiological tests and if hearing loss is not improving for more than nine months ventilation tube should be inserted immediately.

Otitis media with effusion (OME) is the most frequent illness in children. Surgical treatment options include ventilation tube insertion, adenoidectomy or both. Opinions regarding the risks, benefits and intubation period of ventilation tube insertion vary greatly. To determine the appropriate time for when to remove asymptomatic longterm ventilation T-tubes in children. In this prospective study, we analyzed the results of 120 pediatric patients (6-12 years) (240 ears) with persistent OME; we employed the Goode T-silicone tubes. We intentionally planned to remove the tubes at different time points of the study and divided our patients randomly into four subgroups with 30 patents (60 ears in each) according to the intubation period; group I: intubation for 6 months, group II: intubation for 12 months, group III: intubation for 18 months and group IV: intubation for 24 months. The relationship between intubation period and OME recurrence, the rate of persistent tympanic membrane (TM) perforation, granulation tissue or discharge near the tympanostomy tubes, normalization of Eustachian tube function and change of hearing level was analyzed in each patient group. The χ analysis showed that the rate of normalization of ET function was significantly higher when tubes were removed after 12-months of intubation (P = 0.002), the rate of OME recurrence was significantly higher when tubes were removed before 12-months of intubation (P = 0.004), The rate of otorrhea significantly increased after 12-months of intubation, development of granulation around tubes was significantly higher after 18-months of tube insertion. The rate of appearance of permanent TM perforation significantly increased after 18-months from tube insertion (P = 0.008). Adenoidectomy did not significantly influence the recurrence rate of OME or the rate of persistent TM peroration after tube removal. Our present results suggest that the appropriate intubation period for healing OME in children would be at 12-18 months. Also, we can conclude that longterm ventilation tubes are recommended to avoid repeated intubation and to obtain sufficient results, although their performance is not always satisfactory; mainly because of accompanying complications. [ABSTRACT FROM AUTHOR]

Objectives The objectives of this study was to determine variables associated with rVT insertions for rAOM and/or OME in otherwise healthy children. Methods This was designed as a retrospectively controlled cohort study. Patients were identified from a prospectively collected surgical database. Eligible subjects were those who had undergone rVT and a consecutive concurrent control group who received only one ventilation tube (VT). Exclusion criteria included craniofacial abnormalities and syndromes. Demographics, tympanic membrane characteristics, parental smoking, breast-feeding history, large day-care attendance, and soother use was collected. Results Over a period of 10 years, 59 patients underwent rVT (5.6%). 180 children who underwent VT were included in the control group. There was no difference in gender distribution ( p = 1, 1.73:1 vs. 1.76:1), mean age ( p = 0.69, 4.7 ± 3.33 vs. 4.4 ± 3.17) or chronic rhinitis ( p = 0.36, OR 1.376, 95% CI: 0.69–2.74). The rVT group was associated significantly more with a smoking parent ( p = 0, OR 61.8, 95% CI 21.26–176.07), large day care attendance ( p = 0, OR 23.39, 95% CI: 8.637–57.54), breast feeding <3months ( p = 0, OR −0.074, 95% CI: 0.028–0.331), soother use ( p = 0, OR 21.49, 95% CI: 7.81–55.87), and tympanic membrane atelectasis ( p < 0.0005). The same factors were also found to be significant upon multiple regression analysis ( p < 0.05). Conclusions Otherwise healthy children with rAOM and/or OME are at a greater risk of rVT if they attend large day cares, were not breast fed for ≥3 months, if their tympanic membranes were atelectatic and most significantly if their parents smoke. [ABSTRACT FROM AUTHOR]

Background and purpose: Cleft palate is one of the most common anomaly of face and hearing loss is one of its main complications. In this study, we evaluated the status of tympanometry and the need for ventilation tube (VT) in patients with cleft palate. Materials and methods: A descriptive study (during 11 years) was done in children between one to two years of age referring for cleft palate repair. Before operation, tympanometry was performed in all patients and results were recorded in the form of standard groups A, B, and C. If the tympanogram had shown type B or C, VT was placed in tympanic membrane. The type of middle ear discharge in the form of serosa, glue or purulent were recorded. Finally, these observations were compared with the results of tympanometry and type of cleft palate. Results: A total of 48 patients entered the study, of whom 22 were boys and 26 were girls. The mean age of the subjects was 15 months. Tympanometry before surgery had shown type A in 21 ears, type B in 68 ears and type C in others. In fact, 87.5% of patients had shown at least one abnormal ear that needed VT insertion. Middle ear effusion was seen in 93.3% of cases. The effusions were viscous or purulent in 80% of the cases, and there was a significant relationship between the type of discharge and tympanometry results. Conclusion: The majority of patients with cleft palate have impaired tympanogram, therefore, insertion of VT is acceptable even without performing initial evaluation by tympanometry. [ABSTRACT FROM AUTHOR]

Objective Chronic tympanic membrane perforation (TMP) in a clinical setting may attract surgical intervention. With the advent of modern biomaterials, new options are available for myringoplasty but safety and efficacy need evaluation in a chronic TMP animal model. The aim of this study was to evaluate the efficacy of ventilation tube (VT) insertion in conjunction with topical application of mitomycin C/dexamethasone (M/D) for the creation of chronic TMP in rats. Methods Thirty male Sprague-Dawley rats underwent myringotomy of the right tympanic membrane (TM) and were divided into three experimental groups: spontaneous healing (myringotomy control), VT insertion for 2 weeks and VT insertion for 2 weeks in conjunction with topical application of M/D (VT-M/D). All TMs were regularly assessed by otoscopy for 10 weeks and then animals were sacrificed for histological evaluation. Results In the VT-M/D group, seven out of ten (70%) perforations were patent at 10 weeks (mean patency, 57.9 days; P < 0.01). The VT group had two out of ten (20%) perforations patent at 10 weeks (mean patency, 26.5 days; P < 0.01), while all TMPs from the myringotomy control group were closed by day 9 (mean patency, 7.2 days). Histologically, the TMPs patent at week 10 had a stratified squamous epithelialized rim, keratinocyte layer thickening around the perforation edge as well as increased collagen deposition and macrophage infiltration. Conclusion Chronic TMP in a rat model was successfully created by VT insertion and the efficacy was increased in combination with topical application of M/D. [ABSTRACT FROM AUTHOR]