Due to a lack of robust evidence, we are uncertain whether autoinflation has any effect on hearing. Using autoinflation two to three times per day may slightly reduce the number of children with OME after three months follow-up. Scores on a questionnaire that looked at quality of life for people with OME were also better for children who carried out autoinflation. However, some children may experience pain when using autoinflation.
What is OME?
Otitis media with effusion (OME, sometimes called 'glue ear') is a common condition affecting young children. Fluid collects in the middle ear, causing hearing impairment. As a result of their poor hearing, children may have behavioural difficulties and delays in their speech development.
How is OME treated?
Most of the time, OME does not need any treatment and the symptoms will get better with time. In children with persistent OME, different treatments have been explored, including medications or surgery. Autoinflation is a technique where children blow air out of their nose against a pressure device (such as a balloon). This forces air back through the Eustachian tube, which connects the back of the nose to the middle ear. Opening of this tube may allow the middle ear fluid to drain away.
What did we want to find out?
We wanted to identify whether autoinflation was better than no treatment, medical treatment or surgical treatment for children with OME.
We also wanted to see if there were any unwanted effects associated with autoinflation.
What did we do?
We searched for studies that compared autoinflation with no treatment or other treatments in children with OME. We compared and summarised the study results, and rated our confidence in the evidence, based on factors such as study methods and sizes.
What did we find?
We found 11 studies that involved 1036 children with OME. Most of the studies were in children aged over three years old, and only lasted for up to three months. They compared autoinflation (carried out two to three times per day) with no treatment.
We are uncertain whether autoinflation has any effect on hearing, as there was very little evidence about this.
Autoinflation may slightly reduce the number of children who still have OME after three months of follow-up, and may result in an improvement in quality of life.
Children who use autoinflation may experience more ear pain than those who do not receive any treatment, but only one study assessed this, and the number of children with pain was small (4.4% compared to 1.3% in those who did not have treatment).
What are the limitations of the evidence?
We have very little information about the longer-term effects of autoinflation. A variety of different techniques and devices are available for autoinflation, and we do not know if some of these are more effective than others.
How up-to-date is this evidence?
The evidence is up-to-date to January 2023.
All the evidence we identified was of low or very low certainty, meaning that we have little confidence in the estimated effects. However, the data suggest that autoinflation may have a beneficial effect on OME-specific quality of life and persistence of OME in the short term, but the effect is uncertain for return to normal hearing and adverse effects. The potential benefits should be weighed against the inconvenience of regularly carrying out autoinflation, and the possible risk of ear pain.
Otitis media with effusion (OME) is an accumulation of fluid in the middle ear cavity, common amongst young children. The fluid may cause hearing loss. When persistent, it may lead to behavioural problems and a delay in expressive language skills. Management of OME includes watchful waiting, medical, surgical and mechanical treatment. Autoinflation is a self-administered technique, which aims to ventilate the middle ear and encourage middle ear fluid clearance by providing a positive pressure of air in the nose and nasopharynx (using a nasal balloon or other handheld device). This positive pressure (sometimes combined with simultaneous swallow) encourages opening of the Eustachian tube and may help ventilate the middle ear.
To assess the efficacy (benefits and harms) of autoinflation for the treatment of otitis media with effusion in children.
The Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 20 January 2023.
We included randomised controlled trials (RCTs) and quasi-randomised trials in children aged 6 months to 12 years with unilateral or bilateral OME. We included studies that compared autoinflation with either watchful waiting (no treatment), non-surgical treatment or ventilation tubes.
We used standard Cochrane methods. Our primary outcomes were determined following a multi-stakeholder prioritisation exercise and were: 1) hearing, 2) OME-specific quality of life and 3) pain and distress. Secondary outcomes were: 1) persistence of OME, 2) other adverse effects (including eardrum perforation), 3) compliance or adherence to treatment, 4) receptive language skills, 5) speech development, 6) cognitive development, 7) psychosocial skills, 8) listening skills, 9) generic health-related quality of life, 10) parental stress, 11) vestibular function and 12) episodes of acute otitis media. We used GRADE to assess the certainty of evidence for each outcome.
Although we included all measures of hearing assessment, the proportion of children who returned to normal hearing was our preferred method to assess hearing, due to challenges in interpreting the results of mean hearing thresholds.
We identified 11 completed studies that met our inclusion criteria (1036 participants). The majority of studies included children aged between 3 and 11 years. Most were carried out in Europe or North America, and they were conducted in both hospital and community settings. All compared autoinflation (using a variety of different methods and devices) to no treatment. Most studies required children to carry out autoinflation two to three times per day, for between 2 and 12 weeks. The outcomes were predominantly assessed just after the treatment phase had been completed. Here we report the effects at the longest follow-up for our main outcome measures.
Return to normal hearing
The evidence was very uncertain regarding the effect of autoinflation on the return to normal hearing. The longest duration of follow-up was 11 weeks. At this time point, the risk ratio was 2.67 in favour of autoinflation (95% confidence interval (CI) 1.73 to 4.12; 85% versus 32%; number needed to treat to benefit (NNTB) 2; 1 study, 94 participants), but the certainty of the evidence was very low.
Disease-specific quality of life
Autoinflation may result in a moderate improvement in quality of life (related to otitis media) after short-term follow-up. One study assessed quality of life using the Otitis Media Questionnaire-14 (OMQ-14) at three months of follow-up. Results were reported as the number of standard deviations above or below zero difference, with a range from -3 (better) to +3 (worse). The mean difference was -0.42 lower (better) for those who received autoinflation (95% CI -0.62 to -0.22; 1 study, 247 participants; low-certainty evidence; the authors report a change of 0.3 as clinically meaningful).
Pain and distress caused by the procedure
Autoinflation may result in an increased risk of ear pain, but the evidence was very uncertain. One study assessed this outcome, and identified a risk ratio of 3.50 for otalgia in those who received autoinflation, although the overall occurrence of pain was low (95% CI 0.74 to 16.59; 4.4% versus 1.3%; number needed to treat to harm (NNTH) 32; 1 study, 320 participants; very low-certainty evidence).
Persistence of OME
The evidence suggests that autoinflation may slightly reduce the persistence of OME at three months. Four studies were included, and the risk ratio for persistence of OME was 0.88 for those receiving autoinflation (95% CI 0.80 to 0.97; 4 studies, 483 participants; absolute reduction of 89 people per 1000 with persistent OME; NNTB 12; low-certainty evidence).