Does the EarPopper device improve hearing outcomes in children with persistent otitis media with effusion?

Banigo, A., Hunt, A., Rourke, T., Whiteside, O. & Aldren, C. Heatherwood and Wexham Park Hospital, Slough, SL2 4HL, UK Accepted for publication 3 June 2015 Clin. Otolaryngol. 2015, 00, 000–000

Objective: To provide an independent evaluation of the efficacy and safety of the EarPopper in improving hearing outcomes in children with otitis media with effusion (OME) and reducing the ventilation tube insertion rate.

Study Design: Randomised single-blinded controlled trial. Setting: The Ear Nose and Throat Department of a district general hospital (Heatherwood and Wexham Park).

Participants and Methods: Twenty-nine children aged between 4 and 11 years diagnosed with persistent OME lasting at least 3 months with an average hearing of 25 dBHL or worse in the better ear were randomised to a treatment or control group for 7 weeks using random computer-generated codes. Syndromic children, children with developmental delay, previous grommets and cleft palate were excluded. The audiologists were blinded at the final post-treatment audiogram.

Results: After the seven-week period, the mean improvement in air conduction across all frequencies was 10.9 dBHL in the treatment group (P < 0.001) and 3.6 dBHL in the control group (P = 0.201). At every frequency, the treatment group had larger improvements in air conduction, the largest being at 4 kHz where the mean air conduction in both ears improved by 14.8 dBHL. Compliance with the EarPopper
was over 90%, the only side-effect reported being discomfort in the ears immediately after use which resolved and did not affect compliance. The ventilation tube insertion rate was 53.3% in the treatment group and 78.6% in the control group. Median follow-up time for all patients is 47.7 months.

Conclusion: Our study shows that the EarPopper
is a safe, effective treatment option for children with hearing loss from persistent OME, and it reduces the rate of ventilation tube insertion. More studies with larger sample sizes are required to support our findings.

In the United Kingdom, the National Institute for Health and Clinical Excellence (NICE) advises initial active observation for children under 12 years old with persistent OME.1 During this period of observation, autoinflation can be considered for children likely to co-operate. Following 3 months of observation, there are only two management options for children with bilateral OME and an average air conduction of 25 dBHL or worse in the better ear: surgical with ventilation tube insertion or non-surgical with hearing aids. The guidance also states that non-surgical intervention should only be offered when surgical intervention is contraindicated or deemed not acceptable. Hearing aids unfortunately still have a certain level of negative stigmata attached to them so understandably some parents/guardians are not willing to trial them.2 The aetiology of OME is complex with several factors thought to play a role in its genesis, one being poor ability to equalise negative pressure via the Eustachian tube.3 However, it is not clear whether this impaired Eustachian tube function is a cause or an effect of OME. Regardless, the idea of improving the Eustachian tube function in a noninvasive manner via Valsalva or Politzer manoeuvres offers another potential treatment modality for OME. It is important to note that the Valsalva and Politzer manoeuvres have a small but key difference; the Valsalva manoeuvre is performed by an uncontrolled forceful attempt at expiration against a closed airway, whereas the Politzer manoeuvre is a controlled delivery of air into the nostril against a closed airway. The standardised controlled delivery of air provided by the Politzer manoeuvre makes it much more reliable and reproducible, and a preferred method for non-surgical intervention. The Otovent
balloon is an autoinflation Valsalva device, and a review showed no significant changes in pure