title: Does the EarPopper(®) device improve hearing outcomes in children with persistent otitis media with effusion? A randomised single-blinded controlled trial.
abstract: 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.
  
  
  METHODS
  Randomised single-blinded controlled trial.
  
  
  METHODS
  The Ear Nose and Throat Department of a district general hospital (Heatherwood and Wexham Park).
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Heatherwood and Wexham Park Hospital, Slough, SL2 4HL, UK.
authors.forename: A
authors.initials: A
authors.lastname: Banigo
authors.affiliation: Heatherwood and Wexham Park Hospital, Slough, SL2 4HL, UK.
authors.forename: A
authors.initials: A
authors.lastname: Hunt
authors.affiliation: Heatherwood and Wexham Park Hospital, Slough, SL2 4HL, UK.
authors.forename: T
authors.initials: T
authors.lastname: Rourke
authors.affiliation: Heatherwood and Wexham Park Hospital, Slough, SL2 4HL, UK.
authors.forename: O
authors.initials: O
authors.lastname: Whiteside
authors.affiliation: Heatherwood and Wexham Park Hospital, Slough, SL2 4HL, UK.
authors.forename: C
authors.initials: C
authors.lastname: Aldren
mesh_terms: D001298:Audiology / Q000295:instrumentation; D002648:Child; D002675:Child, Preschool; D005260:Female; D006309:Hearing / Q000502:physiology*; D034381:Hearing Loss / Q000628:therapy; D006801:Humans; D008297:Male; D010034:Otitis Media with Effusion / Q000150:complications / Q000628:therapy*; D012449:Safety; D016896:Treatment Outcome; D054928:Validation Studies as Topic