Does the EarPopper® device improve hearing outcomes in children with persistent otitis media with effusion? A randomised single-blinded controlled trial

• Published in: Clinical otolaryngology 2016-02, Vol.41 (1), p.59-65
• Main Authors: Banigo, A., Hunt, A., Rourke, T., Whiteside, O., Aldren, C.
• Format: Article
• Language: English
• Subjects: Audiology - instrumentation; Child; Child, Preschool; Female; Hearing - physiology; Hearing Loss - therapy; Humans; Male; Otitis Media with Effusion - complications; Otitis Media with Effusion - therapy; Safety; Treatment Outcome; Validation Studies as Topic
• ISSN: 1749-4478; 1749-4486
• DOI: 10.1111/coa.12480

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