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.
RCT Entities:
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.