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Does the EarPopper(®) device improve hearing outcomes in children with persistent otitis media with effusion? A
Insights
The EarPopper device safely improved hearing in children with persistent otitis media with effusion (OME). This treatment option reduced the need for ventilation tube insertion, offering a non-surgical alternative for pediatric hearing loss.
Area of Science:
- Pediatric Otolaryngology
- Audiology
- Medical Device Evaluation
Background:
- Otitis media with effusion (OME) is a common cause of hearing loss in children.
- Persistent OME often leads to ventilation tube insertion.
- Evaluating non-invasive treatment options for OME is crucial.
Purpose of the Study:
- To assess the efficacy and safety of the EarPopper device in improving hearing in children with OME.
- To determine if the EarPopper reduces the rate of ventilation tube insertion in pediatric patients.
Main Methods:
- Randomized single-blinded controlled trial involving 29 children aged 4-11 years with persistent OME.
- Children were randomized into a treatment group (EarPopper) or a control group for 7 weeks.
- Audiologists were blinded during post-treatment audiogram assessment.
Main Results:
- The EarPopper group showed a significant mean improvement in air conduction of 10.9 dBHL (P < 0.001) compared to 3.6 dBHL in the control group.
- The ventilation tube insertion rate was lower in the treatment group (53.3%) versus the control group (78.6%).
- Over 90% compliance with the EarPopper was reported, with minor, transient discomfort as the only side effect.
Conclusions:
- The EarPopper is a safe and effective treatment for hearing loss associated with persistent OME in children.
- The device demonstrates potential in reducing the need for ventilation tube insertion.
- Larger studies are recommended to further validate these findings.
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.
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