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Update on first African clinical trial on earpopper for the treatment of otitis media with effusion
Titus Sunday Ibekwe1, Enoch Auta Dahilo2, David Folorunso3
1Department of Otorhinolaryngology, University of Abuja Teaching Hospital and University of Abuja; Division of Otorhinolaryngology, Garki Hospital, Abuja, Nigeria.
Insights
The EarPopper device shows promise for treating otitis media with effusion (OME) in African populations. This study found significant improvement in most patients undergoing EarPopper therapy for OME.
Area of Science:
- Otolaryngology
- Medical Devices
- Public Health
Background:
- Otitis media with effusion (OME) is a common middle ear condition, particularly in children, which can lead to developmental issues if untreated.
- OME involves the accumulation of serous fluid in the middle ear and can be managed through surgical, pharmacological, or physiological methods.
- The EarPopper is a medical device designed for the physiological management of OME and Eustachian tube dysfunction.
Purpose of the Study:
- To evaluate the effectiveness and suitability of the EarPopper device for treating OME in an African setting.
- To assess the impact of EarPopper therapy on patient-reported outcomes and audiometric parameters in individuals with OME.
Main Methods:
- A prospective interventional study involving 45 participants diagnosed with OME across four medical centers in Abuja.
- Diagnosis was confirmed using pneumatic otoscopy, video-otoscopy, tympanometry, and pure-tone audiometry.
- Participants underwent serial EarPopper sessions twice weekly for 2-12 weeks, with outcomes assessed via the EarPopper scoring system (ESS) and audiometric measurements.
Main Results:
- Out of 45 enrolled patients, 32 completed the treatment, showing an 81.3% improvement rate.
- A significant reduction in the EarPopper scoring system (ESS) was observed, from a baseline of 2.45%-84% to 1%-9.8% post-treatment.
- 18.9% of patients experienced persistent symptoms, indicating a potential risk for progression to chronic otitis media.
Conclusions:
- The EarPopper device demonstrates a positive prospect for managing OME in African populations.
- The study suggests that EarPopper can be an effective physiological management option for OME.
- Further research may be warranted to explore long-term outcomes and optimize treatment protocols.
Background:
Otitis media with effusion (OME) is a middle ear condition characterized by the accumulation of serous fluid. It is common, though not exclusive; among children with its attendant developmental consequence if missed or untreated in early life. OME could be managed surgically, pharmacologically, or physiologically. EarPopper is a medical device developed for physiologic management of OME, Eustachian tube dysfunction, and related problems. We aim to ascertain the suitability/efficiency of EarPopper® device for the treatment of OME in our setting.
Methodology:
This is a prospective interventional study of volunteers diagnosed with OME from four (4) medical centers in Abuja. Pneumatic otoscopy, video-otoscopy, tympanometry, and pure-tone audiometry were done to confirm the diagnosis. Serial EarPopper sessions were performed twice weekly for 2-12 weeks, and outcome was assessed using patients' reports. The reports include the EarPopper scoring system (ESS) and audiometric parameters (before and after therapy).
Results:
Forty-five patients (17 males and 28 females) aged between 3-56 years were enrolled. Thirty-five were diagnosed with bilateral OME and 10 unilateral. All patients had Type-B tympanometry tracing with mild-to-moderate conductive hearing losses and ESS of between 2.45% and 84%. Out of the 45 participants, 32 (71.1%) completed the treatment, whereas 13 (28.9%) were lost to follow-up. Duration of EarPopper treatment ranged from 2 to 12 weeks. The outcome revealed improvement in 26/32 (81.3%) with significant reduction in ESS (1% to 9.8%). Six patients 6/32 (18.9%) had persistence symptoms. These 18.9% had the propensity to progress to chronic OME.
Conclusion:
This study highly suggests good prospect in using EarPopper for the management of OME among Africans.
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