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Feasibility of a Novel Autoinflation Device to Treat Pediatric Otitis Media With Effusion At-Home
Maria-Jose Soto1, Nanki Hura2, Intan Oldakowska1
1Centre for Medical Research at the University of Western Australia Crawley Western Australia Australia.
Insights
A novel autoinflation device shows promise for treating children with otitis media with effusion (OME). At-home use improved middle ear pressure and hearing loss in most patients within 4 weeks.
Area of Science:
- Pediatric Otolaryngology
- Biomedical Engineering
- Audiology
Background:
- Otitis media with effusion (OME) is highly prevalent in children, often leading to conductive hearing loss.
- Current guidelines recommend tympanostomy tubes for persistent OME, but non-surgical options are limited.
- Prolonged OME can risk long-term hearing impairment, necessitating effective interventions.
Purpose of the Study:
- To evaluate the feasibility and efficacy of a novel prototype autoinflation device for home use in children with OME or eustachian tube dysfunction.
- To assess the impact of the device on middle ear pressure and hearing outcomes.
- To determine patient compliance with at-home autoinflation therapy.
Main Methods:
- A single-arm cohort study involving 21 children aged 1-12 years with OME.
- Participants used the autoinflation device twice daily for 4 weeks.
- Audiometry and tympanometry were performed at baseline, with follow-up tympanometry and 4-week audiometry; compliance was tracked via an app.
Main Results:
- 86% of patients showed improved middle ear pressure after one session, maintained by 83% at 4 weeks.
- 86% of patients with baseline hearing loss demonstrated improvement at 4 weeks.
- Average pure tone average improved from 26.8 to 18.9 dB HL in affected ears.
Conclusions:
- The autoinflation device demonstrated significant improvements in tympanometry and audiometry outcomes.
- Regular middle ear ventilation using this device shows strong potential benefits for pediatric OME patients.
- Home-based autoinflation offers a promising non-surgical approach for managing OME during watchful waiting periods.
Objective:
Otitis media with effusion (OME) affects 90% of children before school age, with current guidelines recommending tympanostomy tubes for persistent OME and hearing loss after 3 months of "Watchful Waiting," due to the risk of complications including long-term conductive hearing loss. Current nonsurgical treatment options are limited. This study evaluates the feasibility of at-home use of a novel prototype autoinflation device for children with OME or eustachian tube dysfunction.
Study Design:
Single-arm cohort study.
Setting:
Pediatric otolaryngology private clinic.
Methods:
Children aged 1 to 12 years with OME were recruited from a pediatric otolaryngology clinic and asked to use the device twice daily for 4 weeks. Baseline audiometry and tympanometry were performed at recruitment, with subsequent tympanometry testing after first use and at 2, 4, 8, and 12 weeks. Audiometry testing was repeated at week 4. Compliance was tracked using an App.
Results:
Twenty-one patients were included (average age: 5.1 years, range: 2-12 years). After a single session, 86% of patients had middle ear pressure improvement in at least one ear, which maintained stable at 83% at week 4. Additionally, 86% of patients with hearing loss exhibited improvement at 4 weeks, where the average pure tone average in ears with baseline hearing loss improved from 26.8 to 18.9 dB HL.
Conclusion:
These results demonstrate significant improvement in both tympanometry and audiometry after 4 weeks of device use. This indicates a strong potential benefit in regular ventilation of the middle ear for pediatric patients with OME undergoing "Watchful Waiting."
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