Feasibility of a Novel Autoinflation Device to Treat Pediatric Otitis Media With Effusion At-Home.

Abstract

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."