A Novel Autoinflation Device to Treat Pediatric Otitis Media with Effusion: Prospective Cohort Study

Introduction: Otitis media with effusion (OME) affects around 90% of pre-school children with about 2.2 million diagnosed annually in the U.S. Current guidelines recommend tympanostomy tubes for patients with persistent OME and hearing loss after 3 months of “Watchful Waiting.” Left untreated, OME can result in chronic conductive hearing loss, developmental delays, and reduced quality of life (QOL). A pilot study demonstrated strong potential benefit in regular middle ear ventilation with a novel autoinflation device. This study aimed to evaluate longitudinal audiometric outcomes for patients with OME using this device.

Methods: This prospective cohort study (HRE2020-0526) evaluated an autoinflation device disguised as a drinking bottle, which aligns the child’s nose with a nasal mask that gently pressurizes the nasal cavity in coordination with swallowing, assisting in Eustachian tube opening. Children aged 1-12 years with OME or Eustachian tube dysfunction (ETD) were recruited from a pediatric ENT clinic from May to November 2024 and used the device daily for 4 weeks. Baseline audiometry and tympanometry was performed at recruitment, with additional audiometry testing at weeks 2 and 4. Tympanometry was repeated after first use and at 2, 4, 8, and 12 weeks. OM-6 QOL survey was administered at recruitment and 8 weeks. Results were compared using paired t-test.

Results: 21 patients and 42 ears were included (71% male, mean 5.6 years). Ears with baseline hearing loss (average 25.6 dBHL) demonstrated an average improvement in pure tone average of 10.8 dB at 2 weeks and 8.6 dB at 4 weeks compared to baseline (p < 0.01). Average middle ear pressure improved from -341.5 daPa at baseline to -202.6 daPa (p < 0.01) after 2 weeks of use and remained stable at -209.2 daPa after 4 weeks of use (p < 0.01). Average OM-6 scores at 8 weeks were significantly improved compared to baseline (p < 0.05).

Conclusions: Regular ventilation of the middle ear with a novel autoinflation device for patients with OME or ETD undergoing “Watchful Waiting” demonstrates significant improvement in audiometry and tympanometry outcomes in as early as 2 weeks.