A novel autoinflation device for persistent pediatric otitis media with effusion: A prospective single-arm cohort study.

BACKGROUND

Autoinflation is a non-surgical option for pediatric otitis media with effusion (OME), but existing devices are limited to children ≥4 years and lack objective adherence confirmation. EarFlo® is a novel prototype autoinflation device designed for younger children with built-in objective treatment detection.

DESIGN

Prospective single-arm cohort study.

SETTING

Single pediatric otolaryngology practice, Western Australia.

PARTICIPANTS

Children aged 1-12 years with persistent OME after ≥3 months of watchful waiting, assessed for tympanostomy tube placement.

INTERVENTION: Four weeks of twice-daily home use of EarFlo® (10 successful treatments per session), followed by 8 weeks of observation without device use.

PRIMARY OUTCOMES: Within-patient serial tympanometric and audiometric changes over 12 weeks.

RESULTS

18 participants completed the study (median age 6 years, range 2-11; 22% < 4 years). Objectively measured adherence was 99% (median). Mean pure tone average (PTA) in ears with baseline hearing loss improved by 12.9 dB HL (95% CI: 7.8 to 17.9) at 2 weeks and 9.7 dB HL (95% CI: 3.7 to 15.7) at 4 weeks in adjusted analyses. Tympanometric improvement was observed in 91% of ears during active device use; 35% (95% CI: [19.7% to 53.5%]) exhibited sustained improvement at final follow-up. 89% of participants (16/18) were not recommended for tympanostomy tube surgery during the observed follow-up period. No adverse events were recorded.

CONCLUSIONS

In children with persistent OME meeting criteria for surgical intervention, EarFlo® demonstrated high objective adherence, no adverse events, and clinically meaningful within-patient tympanometric and audiometric improvements. These findings support further evaluation in randomized controlled trials. This trial is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR12621000949886; registered 15 April 2024, prior to first enrollment in May 2024).