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

Sunday, October 12, 2025

8:06 AM - 8:12 AM EDT

Location: 244

Disclosure(s):

Nanki Hura, MD:

faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.

Peter L. Santa Maria, MD, PhD:

faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.

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.

Presenting Author(s)

NH

Nanki Hura, MD

Resident Physician
University of Pittsburgh Medical Center - Medical Education Program
Pittsburgh, Pennsylvania, United States

Disclosure(s):
faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.

Co-Author(s)

Maria-Jose Soto, MPE

Biomedical Engineer and Research Officer
Centre for Medical Research at the University of Western Australia
Myaree, Western Australia, Australia

Disclosure information not submitted.
PB

Paul E. Bumbak, BSc (Hons), MBBS, FRACS

Head of Department of ENT Surgery
Perth Children’s Hospital
Nedlands, Western Australia, Australia

Disclosure information not submitted.
Intan CW Oldakowska, PhD

Senior Lecturer
University of Western Australia
APPLECROSS, Western Australia, Australia

Disclosure information not submitted.
MO

Matt P. Oldakowski, PhD, BEng(Hons)

Chief Technical Officer
EarFlo Inc
Perth, Western Australia, Australia

Disclosure information not submitted.

Senior Author(s)

PS

Peter L. Santa Maria, MD, PhD

Professor
University of Pittsburgh Department of Otolaryngology
Palo Alto, PA, United States

Disclosure(s):
faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.