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Late-Breaking Scientific Oral Presentations

Otology/Neurotology

Session: Late-Breaking Scientific Orals: Otology and Neurotology

A Novel Auto-Inflation Device to Treat Pediatric Otitis Media With Effusion: Preliminary Clinical Results

Sunday, September 29, 2024
2:36 PM – 2:42 PM EDT
Location: MBCC, 222
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.

Intan CW Oldakowska, PhD:

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

Matt P. Oldakowski, BEng(hons), PhD:

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

Maria-Jose Soto, MPE, Bsc:

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

Introduction: Otitis media with effusion (OME) affects millions of children each year, with current guidelines recommending tympanostomy tubes for patients with persistent OME and hearing loss after 3 months of “watchful waiting.” However, OME can recur, resulting in repeated surgery with potential for complications. Here we examined the effect of ventilating the eustachian tube for patients with OME or eustachian tube dysfunction (ETD) using a novel auto-inflation device.

Methods: This take-home pilot study (HRE2020-0526) evaluated a prototype auto-inflation device disguised as a drinking bottle, which upon use, aligns the child’s nose with a nasal mask that gently pressurizes the nasal cavity in coordination with swallowing, which assists in eustachian tube opening. Children aged 1-12 years with OME or ETD were recruited from The University of Western Australia in 2024 and used the device daily for 4 weeks. Baseline audiometry and tympanometry was performed at recruitment, with subsequent tympanometry testing after first use and at 2, 4, 8, and 12 weeks. At week 4, audiometry testing was repeated. Results were compared to baseline using a paired t-test.

Results: To date, 17 patients completed the 4-week follow-up (47% female, aged 2-12 years). After a single session, 94% of patients had an immediate tympanogram improvement in at least one ear (p < 0.01). After 4 weeks of use, 82% had tympanogram improvement in at least one ear (p < 0.01). At week 4, 71% of those who were initially diagnosed as having hearing loss had improved hearing thresholds by at least 5dB in at least one ear (p < 0.01, n = 14). 80% of those who improved did so into the normal hearing threshold range in at least one ear (n = 10). Full results are pending trial completion.

Conclusions: These preliminary results demonstrate significant improvement in both tympanometry and audiology after 4 weeks of device use. This indicates a strong potential benefit in ventilating the middle ear during swallowing for patients undergoing “watchful waiting.”

    Presenting Author(s)

  • NH

    Nanki Hura, MD

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

    Disclosure(s):

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

    • Co-Chair(s)

  • Peter L. Santa Maria, MD, PhD

    Professor
    University of Pittsburgh Medical Center
    Palo Alto, CA, United States

    Disclosure(s):

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

    • Co-Author(s)

  • IO

    Intan CW Oldakowska, PhD

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

    Disclosure(s):

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

  • MO

    Matt P. Oldakowski, PhD, BEng(Hons)

    Chief Technical Officer
    EarFlo Inc
    Perth, Western Australia, Australia

    Disclosure(s):

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

  • Maria-Jose Soto, MPE, BSc

    Biomedical Engineer
    UWA Medical School at The University of Western Australia
    Myaree, Western Australia, Australia

    Disclosure(s):

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

    • Senior Author(s)

  • Paul E. Bumbak, MBBS, BSc (Hons)

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

    Disclosure information not submitted.