Clinical information on the Earflo autoinflation device
Earflo is a next-generation autoinflation device cleverly disguised as a child's sippy cup. Designed to be used by children as young as two, Earflo can treat negative middle ear pressure during normal drinking with no complex coordination required, making it usable in children who cannot yet self-perform the Valsalva maneuver. Nasal pressurization is precisely controlled with a pressure sensor and successful treatment indicated with LED lights.1
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Clinical Studies
In a prospective single-arm cohort study published in the American Journal of Otolaryngology-Head and Neck Medicine and Surgery (2026), 18 children (ages 2-11) with persistent otitis media with effusion after at least 3 months of watchful waiting, and already being evaluated for tympanostomy tube surgery, used Earflo twice daily at home for four weeks. Device adherence, measured objectively by the device's built-in sensor, was 99% (median). Tympanometric improvement was observed in 91% of ears during treatment, and mean hearing thresholds (pure tone average) improved by 12.9 dB HL at 2 weeks and 9.7 dB HL at 4 weeks. By the end of the 12-week follow-up, 89% of participants were not recommended for tube surgery. No adverse events were reported.2
An earlier single-arm feasibility study (n=21, ages 2-12), published in OTO Open and presented at the AAO-HNS and AAP Annual Conferences in 2024, showed that 86% of children under watchful waiting had immediate tympanometric improvement after a single session, 86% had significant hearing improvement after four weeks of daily use, and 89% did not proceed to ear tube surgery at four weeks.1
Treatment Recommendation
The Earflo device can be used as soon as negative middle ear pressure is diagnosed and during the watchful waiting period. Treatment can be done at home daily to potentially resolve middle ear fluid and prevent hearing loss. Some children see an immediate effect after the first treatment, whereas others require treatment of 2-4 weeks.1
Peer-Reviewed Conference Presentations
The team behind Earflo presented the results of clinical studies at multiple conferences, demonstrating the effectiveness of the device to peers in pediatrics and otolaryngology specialties.
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American Academy of Otolaryngology-Head and Neck Surgery 2025 Conference
- Title: A Novel Autoinflation Device to Treat Pediatric Otitis Media with Effusion: Prospective Cohort Study
- Session: Otology/Neurotology Scientific Oral Presentation
- About: The scientific oral presentation session focused on current evidence-based research, surgical procedures, and approaches in the clinical sciences and their application to patient care in the Otology and Neurotology area.
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American Academy of Pediatrics 2024 Conference
- Title: A Novel Auto-Inflation Device to Treat Pediatric Otitis Media With Effusion: Preliminary Clinical Results
- Session: Section on Advances in Therapeutics and Technology
- About: This poster hall session features accepted presentations that showcase Advances in Therapeutics and Technology.
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American Academy of Otolaryngology - Head and Neck Surgery 2024 Conference
- Title: A Novel Auto-Inflation Device to Treat Pediatric Otitis Media With Effusion: Preliminary Clinical Results
- Session: Late-Breaking Scientific Orals: Otology and Neurotology
- About: The AAO-HNSF Annual Meeting Program Committee accepts several Late-Breaking Scientific Oral abstract submissions that are presented during the 2024 Annual Meeting in Miami, Florida.
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36th World Congress of Audiology (2024)
- Title: Earflo
- Session: Innovation in Audiology
- About: The 36th World Congress of Audiology (WCA 2024) brought together leading audiologists, researchers, and industry experts from around the globe to exchange knowledge and advance the field of hearing healthcare. Held in Paris, this prestigious event provided a unique platform for sharing the latest scientific developments, clinical practices, and innovative technologies in audiology.
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American Academy of Otolaryngology - Head and Neck Surgery 2023 Conference
- Title: EarFlo: Treating pediatric OME patients at home during watchful waiting
- Session: ENTpreneur Faceoff
- About: The ENTpreneur Faceoff, supported by the AAO-HNS Medical Devices and Drugs Committee, provides industry entrepreneurs an opportunity to present their early, not yet widely commercially available, innovations in the field of otolaryngology. Earflo presented to a panel of judges and received the runner-up prize.
