Non-surgical option for negative middle ear pressure
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. Nasal pressurization is precisely controlled with a pressure sensor and successful treatment indicated with LED lights.1
Contact UsThe Earflo device is FDA 510(k) pending and currently not for sale.
Clinical Studies
The Earflo prototype device has been evaluated in a clinical study and presented at the AAO-HNS and AAP Annual Conference 2024. The study which has been published at OTO Open Journal, demonstrated that 86% of children under watchful waiting had an instantaneous clinical improvement after using the device for a single session, and 86% of patients improved hearing after four weeks of daily use.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, and potentially longer term periodically to prevent recurrence.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 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.
- Soto MJ, Hura N, Oldakowska I, Oldakowski M, Bumbak P, Santa Maria PL. Feasibility of a Novel Autoinflation Device to Treat Pediatric Otitis Media With Effusion At-Home. OTO Open. 2025;9(2):e70128. Published 2025 May 14. doi:10.1002/oto2.70128. https://pubmed.ncbi.nlm.nih.gov/40370996