An award-winning Australian-developed ‘sippy cup’ which offers a non-surgical solution for children with negative middle ear pressure and fluid buildup has received Food and Drug Administration (FDA) Clearance.
Biomedical engineers and ENT specialists within Earflo medical technology company pioneered the non-invasive at-home paediatric ear care device which is designed to treat children as young as two.
It announced the US market availability and FDA Clearance of the device in a media release on 29 April 2026. The device combines precision pressure therapy with a child-friendly design and companion app to support consistent treatment.
The company said Earflo provided families with an at-home alternative during the “watchful waiting” period often prescribed before surgery for children with chronic ear infections.
This addressed a condition that affected millions of children worldwide and frequently led to grommet insertion, a common paediatric surgery in the US and Australia.
“Earflo works by delivering a precisely controlled puff of air through the nose into the eustachian tube during swallowing,” the company said. “This helps to equalise pressure in the middle ear and reduce fluid buildup associated with otitis media with effusion (OME).”
Designed as a child-friendly cup and paired with a smart app, the system guides therapy sessions and keeps children motivated through gamified progress tracking.
The app also gives parents and clinicians an easy way to track usage over time.
Will apply for TGA approval
CEO and co-founder of the company, Perth biomedical engineer, Dr Intan Oldakowska said: “We built Earflo because we know how exhausting and heartbreaking it is to watch a little one struggle with ear pain, hearing issues, and disrupted learning.
“Our goal is to give families a simple, science-backed tool they can use at home to address middle ear pressure before it progresses to surgery.”
Dr Oldakowska told Hearing Practitioner Australia: “The Earflo device is now available for purchase in the US only through our website. It is not yet available in any other countries for now.
“We are working towards getting Therapeutic Goods Administration approval as a medical device for use in Australia.”
Impair hearing and speech
Dr Oldakowska said otitis media with effusion affected about 90% of children by age five, and persistent cases could impair hearing and speech development if untreated.
“Current treatment typically involves a three-month observation period, during which symptoms may interfere with learning and daily activities,” she said. “If the condition does not resolve, physicians often recommend ear tube surgery (grommets).”
Something parents can do
University of Pittsburgh chief medical officer, and professor and division chief of otology & neurotology Dr Peter Santa Maria is Earflo’s chief medical officer.
“As an ear surgeon, I’ve spent years watching families face a difficult choice between watchful waiting and putting their toddler under general anaesthesia,” he said.
“Earflo changes that equation. For the first time, parents have something they can actually do, and the clinical data shows it works.”
Peer-reviewed clinical research in Oto Open supported these findings. After a single session, 86% of patients had middle ear pressure improvement in at least one ear, which remained stable at 83% at week four. Additionally, 86% of patients with hearing loss exhibited improvement in hearing at four weeks, where the average pure tone average in ears with baseline hearing loss improved from 26.8 to 18.9 dB HL, and 89% avoided surgery.
Earflo has been recognised in several awards including TIME Best Inventions of 2025, CES Innovation Awards Best of Innovation in Digital Health, and the Gold Anthem Award for Health Innovation.
The awards recognised the device’s design and engineering excellence which transformed therapy into “an intuitive, child-friendly experience while maintaining medical-grade performance”.
Earflo received investment from the Richard King Mellon Foundation, Eye and Ear Foundation of Pittsburgh, and Australian Medical Angels, supporting the company’s path toward FDA clearance, manufacturing scale-up, and bringing the device to families.
Read more
TIME magazine names Australian Earflo for otitis media one of 2025’s best inventions
Otitis media: Breaking down the barriers
ENT public patients waiting longest for elective surgery says AIHW
