Earflo Announces FDA Clearance and US Market Availability of Award-Winning Pediatric Ear Pressure Treatment

Award-winning device recognized by TIME and CES offers a non-surgical solution for children suffering from negative middle ear pressure and fluid buildup, a condition affecting millions of families.

SAN CARLOS, Calif. April 29, 2026 — Earflo, a medical technology company pioneering non-invasive pediatric ear care, today announced the U.S. market availability of its FDA-cleared device designed to treat negative middle ear pressure in children as young as two. The Earflo device provides families with an at-home alternative during the “watchful waiting” period often prescribed before surgery, addressing a condition that affects millions of children and frequently leads to ear tube surgery — the most common pediatric surgery in the United States. Earflo works by delivering a precisely-controlled puff of air through the nose into the eustachian tube during swallowing, helping equalize 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 kids motivated through gamified progress tracking. The app also gives parents and clinicians an easy way to track usage over time. “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,” said Dr. Intan Oldakowska, CEO and co-founder of Earflo. “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.”

Addressing One of Childhood’s Most Common Conditions

Otitis media with effusion affects about 90% of children by age five, and persistent cases can 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. If the condition does not resolve, physicians often recommend ear tube surgery. Nearly one million children in the United States undergo the procedure each year. "As an ear surgeon, I’ve spent years watching families face a difficult choice between watchful waiting and putting their toddler under general anesthesia. Earflo changes that equation. For the first time, parents have something they can actually do, and the clinical data shows it works,” said Dr. Peter Santa Maria, Chief Medical Officer of Earflo and Professor and Division Chief, Otology & Neurotology at University of Pittsburgh. Peer-reviewed clinical research supports these findings: 86% of children had immediate improvement in middle ear pressure. After four weeks, 86% had significantly improved hearing and 89% avoided surgery.

Earflo Recognized for Breakthrough Innovation

Earflo’s approach to pediatric ear care has earned widespread recognition across the technology and healthcare communities. The company has received several major honors, including:
  • TIME Best Inventions of 2025
  • CES Innovation Awards® Best of Innovation in Digital Health
  • Gold Anthem Award for Health Innovation
The awards recognized the device’s design and engineering excellence, which transforms therapy into an intuitive, child-friendly experience while maintaining medical-grade performance.

Backed by Mission-Driven Investments

Earflo has received mission-aligned 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. With FDA clearance and commercial availability now in place, Earflo plans to expand distribution through pediatric healthcare providers and consumer channels, making the technology accessible to families seeking alternatives to surgery for children suffering from otitis media with effusion caused by negative middle ear pressure. “Our mission is to make pediatric ear care simpler, safer, and more accessible,” said Dr. Oldakowska. “With this milestone, we’re giving families a way to address ear pressure early at home so fewer children progress to surgery.”

About Earflo

Earflo is a pioneer in non-invasive, at-home treatment for negative middle ear pressure in young children, a condition that can lead to fluid buildup and chronic ear infections. The device combines precision pressure therapy with a child-friendly design and companion app to support consistent treatment. Earflo was developed by biomedical engineers and ENT specialists and has been recognized by TIME, CES, and the Anthem Awards for innovation in healthcare. Learn more at earflocare.com.