이어플로(Earflo)

Common in infants and young children,otitis media with effusion (chronic recurrent middle ear effusion)causes hearing loss and pain, but it is not easily cured with medication, and the ultimate treatment was surgery to insert a ventilation tube (commonly known as an ear tube) into the eardrum. However, this surgery requires general anesthesia, and the tube may fall out and cause recurrence, which is a burden for both parents and children. In addition, during the waiting period for surgery, children are continuously exposed to the risk of language development delays or eardrum damage.

Self-treatment that can be done at home includes equalization (Valsalva maneuver), which involves holding the nose and blowing air, but young children have difficulty cooperating. As a result,"There is no way to non-surgically relieve the negative pressure in a child's middle ear."This was a concern for parents and pediatricians.

Against this background, there was a need for a solution that could easily drain fluid from the middle ear at home without anesthesia or incision to alleviate chronic otitis media.

Earflo takes a completely different non-invasive approach from existing treatments, implementinga 'playful treatment' that children aged 2 and older can use without resistance.Specifically, the product is designed in the form of a sippy cup that children like, so when the child sucks a drink from the cup, the sensor detects the swallowing motion and simultaneously automatically injects a soft air pulse into the nose. This precisely controlled air pressure opens the blocked Eustachian tube, relieving the negative pressure in the middle ear and draining the fluid (effusion) accumulated inside the eardrum.

Treatment is done by simply having the child drink from the cup for a few minutes a day, and because it is done without pain or discomfort, the child does not cry or get scared. In addition, the real-time weight sensor allows you to monitor how much fluid has been drained, and the linked app providesgamificationprogress display and data tracking for parents and doctors.

In summary, Earflo is an innovative principle that"treats the ear simply by the child drinking a beverage,"making it a safe and convenient solution that completely replaces surgery or medication. World's thinnest 15cm logistics robot, CARRIE - HL Robotics

Parents of children suffering from otitis media will be the direct purchasers of this product. Otitis media is very common in infants and young children worldwide, and it is expected to attract great interest from parents who visit ENT (ear, nose, and throat) clinics for pediatric hearing problems. Primarily, it can be a B2C medical device model in which parents purchase/rent the device after a hospital prescription.

At the same time,pediatric hospitals or ENT clinics (B2B)can introduce it as a treatment aid and use it as a pre-surgery step for patients with mild otitis media. For example, a doctor can guide the use of Earflo, and parents can administer it to their children at home. In addition,public health centers or school nurse's offices (B2G)can consider providing it to children with multiple cases of otitis media.

However, currently, it is being positioned as a home-use medical device that parents can use at home after regulatory approvals such as the FDA, sothe ultimate purchaser is likely to be parents (individuals).가 될 가능성이 높다.

The demand for otitis media treatment exists everywhere in the world, so the market is very large if regulatory approval is obtained. In the United States, Europe, etc., there are already permanent chemical substances (PFAS) – Oh, it's not PFAS here, it's otitis media. I stand corrected. – Globally, more than 80% of children have otitis media at least once before the age of 3, so it is universal.

Earflo is currently awaiting FDA 510(k) approval, and its safety and efficacy have been proven in clinical studies, so global expansion is likely after approval. In terms of regulation, it is classified as a medical device Class II, so it must be certified in each country, but it is expected to be relatively easy because it is not invasive.

In addition, this technology can be applied to other markets such as relieving ear barotrauma that occurs during airplane take-off and landing in adults, or ear pressure regulation training for divers/pilots. However, realistically, the largest market is for infants and young children, and there is room for expansion by diversifying the product lineup into mask forms in addition to cup forms to expand the applicable age range.

Overall, Earflo is a solution with the potential to impact the global pediatric market without specific national or environmental constraints.

It was recognized for its innovation by being selected as the winner of the Best of Innovation Award in the digital health field. With expectations that it is a *"game changer that can replace ear tube surgery,"* the technology demonstrated on-site received positive feedback that it"looks safe and painless."In particular, the judging panel reportedly gave high scores, saying that it *"presented a new path for the treatment of pediatric otitis media, which had been dependent on surgery."

IT media such as ZDNet cited Earflo as one of the most useful technologies for parents at CES, and IEEE Spectrum also showed interest, calling it *"an otitis media treatment device that does not make children cry."* In terms of technological completeness, clinical studies published in 2025 have proven its safety and significant effectiveness, so expectations from the medical community are also high.

However, since it has not yet been sold, it remains to be seen "whether children will cooperate sufficiently in actual use" and "how much parents will accept it." Overall, it is being unanimously praised as *"an innovation in pediatric otitis media treatment that has not changed for decades"* without being underestimated.