Earflo wins FDA nod for pediatric ear pressure treatment device

Earflo announced that it received FDA clearance for its non-invasive device designed to treat negative middle ear pressure in children.

San Carlos, California-based Earflo developed its device for children as young as two, providing an in-home alternative during the “watchful waiting” period often prescribed before ear tube surgery (tympanostomy), the most common pediatric surgery in the U.S., according to a news release.

The company says current treatment requires a three-month observation period. During this time, symptoms may interfere with learning and daily activities. If the condition fails to resolve, physicians often recommend ear tube surgery. The company says nearly 1 million children in the U.S. undergo this procedure each year.

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