Earflo delivers a precisely controlled puff of air through the nose into the eustachian tube during swallowing to help equalise pressure in the middle ear and reduce fluid buildup associated with otitis media with effusion. Image: Earflo....
No actionable change to audiology practice yet; FDA clearance marks a regulatory milestone but clinical adoption depends on availability, pricing, and comparative effectiveness data against existing treatments.
A non-surgical, non-pharmacological device option for otitis media with effusion could expand the toolkit available to audiologists and ENTs managing middle ear conditions, particularly in paediatric populations.
- 01Earflo has received FDA clearance for treating otitis media with effusion (fluid in the middle ear).
- 02The device delivers a controlled air puff through the nose to equalise middle ear pressure.
- 03It was developed in Australia, marking an international regulatory milestone for the product.
- 04FDA clearance does not equal FDA approval; comparative clinical trial data were not detailed in this release.
- 05Potential alternative to watchful waiting, medications, or surgical grommet insertion.
Earflo uses a controlled puff of air through the nose to equalise middle ear pressure in otitis media with effusion.
press releaseunclearEarflo has received FDA clearance for otitis media with effusion.
press releasesupported
