Earflo (EF001)

The Earflo is a rechargeable, hand-held device that treats negative middle ear pressure by delivering controlled pressurized air into the nasal passages, synchronized with swallowing. It is intended for use in children aged two years and older (under adult supervision) and adults to relieve negative middle ear pressure, prevent fluid accumulation, and prevent hearing loss.

Earflo is an over-the-counter, reusable, non-sterile device with an electronic base, microcontroller-driven pump, integrated sippy-cup assembly, interchangeable nasal masks, and optional Bluetooth-enabled mobile app. Key differences include lower maximum pressure for reduced nasal discomfort, transient increased airflow during swallowing for better sealing, and interchangeable interface options to accommodate anatomical variations.

Testing included electrical safety and EMC, air pressure and airflow rate testing, software verification, packaging and transportation, usability, and biocompatibility testing. The document references relevant consensus standards but does not explicitly cite specific ISO, IEC, or ASTM standard numbers.

The subject and predicate devices share the same intended use, indication for use, and similar technological characteristics, materials, principles of operation, and design features. Performance testing demonstrates that Earflo is as safe, effective, and performs as well as the predicate device, with nonclinical data providing reasonable assurance of safety and effectiveness supporting substantial equivalence.