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510(k) Data Aggregation

    K Number
    K252751

    Validate with FDA (Live)

    Device Name
    Earflo (EF001)
    Manufacturer
    Date Cleared
    2026-02-10

    (165 days)

    Product Code
    Regulation Number
    N/A
    Age Range
    2 - 120
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Earflo is indicated for the treatment of negative middle ear pressure. Negative middle ear pressure can lead to fluid accumulation in the middle ear, impaired hearing, and hearing loss. The Earflo provides a method of ventilating the middle ear by momentarily increasing the air pressure in the nose and the eustachian tube. Equalizing the pressure can prevent the accumulation of fluid and prevent hearing loss.

    Device Description

    Earflo is a rechargeable, hand-held therapeutic device designed to provide treatment of negative middle ear pressure through a non-invasive method. Earflo functions by delivering controlled pressurized air into the nasal passages to ventilate the middle ear by momentarily increasing the air pressure in the nose and eustachian tubes. During use, the child drinks from the integrated sippy cup while the nose is sealed against the device's mask. When liquid is swallowed, a puff of air is delivered into the nasal passage and eustachian tube, thereby opening the eustachian tube and equalizing pressure in the middle ear.

    AI/ML Overview

    N/A

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