BEUDAMED
    FDA Adverse Event Other Summary report: N

    EARGO 7 OTC HEARING AID

    MDR report key: 16877064 · Received May 4, 2023

    Report

    Report Number
    MW5117278
    Event Type
    Other
    Date Received
    May 4, 2023
    Date of Event
    April 19, 2023
    Report Date
    April 19, 2023
    Manufacturer
    EARGO INC.
    Product Code
    QUH
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS SOLD AN OTC HEARING AID BY EARGO AND THE PATIENT HAS UNILATERAL HEARING LOSS. THE PATIENT WAS NOT TOLD TO SEE AN AUDIOLOGIST BY EARGO DUE TO THE UNILATERAL HEARING LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2212720 EARGO 7 OTC HEARING AID SELF-FITTING AIR-CONDUCTION HEARING AID, OVER THE COUNTER QUH EARGO INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Other