BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHONAK VIRTO P50-312

    MDR report key: 21858387 · Received April 17, 2025

    Report

    Report Number
    3005085999-2025-00009
    Event Type
    Injury
    Date Received
    April 17, 2025
    Report Date
    March 26, 2025
    Manufacturer
    SONOVA AG
    Product Code
    OSM
    UDI-DI
    07613389452037
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP WITH THE HCP AND PATIENT'S RELATIVE HAS BEEN CARRIED TO CLARIFY THE NATURE OF INCIDENT (ALLERGY / INFECTION). THE INFORMATION OBTAINED CONFIRMS INFECTION. THE PATIENT / HCP REQUESTED A REMAKE OF THE HEARING AIDS AND SENT THEM BACK TO THE MANUFACTURER. THE HIS WERE RECEIVED BY THE MANUFACTURER. APPLICABLE ADJUSTMENTS HAVE BEEN MADE TO THE DEVICES. THE MODELING FILES OF INITIAL AND REMAKE ORDER HAVE BEEN REVIEWED. VIRTO P IS AN ITE HEARING AID AND ITS OUTER SHELL IS INDIVIDUALLY PRODUCED FOR EACH CLIENT TO FIT THE PATIENTS' EAR ANATOMY. THE HEARING AIDS WERE MANUFACTURED BASED ON THE PATIENT'S EARS IMPRESSIONS IN A WAY TO PROVIDE FOR BEST AUDIOLOGICAL GAIN TO COMPENSATE FOR THE HEARING LOSS OF THE PATIENT. THE SEAL THE EAR CANAL NEEDED TO PROVIDE FOR THE CONTROLLED ACOUSTIC COUPLING WAS ADJUSTED TO THE PARAMETERS OF THE PATIENT'S EAR IMPRESSION. A TIGHT SEAL MAY FOSTER RESTRAINED AIR CIRCULATION AND MOISTURE ACCUMULATION, WHICH FOR PATIENTS SUSCEPTIBLE FOR INFECTIONS MAY LEAD TO INFECTION DEVELOPMENT. THIS IS HOWEVER A WELL-KNOWN DISADVANTAGE OF CONVENTIONAL HEARING AIDS, WIDELY DESCRIBED IN AVAILABLE LITERATURE AND PRESENTED IN THE CLINICAL EVALUATION REPORT OF THE SUBJECT DEVICE. THE RISK FILE OF THE DEVICE ALREADY CONSIDERS AND ADDRESSES THE RISK OF EAR INFECTION.. THE USER GUIDE OF THE DEVICE CONTAINS THE DEVICE CARE AND MAINTENANCE INSTRUCTIONS, DEDICATED INFORMATION ON SAFETY (EXPLAINING HOW TO STORE THE DEVICE WHEN NOT USED TO ENABLE EVAPORATION OF MOISTURE) PLUS A WARNING TO INFLAMMATION/SKIN IRRITATION REQUIRING CHECK WITH AN HCP OR PHYSICIAN. ONCE THE DEVICES WERE RETURNED FOR REMAKE, THERE WERE SEVERAL ADJUSTMENTS MADE TO THE HIS FOLLOWING THE REMAKE ORDER PLACED BY THE HCP. THE ADJUSTMENTS CARRIED OUT ENABLE FOR MORE RELAXED FIT OF THE HIS TO THE PATIENT'S EAR CANAL THAT WOULD LOOSEN THE SEAL AND ALLOW FOR MORE AIR CIRCULATION (SHELL REMODELING, VENT CHANGE, ADDITIONAL RELAXING CUTS). THE HIS WERE RETURNED TO THE CLINIC AND WERE FITTED BACK TO THE PATIENT ON (B)(6). THE PATIENT IS DOING WELL WITH THE REMADE HEARING AIDS, WITH NO SIGNS OF INFECTION. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 0

    IT HAS BEEN BROUGHT TO THE MANUFACTURERS ATTENTION THAT THE PATIENT SUFFERED FROM SWELLING AND REDNESS IN THE EAR POTENTIALLY LINKED TO THE USE OF HEARING AIDS. INITIALLY SUSPECTED ALLERGY REACTION WAS DISPROVED BY THE PATIENT'S DAUGHTER. ACCORDING TO THE PATIENT'S DAUGHTER, THE PATIENT HAS VISITED A FAMILY DOCTOR, WHO DIAGNOSED EAR INFECTION AND PRESCRIBED ANTIBIOTICS DROPS (CIPROFLOXACIN) ON (B)(6). PATIENT'S DAUGHTER REPORTS THE INFECTION IS IMPROVING GREATLY WITH ANTIBIOTICS TREATMENT. SHE ALSO UNDERLINES THAT THE PATIENT HAS NO ALLERGIES OR A HISTORY OF ALLERGIES. THE EVENT CONCERNS BOTH EARS AND BOTH DEVICES: 2505W19F & 2505W19G. A SEPARATE REPORT HAS BEEN FILED FOR DEVICE2505W19F: 3005085999-2025-00008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32772 PHONAK VIRTO P50-312 AIR-CONDUCTION HEARING AID, IN-THE-EAR OSM SONOVA AG 063-0510-01 07613389452037

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other