BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHONAK LYRIC 4

    MDR report key: 22478920 · Received July 11, 2025

    Report

    Report Number
    3005085999-2025-00016
    Event Type
    Injury
    Date Received
    July 11, 2025
    Report Date
    July 2, 2025
    Manufacturer
    SONOVA AG
    Product Code
    ESD
    UDI-DI
    07613389250893
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER HAS CONDUCTED A FOLLOW UP WITH THE HCP TO GATHER MORE INFORMATION ON THE INCIDENT. IT'S BEEN REPORTED THAT THE DEBRIS WAS CONSISTENT WITH OTITIS EXTERNA. THE PATIENT SAW ENT NURSE PRACTITIONER AND DEBRIS WAS SUCTIONED, HE WAS PRESCRIBED EAR DROPS FOR 1 WEEK, RETURNED TO THE CLINIC AFTER COMPLETION OF THOSE AND HAD GENTIAN VIOLET APPLIED TO THE CANAL. THE HCP INDICATED THAT PATIENT OPTED TO CONTINUE WITH LYRIC AFTER OBTAINING MEDICAL CLEARANCE FOR NOW, AS IT IS HIS PREFERRED DEVICE. NEW LYRIC DEVICE INSERTED. THE PATIENT IS COMING TO THE CLINIC LATER THIS MONTH TO DISCUSS DAILY WEAR ALTERNATIVE GIVEN THAT THIS IS THE SECOND OCCURRENCE OF OTITIS EXTERNA. HE HAS HAD ONE OTHER EPISODE SINCE STARTING LYRIC AROUND 15 MONTHS AGO. PATIENT DID NOT REPORT PAIN OR NOTE DRAINAGE UNTIL CLINICIAN OBSERVED IT. THE HCP FELT THAT IT WAS LIKELY THAT THE CONDITION WAS DUE TO LYRIC USE. MEDICAL PROVIDER HAS ADVISED TO DISCONTINUE LYRIC ONCE DAILY WEAR SELECTION IS MADE. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS. THE RISK OF ACCUMULATION OF MOISTURE IN THE EAR DUE TO DEVICE'S DESIGN AND SEALED FIT IN THE EAR HAS BEEN ALREADY CONSIDERED IN THE ACCOMPANYING RISK FILE. THE IFU ACCOMPANYING THE DEVICE LISTS ACTIONS TO TAKE WHEN EAR PAIN, IRRITATION OR INFLAMMATION OCCURS AND SEEKING MEDICAL ADVICE REFERRAL CRITERIA. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 0

    IT HAS BEEN BROUGHT TO MANUFACTURER'S ATTENTION THAT THE PATIENT HAS NOTICED EXCESS FLUID COLLECTION AND WHITE, THICK DEBRIS IN THE EAR UPON REMOVAL OF THE DEVICE AND SOUGHT MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677518 PHONAK LYRIC 4 AIR-CONDUCTION HEARING AID, CANAL ESD SONOVA AG 078-0063 07613389250893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other