BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHONAK HEARING AIDS

    MDR report key: 22187478 · Received June 11, 2025

    Report

    Report Number
    MW5171327
    Event Type
    Injury
    Date Received
    June 11, 2025
    Date of Event
    January 1, 2025
    Report Date
    June 1, 2025
    Manufacturer
    SONOVA USA INC.
    Product Code
    OSM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CREATED TINNITUS NOT RESOLVED BY THE VA. HEARING AIDS DO NOT HELP. ONE SPECIALIST CLAIMS SOMEONE IS THINKING BAD ABOUT HER IN RELIGION AND THAT IS WHAT CAN CREATE THE TINNITUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569648 PHONAK HEARING AIDS HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY, PRESCRIPTION OSM SONOVA USA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Hospitalization