BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGNIA ACTIVE / SIGNIA ACTIVE PRO

    MDR report key: 24954903 · Received April 22, 2026

    Report

    Report Number
    MW5187152
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Report Date
    April 20, 2026
    Manufacturer
    SIGNIA GMBH/SIVANTOS GMBH
    Product Code
    OSM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SIGNIA ACTIVE AND ACTIVE PRO HEARING AIDS DISCONNECT FROM THEIR CHARGING TERMINALS, EVEN AFTER REPORTING A SOLID CONNECTION WITH A GREEN LIGHT, CAUSING THE BATTERIES TO DRAIN, RENDERING THE HEARING AIDS USELESS WHEN A USER GOES TO USE THEM. BECAUSE THEY ARE DESIGNED TO CONNECT AUTOMATICALLY TO OTHER BLUETOOTH DEVICES (COMPUTERS, PHONES), WHEN THEY DISCONNECT THEY HIJACK THOSE DEVICES AS WELL. SIGNIA URGES USERS TO CLEAN THE TERMINALS, BUT THIS IS NOT EFFECTIVE. THE PROBLEM IS THAT THE TERMINALS ARE RECESSED IN THE CHARGING CASE AND THE MAGNETIC CONNECTION IS NOT SUFFICIENT TO OVERCOME THIS DISTANCE. WITH EACH PAIR COSTING UP TO $5000, SIGNIA HAS MADE A WINDFALL FROM HEALTH INSURANCE COMPANIES SELLING THESE DEFECTIVE HEARING AIDS. HECC: 4582. DPC: 1171, 1057, 4065, 4037. REF: MW5187151, MW5187153, MW5187154.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020354 SIGNIA ACTIVE / SIGNIA ACTIVE PRO HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY, PRESCRIPTION OSM SIGNIA GMBH/SIVANTOS GMBH SR-ACTIVE L/R RGD SNW

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male