BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHONAK CHARGERGO RIC

    MDR report key: 24533062 · Received March 6, 2026

    Report

    Report Number
    24533062
    Event Type
    Malfunction
    Date Received
    March 6, 2026
    Date of Event
    December 10, 2025
    Report Date
    December 17, 2025
    Manufacturer
    SONOVA AG
    Product Code
    OSM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    [REDACTED] HAS RECEIVED OVER 4 REPORTS NATIONWIDE IN REGARDS TO PHONAK SPHERE HEARING AIDS GETTING WARM AND OVERHEATING POTENTIALLY COULD LEAD TO BURNS. ALSO SITES CONTACTED THE MANUFACTURER REGARDING THE ISSUE. ANOTHER REPORT MENTIONED PATIENT WAS USING A NON-MANUFACTURER PROVIDED CHARGING CORD AND PLUG WITH HIS HEARING AID CHARGING CASE (PHONAK CHARGERGO RIC I SN [REDACTED]). THE CASE OVERHEATED AND BECAME SWOLLEN/MELTED/DAMAGED. THIS DEVICE WAS REPLACED WITH A NEW ONE FROM CLINIC STOCK AND PATIENT WAS RE-EDUCATED ON USING ONLY THE ITEMS PROVIDED BY THE MANUFACTURER TO WHICH HE ARTICULATED HIS UNDERSTANDING. INFORMATION ON THE DEFECTIVE DEVICE SENT TO OUR MANUFACTURER REPRESENTATIVE AND THE DEVICE WAS SENT TO PHONAK. MANUFACTURER RESPONSE FOR PHONAK/SONOVA MODEL: AUDEO I90 SPHERE-R RIC, (BRAND NOT PROVIDED) (PER SITE REPORTER). RETURNED FOR EVALUATION AND NO RESPONSE YET. MANUFACTURER RESPONSE FOR SONOVA PHONAK, (BRAND NOT PROVIDED) (PER SITE REPORTER). THE PHONAK REGIONAL ACCOUNT MANAGER WAS NOTIFIED, AND THE CHARGER AND CORD WERE RETURNED TO THE MANUFACTURER BY THE REPORTER. MANUFACTURER RESPONSE FOR PHONAK CHARGERGO RIC I SN [REDACTED]), (BRAND NOT PROVIDED) (PER SITE REPORTER). PER PHONAK REPRESENTATIVES, THERE COULD BE AN INCREASED RISK TO THIS OCCURRING WHEN NON-PHONAK CHARGING CORDS/ADAPTERS ARE USED WITH THEIR CHARGERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591602 PHONAK CHARGERGO RIC HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY OSM SONOVA AG PHONAK CHARGERGO RIC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other