BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WIDEX

    MDR report key: 23742588 · Received December 8, 2025

    Report

    Report Number
    0002430101-2025-00009
    Event Type
    Injury
    Date Received
    December 8, 2025
    Date of Event
    June 26, 2025
    Report Date
    May 13, 2026
    Manufacturer
    WS AUDIOLOGY USA, INC.
    Product Code
    OSM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INPUT FROM RISK MANAGEMENT: AFTER MITIGATION: SEVERITY 2 (MODERATE) AND PROBABILITY B (IMPROBABLE) HAS RESIDUAL RISK RANGE CATEGORY II (ACCEPTABLE, RISK LEVEL MITIGATED AS LOW AS POSSIBLE). THERE IS A CAPA OPENED TO ADDRESS THIS EVENT.

    Description of Event or Problem · 0

    IN THIS EVENT, PATIENT WAS FITTED WITH ALLURE RIC (RECEIVER IN CANAL) HEARING AIDS WITH CUSTOM HARD SOLID SHELLS ON (B)(6) 2025. THE PATIENT IS AN EXPERIENCED CUSTOM CIC (COMPLETELY IN CANAL) HEARING AID USER AND HAS NO KNOWN ALLERGIES. THIS WAS THE PATIENT'S FIRST EXPERIENCE WEARING RIC DEVICES WITH CUSTOM SHELLS. APPROXIMATELY ONE MONTH AFTER FITTING, THE PATIENT REPORTED PERSISTENT EAR CANAL ISSUES, INCLUDING ITCHING, REDNESS AND OOZING. THE PATIENT WAS EVALUATED AND TREATED BY AN ENT DOCTOR ON MULTIPLE OCCASIONS ((B)(6) 2025) WITH ORAL ANTIBIOTICS, STEROIDS, DROPS, AND CREAMS. AFTER EACH VISIT, THE PATIENT WAS INSTRUCTED TO DISCONTINUE HEARING AID USE FOR TWO WEEKS. SYMPTOMS RESOLVED DURING THESE PERIODS BUT RECURRED UPON RESUMING USE OF THE HEARING AIDS. COURTESY REPLACEMENT SHELLS (HARD AND SOFT) WERE PROVIDED. THE PATIENT TRIALED A SOFT MOLD IN THE RIGHT EAR FOR ONE WEEK WHILE LEAVING THE LEFT EAR WITHOUT AN AID; SYMPTOMS DEVELOPED IN THE RIGHT EAR ONLY. SUBSEQUENTLY, THE PATIENT TRIALED A HARD MOLD IN THE LEFT EAR WHILE LEAVING THE RIGHT EAR WITHOUT AN AID; SYMPTOMS DEVELOPED IN THE LEFT EAR ONLY. THE PATIENT CONTINUES TO BE MONITORED BY AN ENT DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623086 WIDEX EAR MOLDS OSM WS AUDIOLOGY USA, INC. FLEX HARDSOLIDPRW V2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention