BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    Nuance Audio Hearing Aid Software

    K Number: K243150 · Decision Jan 31, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    123

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Nuance Audio Hearing Aid Software
    K Number
    K243150
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3335
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Luxottica Group S.P.A.
    Date Received
    September 30, 2024
    Decision Date
    January 31, 2025
    Product Code
    SCR
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SCR Air-Conduction Hearing Aid Software

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (SCR), ordered by most recent decision date.

    Tuned Self-Fitting Mobile App

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Hearing Aid Feature (HAF)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat
    View all