BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    Hearing Aid Feature (HAF)

    K Number: DEN230081 · Decision Sep 12, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    2
    Applicant Total
    12
    Review Days
    283

    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
    Hearing Aid Feature (HAF)
    K Number
    DEN230081
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    874.3335
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Unknown
    Applicant
    Apple, Inc.
    Date Received
    December 4, 2023
    Decision Date
    September 12, 2024
    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

    Nuance Audio Hearing Aid Software

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

    Other Clearances by Apple, Inc.

    K Number Device Name
    K253582 Medical Imaging Calibration Feature (MICF)
    K250507 Hypertension Notification Feature (HTNF)
    K250143 Digital Prism Correction Feature (DPCF)
    K242058 Digital Prism Correction Feature (DPCF)
    K240929 Sleep Apnea Notification Feature (SANF)
    K231173 Irregular Rhythm Notification Feature (IRNF)
    K213971 Atrial Fibrillation History Feature
    K212516 IRNF App
    K201525 ECG App
    DEN180044 ECG App
    Search all 12 clearances from Apple, Inc. →