BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    NU.EAR AE-1 IN THE EAR (ITE) HEARING AID

    K Number: K935332 · Decision Jan 21, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    1366
    Applicant Total
    10
    Review Days
    77

    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
    NU.EAR AE-1 IN THE EAR (ITE) HEARING AID
    K Number
    K935332
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3300
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nu-Ear Electronics
    Date Received
    November 5, 1993
    Decision Date
    January 21, 1994
    Product Code
    ESD
    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
    ESD Hearing Aid, Air-Conduction, Prescription

    Similar 510(k) Clearances

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

    Lyric4 Hearing Aid

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    LYRIC2

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    LYRIC HEARING AID

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    INSOUND XT SERIES HEARING AID

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat
    View all

    Other Clearances by Nu-Ear Electronics

    K Number Device Name
    K935331 NU.EAR SD-3 IN THE CANAL (ITC) HEARING AID
    K935328 NU.EAR SS-2 IN THE CANAL (ITC) HEARING AID
    K935335 NU.EAR SS-10 IN THE CANAL (ITC) HEARING AID
    K935329 NU.EAR AE-2 IN THE CANAL (ITC) HEARING AID
    K935327 NU.EAR SD-2 IN-THE-CANAL (ITC) HEARING AID
    K935333 NU.EAR SS-1 IN THE EAR (ITE) HEARING AID
    K935334 NU.EAR SD-1 IN THE EAR (ITE) HEARING AID
    K935330 NU.EAR SS-3 IN THE CANAL (ITC) HEARING AID
    K935326 NU-EAR SD-10 IN THE CANAL HEARING AID