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

    IN-THE-EAR HEARING AIDS

    K Number: K913366 · Decision Nov 5, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    1366
    Applicant Total
    2
    Review Days
    99

    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
    IN-THE-EAR HEARING AIDS
    K Number
    K913366
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3300
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Fenwick Hearing Instruments
    Date Received
    July 29, 1991
    Decision Date
    November 5, 1991
    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 Fenwick Hearing Instruments

    K Number Device Name
    K963047 AIR-CONDUCTION HEARING INSTRUMENTS: MODELS = 227, 229, 232, 216, 216P, 123, 219 (MODIFY)