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510(k) Data Aggregation

    K Number
    K061459
    Device Name
    TRANQUIL TRI-BTE
    Manufacturer
    GENERAL HEARING INSTRUMENTS, INC.
    Date Cleared
    2006-06-30

    (35 days)

    Product Code
    KLW
    Regulation Number
    874.3400
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENERAL HEARING INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tranquil TRI-BTE is for use in sound therapy for tinnitus retraining therapy, masking, or other recognized forms of tinnitus treatment. Sound therapy should be used in concert with counseling from a physician, an audiologist or other qualified tinnitus specialists.
    Device Description
    Not Found
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    K Number
    K974751
    Device Name
    TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC
    Manufacturer
    GENERAL HEARING INSTRUMENTS, INC.
    Date Cleared
    1998-03-06

    (77 days)

    Product Code
    ESD
    Regulation Number
    874.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENERAL HEARING INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A hearing Aid and/or Tinnitus Masker/Habituator. No hearing loss or a mild to severe high frequency hearing loss where the patient exhibits a low hearing loss where the patient's response to tinnitus is characterized by intolerance to specifically the inability to cope with head noises, anxiety, depression or the inability to function in daily life activities. When cosmetics are not an issue. A hearing Aid and/or Tinnitus Masker/Habituator. No hearing loss or a mild to severe high frequency hearing loss where the patient exhibits a low hearing loss when the patient's response to tinnitus is characterized by intolerance to specifically the inability to cope with head noises, anxiety, depression or the inability to function in daily life activities. When cosmetics are an issue. A hearing Aid and/or Tinnitus Masker/Habituator. No hearing loss or a mild to severe high frequency hearing loss where the patient exhibits a low hearing loss where the patient's response to tinnitus is characterized by intolerance to specifically the inability to cope with head noises, anxiety, depression or the inability to function in daily life activities. When cosmetics are a major issue.
    Device Description
    Tranquil TRI-OE: I-T-E hearing aid and/or tinnitus masker/habituator with Class A Noise Generator, Class D Noise Generator, DSD K-amp programmable or Intrigue Programmable. Assembled from standard components. Technical specifications comply with S3 2-1987 ANSI Standards. Frequency response dictated by individual audiogram. Volume control mechanical or electronic. Standard Size 312 battery. Tranquel TRI-COE: I-T-C hearing aid and/or tinnitus masker/habituator with Class A Noise Generator, Class D Noise Generator, DSD K-amp programmable or Intrigue Programmable. Assembled from standard components. Technical specifications comply with S3 2-1987 ANSI Standards. Frequency response dictated by individual audiogram. Volume control mechanical or electronic. Standard Size 10A battery. Tranquel TRI-CIC: C-I-C hearing aid and/or tinnitus masker/habituator with Class A Noise Generator, Class D Noise Generator, DSD K-amp programmable or Intrigue Programmable. Assembled from standard components. Technical specifications comply with S3 2-1987 ANSI Standards. Frequency response dictated by individual audiogram. Volume control mechanical or electronic. Standard Size 10A battery.
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    K Number
    K971399
    Device Name
    AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC
    Manufacturer
    GENERAL HEARING INSTRUMENTS, INC.
    Date Cleared
    1997-06-13

    (59 days)

    Product Code
    ESD
    Regulation Number
    874.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENERAL HEARING INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Mild to severe conductive, mixed or sensoryneural hearing loss Mild to severe conductive, mixed or sensoryneural hearing loss when cosmetics are of some concern Mild to moderate conductive, mixed or sensoryneural hearing loss when cosmetics are of major concern, but the ear can not accommodate a complete in the canal style Mild to moderate conductive, mixed or sensoryneural hearing loss when cosmetics are of major concern. Mild to severe conductive, mixed or sensoryneural hearing loss when a more cosmetic AE is desired. Mild to severe conductive, mixed or sensoryneural hearing loss when cosmetics are a major concern but the ear prevents use of a CIC or MM. Normal low and middle frequency hearing with a sloping mild to moderate high frequency sensory neural or mixed loss.
    Device Description
    To amplify and transmit sound to the ear. DSD K-amp or Intrigue programmable circuitry Assembled from standard components that are widely used by other hearing aid manufacturers. "Technical specifications comply with S3.2-1987 ANSI Standards" Frequency response dictated by individual audiogram Volume control similar to other devices. Standard size 13 battery Standard size 312 battery Standard size 10A battery Standard size 10a or 5a battery
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