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510(k) Data Aggregation

    K Number
    K972106
    Device Name
    PHONAK NOVO FORTE E3
    Manufacturer
    Date Cleared
    1997-08-15

    (71 days)

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

    PHONAK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    General Indications: A. The indication for use of the air conduction hearing aids in this submission is to amplify sound far individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): Severity: 1. Slight, X 2. Mild, X 3. Moderate, X 4. Severe, 5. Profound. Configuration: X 1. High Frequency - Precipitously Sloping, X 2. Gradually Sloping, X 3. Reverse Slope, X 4. Flat, 5. Other. Other: X 1. Low tolerance To Loudness, 2., 3. B. Specific Indications (only if appropriate.): (Most psychoacuustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.) - l. 2. - 3.
    Device Description
    Programmable behind-the-ear hearing instrument. Substantially equivalent to other programmable behind-the-ear hearing instruments
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    K Number
    K972105
    Device Name
    PHONAK EPICA
    Manufacturer
    Date Cleared
    1997-08-01

    (57 days)

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

    PHONAK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The indication for use of the air conduction hearing aids in this submission is to amplify sound far individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): Severity: Slight, Mild, Moderate, Severe Configuration: High Frequency - Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat Other: Low tolerance To Loudness
    Device Description
    Programmable in-the-canal hearing instrument. Substantially equivalent to other programmable in-the-canal hearing instruments. Features: Two programmable memories, 3 choices of signal processing, optional remote control Assembly: Assembled from components available to hearing instruments manufacturer. Delivered completely assembled to the hearing aid dispenser Technical Characteristics: Technical specifications comply with ANSI S3.22 - 1987 Audiometric Fit: Frequency response, gain, and output are fitted to the individual audiogram Controls: Operated with remote control Power Source: Standard hearing instrument battery, size 312
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    K Number
    K972097
    Device Name
    PHONAK MICROZOOM P 2
    Manufacturer
    Date Cleared
    1997-07-30

    (56 days)

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

    PHONAK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The indication for use of the air conduction hearing aids in this submission is to amplify sound far individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): Severity: X 1. Slight X 2. Mild X 3. Moderate X 4. Severe Configuration: X 1. High Frequency - Precipitously Sloping X 2. Gradually Sloping X 3. Reverse Slope X 4. Flat Other X 1. Low tolerance To Loudness
    Device Description
    Programmable in-the-canal hearing instrument. Substantially equivalent to other programmable in-the-canal hearing instruments
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    K Number
    K964035
    Device Name
    PHONAK MICROLINK, PERSONAL FM RECEIVER
    Manufacturer
    Date Cleared
    1996-12-04

    (57 days)

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

    PHONAK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To receive FM transmission from a same channel transmitter/microphone and feed it to the hearing aid. An example of such use would be a lecture hall setting with user receiving direct imput from the person lecturing.
    Device Description
    Personal FM unit, operates only via audio input connection to Phonak BTE style hearing instruments. Substantially equivalent to other FM BTE systems.
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    K Number
    K961653
    Device Name
    PHONAK SONA P2
    Manufacturer
    Date Cleared
    1996-05-29

    (29 days)

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

    PHONAK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To amplify and transmit sound to the ear
    Device Description
    Programmable in-the-canal hearing instrument. Substantially equivalent to other programmable in-the-canal hearing instruments
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    K Number
    K961622
    Device Name
    PHONAK PICONET2 P2 AZ
    Manufacturer
    Date Cleared
    1996-05-17

    (21 days)

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

    PHONAK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To amplify and transmit sound to the ear
    Device Description
    Programmable behind-the-ear hearing instrument. Substantially equivalent to other programmable behind-the-ear hearing instruments
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