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510(k) Data Aggregation

    K Number
    K973885
    Device Name
    OTICON DIGISOUND ITE
    Manufacturer
    OTICON, INC.
    Date Cleared
    1997-11-04

    (21 days)

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

    OTICON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A. General Indications: The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): Severity: 1. Slight ✓ 2. Mild ✓ 3. Moderate ✓ 4. Severe 5. Profound Configuration: 1. High Frequency - Precipitously Sloping ✓ 2. Gradually Sloping ✓ 3. Reverse Slope 4. Flat ✓ 5. Other Other 1. Low tolerance To Loudness ✓ 2. 3. B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise. must be supported by clinical data.) 1. To amplify and deliver sound to the ear via air conduction 2. 3.
    Device Description
    Not Found
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    K Number
    K973886
    Device Name
    OTICON DIGISOUND COMPACT
    Manufacturer
    OTICON, INC.
    Date Cleared
    1997-11-04

    (21 days)

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

    OTICON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A. General Indications: The indication for use of the air conduction hearing aids in this Submission is to amplify sound for individuals with impaired ability. These devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): Severity: 1. Slight ✓ 2. Mild ✓ 3. Moderate ✓ 4. Severe ✓ 5. Profound Configuration: 1. High Frequency - Precipitously Sloping ✓ 2. Gradually Sloping ✓ 3. Reverse Slope ✓ 4. Flat ✓ 5. Other Other 1. Low tolerance To Loudness ✓ 2. 3. B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.) 1. To amplify and deliver sound to the ear via air conduction 2. 3.
    Device Description
    Not Found
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    K Number
    K964683
    Device Name
    DIGIFOCUS ITE
    Manufacturer
    OTICON, INC.
    Date Cleared
    1996-12-12

    (20 days)

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

    OTICON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To amplify and deliver sound to the ear
    Device Description
    DigiFocus is a seven band, two channel fully automatic hearing instrument which utilizes true digital signal processing (DSP). True DSP allows for precise, seven band frequency shaping and a unique and complex compression system utilizing syllabic compression in the lower frequency channel (below 1500 Hz) and nonsyllabic compression in the higher frequency channel (above 1500Hz). 42 dB HFA gain. Assembled from standard electronic hearing aid components mounted together with custom microchips on flexfilm.
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    K Number
    K961059
    Device Name
    DIGIFOCUS COMPACT
    Manufacturer
    OTICON, INC.
    Date Cleared
    1996-05-07

    (50 days)

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

    OTICON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To amplify and deliver sound to the ear
    Device Description
    DigiFocus Compact (DFC) is a seven band, two channel fully automatic hearing instrument which utilizes true digital signal processing (DSP). True DSP allows for precise, seven band frequency shaping and a unique and complex compression system utilizing syllabic compression in the lower frequency channel (below 1500Hz) and nonsyllabic compression in the higher frequency channel (above 1500Hz). 54 dB HFA gain. Assembled from standard electronic hearing aid components mounted together with custom microchips on flexfilm. Technical specifications are in accordance with ANSI Standards S3.22-1987. Frequency response, compression threshold and ratio, gain and SSPL 90 is dictated by individual audiometric and patient history data. All parameters are digitally programmed via software. The hearing aid has a manual OTM switch. Standard type 13 battery.
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    K Number
    K960284
    Device Name
    OTICON /PRIMOFOCUS (PF)
    Manufacturer
    OTICON, INC.
    Date Cleared
    1996-03-07

    (48 days)

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

    OTICON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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