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510(k) Data Aggregation

    K Number
    K974338
    Device Name
    UNITRON MODEL F/X PROGRAMMABLE (MINI BTE)
    Date Cleared
    1997-12-12

    (24 days)

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

    UNITRON INDUSTRIES, 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 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.
    Device Description
    Unitron Model Sound F/X Programmable Mini BTE Hearing Aid
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    K Number
    K974339
    Device Name
    UNITRON MODEL SOUND F/XD PROGRAMMABLE
    Date Cleared
    1997-12-12

    (24 days)

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

    UNITRON INDUSTRIES, 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 for 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, Profound Configuration: High Frequency -Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat, Other Other: Low Tolerance to loudness
    Device Description
    Sound F/XD Programmable Mini BTE Unitron Industries, Inc.
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    K Number
    K974340
    Device Name
    UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE
    Date Cleared
    1997-12-12

    (24 days)

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

    UNITRON INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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: ✓ 2. Mild ✓ 3. Moderate ✓ 4. Severe Configuration: ✓ 1. High Frequency -Precipitously Sloping ✓ 2. Gradually Sloping ✓ 3. Reverse Slope ✓ 4. Flat
    Device Description
    Sound F/XP Programmble Mini BTE Hearing Aid
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    K Number
    K970692
    Device Name
    UNITRON MODEL SOUND F/X CIC
    Date Cleared
    1997-05-08

    (72 days)

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

    UNITRON INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To amplify and transmit sound via air conduction to the ear.
    Device Description
    Completely-In-The-Canal Hearing Aid. Substantially equivalent to other Completely-In-The-Canal hearing aids. Features: Two channel wide dynamic range compression. Six adjustable parameters: Low-channel Gain, High-channel Gain, See-Saw, Cross Over Frequency, Threshold Knee-point and power. Twin average compression detectors. Class D Circuitry for excellent battery life. Assembled from standard components that are used by Unitron and other hearing aid manufacturers. Technical specifications comply with ANSI Standard S 3.22-1987. Controls: Screw set Volume Control, similar to other CIC devices. Power: Standard hearing aid battery - size 10A or 5A. A user's manual and other information is supplied with each hearing aid.
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    K Number
    K970519
    Device Name
    UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE)
    Date Cleared
    1997-04-24

    (72 days)

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

    UNITRON INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To amplify and transmit sound via air conduction to the ear .
    Device Description
    Sound F/X Programmable In-The-Ear Programmable Hearing Aid. Five programmable parameters: Low-channel Gain, High-channel Gain, Cross-over Frequency, Threshold Kneepoint, Power. Two channels with wide dynamic range compression circuitry independently adjustable for each channel. Twin average compression detectors. Class D circuitry for excellent battery life. Assembled from standard components that are used by Unitron and other hearing aid manufacturers. Technical Specifications comply with ANSI Standard S 3.22-1987. Volume Control, similar to other devices. Standard hearing aid battery size 13, 312 or 10A.
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    K Number
    K964502
    Device Name
    UNITRON MODEL SOUND F/XP +4
    Date Cleared
    1996-11-27

    (19 days)

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

    UNITRON INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To amplify and transmit sound via air conduction to the ear.
    Device Description
    Behind-The-Ear Hearing Aid. Substantially equivalent Type of Device: to other behind-the-ear hearing aids. Features: Three fitter controls - Cross over frequency, low channel gain, and threshold knee point. Two channel compression circuitry. Class D circuitry for excellent battery life. Telecoil with pre-amplifier. Assembly: Assembled from standard components that are used by Unitron and other hearing aid manufacturers. Technical Characteristics: Technical specifications comply with ANSI Standard S 3.22-1987. Fit: Hearing aid adjustment dictated by individual audiogram. Volume control, similar to other devices. Switch for Controls: selecting microphone, telecoil and off. Power : Standard hearing aid battery - size 13.
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    K Number
    K964503
    Device Name
    UNITRON MODEL SOUND F/X +4
    Date Cleared
    1996-11-27

    (19 days)

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

    UNITRON INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To amplify and transmit sound via air conduction to the ear.
    Device Description
    Behind-The-Ear Hearing Aid. Assembled from standard components that are used by Unitron and other hearing aid manufacturers.
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    K Number
    K964504
    Device Name
    UNITRON MODEL ICON AOHPL +4
    Date Cleared
    1996-11-27

    (19 days)

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

    UNITRON INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To amplify and transmit sound via air conduction to the ear.
    Device Description
    Behind-The-Ear Hearing Aids. Four fitter controls Power, Compression Limiting, active low cut tone, high cut tone. Class D circuitry for excellent battery life. Powerful telecoil with preamplifier. Assembled from standard components that are used by Unitron and other hearing aid manufacturers. Technical specifications comply with ANSI Standard S 3.22-1987. Volume control, similar to other devices. Switch for selecting microphone, telecoil and off. Standard hearing aid battery size 13.
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    K Number
    K964508
    Device Name
    UNITRON MODEL ICON AOHP +4 (ICON AOHP +4)
    Date Cleared
    1996-11-27

    (19 days)

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

    UNITRON INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To amplify and transmitt sound via air conduction to the ear.
    Device Description
    Behind-The-Ear Hearing Aids. Substantially equivalent to other behind-the-ear hearing aids. Four fitter controls - Power, Compression Limiting, active low cut tone, high cut tone. Class D circuitry for excellent battery life. Powerful telecoil with preamplifier. Assembled from standard components that are used by Unitron and other hearing aid manufacturers. Technical specifications comply with ANSI Standard S 3.22-1987. Volume Control, similar to other devices. Switch for selecting microphone, telecoil and off. Standard hearing aid battery - size 13.
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    K Number
    K964510
    Device Name
    UNITRON MODEL ICON AOHPD +4 (ICON AOHPD +4)
    Date Cleared
    1996-11-27

    (19 days)

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

    UNITRON INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To amplify and transmit sound via air conduction to the ear .
    Device Description
    Behind-The-Ear Hearing Aids. Substantially equivalent to other behind-the-ear hearing aids. Features: Four fitter controls - Power, Compression Limiting, active low cut tone, high cut tone. Class D circuitry for excellent battery life. Powerful telecoil with preamplifier. Directional microphone. Assembled from standard components that are used by Unitron and other hearing aid manufacturers.
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