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510(k) Data Aggregation

    K Number
    K984243
    Device Name
    TELEX TINNITUS-COMPANION
    Manufacturer
    TELEX COMMUNICATIONS, INC.
    Date Cleared
    1999-01-21

    (55 days)

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

    TELEX COMMUNICATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    for use in treatment and control of tinnitus.
    Device Description
    non-occluding Ultra-helix type shell, two power levels assembled from standard components that are widely used by other hearing aid manufacturers. measured with Fonix™ 6500, 2cc coupler, "Spectrum Mode". typical frequency response as shown on specification filed with 510(k). Response can be tailored to the individual via audiological controls. Volume control, one Audiological Control (tone). Standard hearing aid battery (312)
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    K Number
    K982683
    Device Name
    TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION
    Manufacturer
    TELEX COMMUNICATIONS, INC.
    Date Cleared
    1998-10-06

    (67 days)

    Product Code
    EPF
    Regulation Number
    874.3320
    Why did this record match?
    Applicant Name (Manufacturer) :

    TELEX COMMUNICATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    to amplify and transmit sound to the ear. The indication for use of the air conduction hearing aids for 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 √, 2. Gradually Sloping √, 3. Reverse Slope √, 4. Flat √, 5. Other: Other: Low tolerance to Loudness The Telex Select 1-40 BTE FM System is best suited for students of middle school age and older who have a moderate to profound hearing loss. It may be appealing to older students that have rejected FM amplification because of the stigma associated with body-worn auditory trainers.
    Device Description
    assembled from standard components that are widely used by other hearing aid manufacturers. Technical characteristics: technical specifications comply with S3.2-1987 ANSI standards. Fit: frequency response per S3.2-1987 ANSI standard as shown on specification filed with 510(k). Controls: Volume control, Mode Switch, Audiological Controls (output and tone). Power: Standard hearing aid battery (675)
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    K Number
    K964639
    Device Name
    TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II
    Manufacturer
    TELEX COMMUNICATIONS, INC.
    Date Cleared
    1997-01-21

    (63 days)

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

    TELEX COMMUNICATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    to amplify and transmit sound to the ear.
    Device Description
    Intended use: to amplify and transmit sound to the ear. Features: Threshold Compression. 2-band compression. AC+ Assemblv: assembled from standard components that are widely used by other hearing aid manufacturers. Technical characteristics: technical specifications comply with S3.2-1987 ANSI standards. Fit: frequency response per S3.2-1987 ANSI standard as shown on specification filed with 510(k). Controls: Volume control, Low Band Gain (optional), High Band Gain (optional), Crossover Frequency (optional), Threshold Control, Loudness Boost (optional), Set-screw Volume Control (optional), Low cut Switch (optional) Standard hearing aid battery (13, 312, 10A or 5A) Power:
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    K Number
    K963915
    Device Name
    TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION
    Manufacturer
    TELEX COMMUNICATIONS, INC.
    Date Cleared
    1996-11-08

    (39 days)

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

    TELEX COMMUNICATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    to amplify and transmit sound to the ear.
    Device Description
    assembled from standard components that are widely used by other hearing aid manufacturers.
    Ask a Question
    K Number
    K961143
    Device Name
    TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40
    Manufacturer
    TELEX COMMUNICATIONS, INC.
    Date Cleared
    1996-05-07

    (47 days)

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

    TELEX COMMUNICATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    to amplify and transmit sound to the ear.
    Device Description
    assembled from standard components that are widely used by other hearing aid manufacturers.
    Ask a Question

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