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510(k) Data Aggregation

    K Number
    K201370
    Device Name
    Multiflex Tinnitus Technology
    Manufacturer
    Starkey Laboratories, Inc.
    Date Cleared
    2020-06-19

    (28 days)

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

    Starkey Laboratories, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Multiflex Tinnitus Technology is a tool to generate sounds to be used in a Tinnitus Management Program to relieve patients suffering from tinnitus. The target population is primarily the adult population over 18 years of age. The Multiflex Tinnitus Technology is targeted for healthcare professionals, which are treating patients suffering from tinnitus, as well as conventional hearing disorders. The fitting of the Multiflex Tinnitus Technology must be done by a hearing professional participating in a Tinnitus Management Program.
    Device Description
    Multiflex Tinnitus TechnologyTM (Tinnitus Multiflex) is designed to generate noise that can optionally periodically fluctuate in amplitude and frequency to provide relief for patients suffering from tinnitus. Tinnitus Multiflex is a firmware program code (algorithm) that is embedded as part of the integrated circuit (IC) in the Digital Signal Processing (DSP) stage of a hearing-aid. More specifically, Tinnitus Multiflex is an added branch of code that is separate from the normal existing hearing-aid firmware. As such, hearing-aid operating characteristics (besides tinnitus-stimulus functionalities) are not impacted by the Tinnitus Multiflex branch of code. Tinnitus Multiflex may be deployed across all Starkey hearing-aid models. Tinnitus Multiflex functionalities and parameters are enabled and adjusted by a hearing-care professional utilizing the Starkey proprietary hearing-aid programming software, Inspire. The Tinnitus Multiflex can be manually adjusted to a patient's stimulus needs or automatically adjusted via the new audiogram shaping functionality.
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    K Number
    K122876
    Device Name
    MULTIFLEX TINNITUS TECHNOLOGY
    Manufacturer
    STARKEY LABORATORIES
    Date Cleared
    2012-10-31

    (42 days)

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

    STARKEY LABORATORIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Multiflex Tinnitus Technology™ is a tool to generate sounds to be used in a Tinnitus Management Program to relieve patients suffering from tinnitus. The target population is primarily the adult population over 18 years of age. The Multiflex Tinnitus Technology™ is targeted for healthcare professionals, which are treating patients suffering from tinnitus, as well as conventional hearing disorders. The ncating patients barrering from themnology™ must be done by a hearing professional participating in a Tinnitus Management Program.
    Device Description
    The Starkey Multiflex Tinnitus Technology™ provides the hearing care professional with an option to treat those patients suffering from tinnitus. It is a firmware functionality option embedded in the signal processing stage of a digital hearing aid. The Multiflex Tinnitus Technology™ firmware generates broadband white noise that periodically fluctuates in amplitude and frequency to provide relief for those suffering from timitus. The Multiflex Tinnitus Technology™ functionalities and parameters are enabled and adjusted by a hearing care professional to meet the individual needs of the patient.
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    K Number
    K030180
    Device Name
    CRESCENT TINNITUS RETAINING SOUND GENERATOR
    Manufacturer
    STARKEY LABORATORIES, INC.
    Date Cleared
    2003-09-17

    (243 days)

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

    STARKEY LABORATORIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Crescent Sound Generator is an electronic, air-conduction broadband noise generator intended to generate noise of sufficient intensity and bandwidth to be used for tinnitus masking therapy. The Crescent Sound Generator is intended to be used by those individuals who experience tinnitus, and do not need or desire amplification. The intended use of this device includes it's fitting by a qualified audiologist or other hearing healthcare professional familiar with the diagnosis and treatment of tinnitus.
    Device Description
    The Crescent Sound Generator is an electronic, air-conduction broadband noise generator intended to generate noise of sufficient intensity and bandwidth to be used for tinnitus masking therapy.
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    K Number
    K970952
    Device Name
    PRECISE IMPRESSION KIT
    Manufacturer
    STARKEY LABORATORIES, INC.
    Date Cleared
    1997-05-02

    (49 days)

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

    STARKEY LABORATORIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To obtain an accurate imprint of an individual ear and ear canal.
    Device Description
    Precise Impression Kit. Impression Kits, -- Substantially equivalent to the Silhouette™ Premium Impression System from Siemens Hearing Instruments, Inc. and the Matrics Impression System from Matrics, Inc.
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    K Number
    K964245
    Device Name
    PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS
    Manufacturer
    STARKEY LABORATORIES, INC.
    Date Cleared
    1997-02-04

    (103 days)

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

    STARKEY LABORATORIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To obtain an accurate imprint of an individual ear and ear canal.
    Device Description
    The above mentioned impression kits are designed to provide the tools necessary for a Hearing Health Professional to obtain an accurate imprint of an individual ear and ear canal. The Hearing Health Professional receives materials in the form of a kit, and is responsible for any mixing of materials, or assembly of components for usage.
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    K Number
    K964340
    Device Name
    PORTAREM-3000, PFS-6000
    Manufacturer
    STARKEY LABORATORIES, INC.
    Date Cleared
    1997-01-10

    (71 days)

    Product Code
    EWO
    Regulation Number
    874.1050
    Why did this record match?
    Applicant Name (Manufacturer) :

    STARKEY LABORATORIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The portaREM-3000,PFS-6000 is a portable hearing aid dispensing system which allows the Hearing Health Care Professional to test hearing aids to IEC/ANSI standards. It also allows for Real Ear testing, and In Situ Audiometry via the use of the probe microphone, and offers a 2cc coupler conversion in which the 2cc coupler response desired can be determined from the audiogram. Standard puretone measurement is also available. With the PFS software, which will be standard with PFS-6000 and optional for the pR-3000, prescriptive formulas, matrix and hearing aid selection, order form printing, along with other optiions described in the user manual are available.
    Device Description
    The portaREM-3000, PFS-6000 is a portable hearing aid dispensing system. It includes electronic circuitry, a 4.7" color LCD monitor with 640*480 resolution, a built-in Thermoprinter, a loudspeaker, a 3.5 inch disk drive, a test chamber for hearing aid measurement, a battery simulator, two RS-232 serial port interfaces, and a real ear probe mic. It is controlled by a fully functional PC style keyboard.
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    K Number
    K964216
    Device Name
    STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER
    Manufacturer
    STARKEY LABORATORIES, INC.
    Date Cleared
    1996-12-06

    (45 days)

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

    STARKEY LABORATORIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To generate a pleasant white noise stimulus to aid in masking the user's tinnitus (or ringing in the ears)
    Device Description
    The Starkey TM air conduction high frequency tinnitus maskers are designed to be behind-the-ear maskers. This form of masker is intended to be received by a Hearing Health Professional in a completed form, not being intended for final assembly. The Starkey TMs are BTE Tinnitus Maskers with a white noise generating circuit which can be tuned to match the frequency and intensity of ringing in the patient's ears (head). The patient has a volume control for this circuit. Variable high and low frequency cut potentiometers can be set by a Dispenser to tune to more specific frequencies.
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    K Number
    K964214
    Device Name
    STARKEY A-13 SEQUEL PROGRAMMABLE, A-13 K-AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS
    Manufacturer
    STARKEY LABORATORIES, INC.
    Date Cleared
    1996-11-27

    (36 days)

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

    STARKEY LABORATORIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To assist in compensating for hearing loss by amplifying sound as it comes into the ear.
    Device Description
    The Starkey A-13 air conduction hearing aids are designed to be behind-the-ear hearing aids. This form of hearing aid is intended to be received by a Hearing Health Professional in a completed form, not being intended for final assembly.
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    K Number
    K964244
    Device Name
    STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS
    Manufacturer
    STARKEY LABORATORIES, INC.
    Date Cleared
    1996-11-27

    (34 days)

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

    STARKEY LABORATORIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To assist in compensating for hearing loss by amplifying sound pressure waves as they enter the ear.
    Device Description
    Custom fit air conduction hearing aids available as ITE, ITC, or CIC -- Substantially equivalent to the Starkey CE-9 Resolution programmable hearing aid, (K933989). Adjustable hearing aid volume control, color coding for left and right instruments, 6 programmable options: Low cut, High cut, Gain control, Compression ratio, Threshold knee, and Output limiting for Sequel, or Loudness Boost for K Amp. Assembled from standard components that are widely used in hearing aid devices throughout the industry. Technical specifications comply with ANSI S3.22-1987. Frequency response varying based on the needs of the patient. Tolerances are maintained to a ± 4 dB range for SSPL and slope, with +6 dB, -4 dB for gain. Volume controls, similar to those used on other hearing aid devices. Switches may be incorporated as options require. Any switches are similar to those used in other hearing aid devices. Standard hearing aid batteries.
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    K Number
    K963838
    Device Name
    STARKEY TM AIR CONDUCTION TINNITUS MASKER
    Manufacturer
    STARKEY LABORATORIES, INC.
    Date Cleared
    1996-11-26

    (63 days)

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

    STARKEY LABORATORIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To generate and transmit a pleasant white noise stimulus to aid in masking the user's tinnitus (or ringing in the ears)
    Device Description
    Custom fit air conduction Tinnitus Masker
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