LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K972542
    Device Name
    JAZZ PP AGC-O, JAZZ PP
    Manufacturer
    TRUTONE
    Date Cleared
    1997-07-23

    (14 days)

    Product Code
    ESD
    Regulation Number
    874.3300
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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: Severe
    Configuration: Flat
    Other: Low tolerance To Loudness; JAZZ PP AGC-C

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a hearing aid device (Jazz PP AGC-C, Jazz PP) and focuses on substantial equivalence to a predicate device.

    It includes:

    • Regulatory information: Device name, 510(k) number, regulatory class, procode, and the date of clearance.
    • Substantial equivalence determination: The FDA's finding that the device is substantially equivalent to pre-amendments devices.
    • General controls provisions: A reminder of requirements like registration, listing, GMP, labeling, and prohibitions against misbranding/adulteration.
    • Warnings/Recommendations: Advice regarding electromagnetic interference from cellular phones and the need for possible future testing or labeling modifications.
    • Indications for Use: A description of the general and specific indications for which the hearing aid is intended (to amplify sound for individuals with impaired hearing, specifying severity and configuration of hearing loss).

    There is no mention of specific acceptance criteria (e.g., performance metrics, thresholds), a study design, sample sizes for test or training sets, expert qualifications, ground truth establishment methods, or whether a standalone or MRMC study was conducted.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1