BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HEARING LAB TECHNOLOGY, LLC

    Reg #: 3012213704 · FEI: 3012213704 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    33
    Establishment Types
    4
    Classifications
    6

    Registration Details

    Registration Name
    HEARING LAB TECHNOLOGY, LLC
    Registration Number
    3012213704
    FEI Number
    3012213704
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    14301 FAA Blvd, Suite 105
    City
    Fort Worth
    State
    TX
    ZIP
    76155
    Country
    US

    Regulatory Submissions

    510(k) Number
    K930003

    Owner / Operator

    Firm Name
    Hearing Lab Technology, LLC
    Operator Number
    10052054
    Address
    14301 FAA Blvd, Suite 105, Suite A
    City
    Fort Worth
    State
    TX
    Postal Code
    76155
    Country
    US
    Correspondent
    Susan Reid

    Products

    Device Name Product Code
    Hearing Aid, Air-Conduction With Wireless Technology, Prescription OSM
    Cushion, Earphone (For Audiometric Testing) ETT
    Hearing Aid, Air-Conduction, Over The Counter QUF
    Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter QUG
    Hearing Aid, Air-Conduction, Prescription ESD
    Audiometer EWO

    Proprietary Names

    Elevate Engage Assure Liberty Liberty Engage Member's Selection Walker's America Hears Capsure Aspire Present Accent Freedom Ear Back Hearing Aid Model 456 Ear Back Hearing Aid Model 256 Ear Back Hearing Aid Model 556 Ear Back Hearing Aid Model 546 Ear Back Hearing Aid Model 557 Ear Back Hearing Aid Model 446 Ear Back Hearing Aid Model 756 Ear Back Hearing Aid Model 246 Ear Back Hearing Aid Model 746 Renew ER38-15 Eartips ER38-14 Eartips ER3-14 Eartips ER38-18 Eartips Enrich, Enrich Pro, Enlite, Enlite Plus Tala Engage, Engage Rechargeable, Fio Fio ER-3A Insert Earphones ER-3C Insert Earphones

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Manufacture Medical Device