BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Lexie B2 Self-fitting OTC Hearing Aids, Powered by Bose

    Reg #: 3015246392 · FEI: 3015246392 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    hearX USA
    Registration Number
    3015246392
    FEI Number
    3015246392
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2140 South DuPont Highway, Camden, Kent County
    City
    Camden
    State
    DE
    ZIP
    19934
    Country
    US

    Regulatory Submissions

    510(k) Number
    K211008

    Owner / Operator

    Firm Name
    hearX Group
    Operator Number
    10057906
    Address
    Ground Floor, Building 2, Ashlea Gardens Office Park,, 180 Garsfontein Road, Ashlea Gardens
    City
    Pretoria
    State
    Gauteng
    Postal Code
    0081
    Country
    ZA
    Correspondent
    Seline van der Wat

    Products

    Device Name Product Code
    Self-Fitting Air-Conduction Hearing Aid, Prescription QDD
    Self-Fitting Air-Conduction Hearing Aid, Over The Counter QUH

    Proprietary Names

    Lexie B2 Self-fitting OTC Hearing Aids, Powered by Bose Lexie B2 Plus Self-fitting OTC Hearing Aids, Powered by Bose Lexie B1 Self-fitting OTC Hearing Aids, Powered by Bose

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility