BEUDAMED
    FDA Registration Active 🇺🇸 United States

    hearX USA

    Reg #: 3015246392 · FEI: 3015246392 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    15
    Establishment Types
    4
    Classifications
    6

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    Registration Details

    Registration Name
    hearX USA
    Registration Number
    3015246392
    FEI Number
    3015246392
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    320 Dietz Ave
    City
    Dekalb
    State
    IL
    ZIP
    60115
    Country
    US

    Regulatory Submissions

    510(k) Number
    K223137

    Owner / Operator

    Firm Name
    hearX
    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
    Jade Blanchard

    Products

    Device Name Product Code
    Self-Fitting Air-Conduction Hearing Aid, Over The Counter QUH
    Self-Fitting Air-Conduction Hearing Aid, Prescription QDD
    Otoscope ERA
    Audiometer EWO
    Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter QUG
    Hearing Aid, Air-Conduction, Over The Counter QUF

    Proprietary Names

    Lexie B3 Hearing Aids Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application Lexie B2 Plus Self-fitting OTC Hearing Aids, Powered by Bose Lexie B2 Self-fitting OTC Hearing Aids, Powered by Bose Lexie B1 Self-fitting OTC Hearing Aids, Powered by Bose hearScope hearTest OccHealth hearScreen USA hearTest STK hearScreen Lexie H1 OTC Hearing Buds Go Ultra OTC Hearing Aids hearOAE Go Prime OTC Hearing Aids

    Establishment Types

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