BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EARLENS CORPORATION

    Reg #: 3010863048 · FEI: 3010863048 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    EARLENS CORPORATION
    Registration Number
    3010863048
    FEI Number
    3010863048
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1165 O'Brien Dr
    City
    Menlo Park
    State
    CA
    ZIP
    94025
    Country
    US

    Regulatory Submissions

    510(k) Number
    K182480

    Owner / Operator

    Firm Name
    Earlens Corporation
    Operator Number
    10050793
    Address
    1165 O'Brien Dr
    City
    Menlo Park
    State
    CA
    Postal Code
    94025
    Country
    US
    Correspondent
    Simin Shamsfallah

    Products

    Device Name Product Code
    Tympanic Membrane Direct Contact Hearing Aid PLK
    Kit, Earmold, Impression LDG

    Proprietary Names

    Earlens Contact Hearing Solution, Tympanic Lens, Ear Tip, Processor, Charger, Earlens Fitting Software Hybrid Impression Kit, Impression Dispenser, Impression Cartridges (Lateral & Medial), Dispensing Tips, Mixing Tips

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device