BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Sontro Self-Fitting OTC Hearing Aids

    Reg #: 3015527983 · FEI: 3015527983 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SOUNDWAVE HEARING, LLC
    Registration Number
    3015527983
    FEI Number
    3015527983
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    619 Enterprise Dr Ste 205
    City
    Oak Brook
    State
    IL
    ZIP
    60523
    Country
    US

    Regulatory Submissions

    510(k) Number
    K231550

    Owner / Operator

    Firm Name
    Soundwave Hearing, LLC
    Operator Number
    10060266
    Address
    619 Enterprise Dr Ste 205
    City
    Oak Brook
    State
    IL
    Postal Code
    60523
    Country
    US
    Correspondent
    Anthony Florek

    Products

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

    Proprietary Names

    Sontro Self-Fitting OTC Hearing Aids Accessory-Sport Lock otoTune app (for Android) Accessory-Receiver-In-Canal otoTune app (for iOS) Accessory-Ear Dome

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility