BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Sonova USA Inc.

    Reg #: 3008848788 · FEI: 3008848788 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    156
    Establishment Types
    3
    Classifications
    5

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    Registration Details

    Registration Name
    Sonova USA Inc.
    Registration Number
    3008848788
    FEI Number
    3008848788
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    444 Commerce Street
    City
    Aurora
    State
    IL
    ZIP
    60504
    Country
    US

    Regulatory Submissions

    510(k) Number
    K230538

    Owner / Operator

    Firm Name
    Sonova AG
    Operator Number
    9028479
    Address
    Laubisruetistrasse 28
    City
    Staefa
    State
    Zurich
    Postal Code
    8712
    Country
    CH

    Products

    Device Name Product Code
    Hearing Aid, Air-Conduction With Wireless Technology, Prescription OSM
    Self-Fitting Air-Conduction Hearing Aid, Over The Counter QUH
    Device, Assistive Listening LZI
    Masker, Tinnitus KLW
    Hearing Aid, Air-Conduction, Prescription ESD

    Proprietary Names

    Moxi S-RX Unitron ChargerGO RIC S-RX Easy Line ChargerGO RIC S-RX Terra+ RIC-R Terra BTE-SP Unitron Charger ITE Phonak Slim L-R HANSATON stream remote MEMINI E 5 P R-R AI PH ampli-charge R 3 Phonak Audeo L-R Fit Moxi S Phonak Naida M Vista DX ampli-energy B Trial L Stride B Aura:fit Relate Sennheiser S Charger R Easy Line ChargerGo RIC S Star Evolution ampli-mini E 5P R-R AI PH MECHARGE RIC 5P AudioNova S Vista B ampli-mini E D 5P R-R AI PH MECHARGE RIC 5P FP AudioNova B RELATE 2 Roger Neckloop DX Stride M Phonak Audeo I Vista T Relate3.1 Phonak Audeo M Relate 5 Phonak Charger RIC I Unitron Charger Moxi R 3 AudioNova DX Moxi RS charger Remote Control AudioNova DX Stride P R Easy Line ChargerCombi BTE2 Phonak Audeo P T Max Stride V Phonak Virto P Sennheiser Sonite Rise Charger Go Au Basic+ T Moxi Phonak Sky L Au V Phonak Virto M Sennheiser Sonite R Easy Line V charger AudioNova T Insera B Phonak Sky M Sonite R Kit Terra+ RIC-312 Easy Line Charger ITE Easy Line RS charger HelloGO Phonak CROS P ampli-energy R 5P R PH Phonak Virto I Moxi V Phonak Naida Link CROS Easy Line Remote Terra+ BTE-M Terra RIC-312 Roger X Moxi V-R/RT charger Phonak CROS L Phonak Naida L-M Terra BTE-M Terra+ BTE-UP Phonak ChargerGo RICSPH I AudioNova V charger Phonak Bolero M Sonite Rise ampli-energy R Trial 5P Insera S-R Vista V Phonak Naida Link myPhonak ampli-charge R AI 3 5P FP Au 3 MEMINI E D 5P R-R AI PH Phonak Charger Virto I Vista S Moxi B Unitron Charger Combi BTE 2 Phonak Audeo P-R Fit Terra+ BTE-SP ampli-connect R L PH Relate5 ITE R AudioNova V Unitron Remote Plus myPhonak Junior Au B Hearing Remote Phonak CROS I Phonak Naida L Au A Phonak Audeo I-Sphere T Insera Relate4 Naida CI Connect Terra BTE-UP DX Insera ampli-energy B L RP PH Relate3 Phonak Target ampli-connect R Trial L Easy Line Charger RIC S Phonak Brio 5 I Aura:fit AudioNova MEMINI E 5P R-R PH T Stride Phonak Audeo P-RL Unitron Charger RIC S Phonak Slim P-R Unitron ChargerGo RIC S Phonak Brio 5 Move Aura:fit Phonak ChargerGo RIC I Phonak RemoteControl Phonak Sky Link M Phonak Naida Link M ampli-mini R L PH Phonak Audeo L Unitron TrueFit Easy Line Charger RIC 3 Charger Easy Line Remote Control Easy Line Phonak Naida P All-Day Clear ADC1 Hearing Aid All-Day Clear Slim ADCS1 Hearing Aid Roger Focus II ampli-mini I 5P CIC-10 NWL PH Insera S-10 NW O MEMINI I 5P CIC-10 NWL PH MEMINI E P R-R PH Sonite Rise Charger Go EasyView Otoblock Lyric SoundLync kit Lyric sizing and fitting kit Titanium FitGuide Phonak Lyric4 Relate5 ITE 10 NW O Star Eclipse Roger 20 Roger 21 Unitron Shine Rev Lyric programming wand Lyric insertion tool

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Manufacture Medical Device