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Data / Medical devices / United States / Cochlear Americas

Cochlear Americas: FDA-registered device maker in Lone Tree, CO, United States, 23 510(k) clearances and 5 PMA approvals

Cochlear Americas is registered with the FDA (registration 3005900820) in Lone Tree, CO, United States. It lists 14 device types. The FDA files 23 510(k) clearances and 5 PMA approvals under its listings, the newest dated July 10, 2026. 5 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Cochlear Americas
FDA registration number
3005900820
Address
10350 Park Meadows Drive, Lone Tree, CO, United States, 80124
Owner or operator
COCHLEAR AMERICAS (9076254)
Roles
Complaint file establishment
First device listed
March 7, 2003
Registered through
2027
Brand names listed
7M Magnet for CP1000 5(I) Coils, BA310 Abutment, BIA310 Implant/Abutment, BAHA IMPLANT SYSTEM, Ba400 14mm Abutment, Baha 5, Baha 5 Power, Baha 5 SuperPower Sound Processor, Baha 6 Max Sound Processor and more

Devices it lists

DeviceProduct codeClassRoleSource
Active Implantable Bone Conduction Hearing SystemPFO2Complaint file establishmentaccessdata.fda.gov
Cochlear Implant With Combined Electrical Stimulation And Acoustic AmplificationPGQ3Complaint file establishmentaccessdata.fda.gov
Device, Percutaneous, BiopsyMJG1Complaint file establishmentaccessdata.fda.gov
Disinfectant, Medical DevicesLRJ1Complaint file establishmentaccessdata.fda.gov
Hearing Aid, Air-Conduction With Wireless Technology, PrescriptionOSM2Complaint file establishmentaccessdata.fda.gov
Hearing Aid, Bone ConductionLXB2Complaint file establishmentaccessdata.fda.gov
Hearing Aid, Bone Conduction, ImplantedMAH2Complaint file establishmentaccessdata.fda.gov
Implant, Auditory BrainstemMHE3Complaint file establishmentaccessdata.fda.gov
Implant, CochlearMCM3Complaint file establishmentaccessdata.fda.gov
Instrument, Ent Manual SurgicalLRC1Complaint file establishmentaccessdata.fda.gov
Medical Device Data SystemOUG1Complaint file establishmentaccessdata.fda.gov
Motor, Surgical Instrument, Ac-PoweredGEY1Complaint file establishmentaccessdata.fda.gov
Prosthesis, Nose, InternalFZE2Complaint file establishmentaccessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other AccessoriesKCT2Complaint file establishmentaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 10, 2026K260902Cochlear™ Osia® 3(I) Sound Processor;Cochlear™ Osia® 3 Sound Processor;Cochlear™ Osia® 3 Charger;Cochlear™ Osia® 3 Aqua+;Cochlear™ Osia® Fitting Software 3;Cochlear™ Osia® Smart App;Cochlear™ Osia® SystemPFOSubstantially EquivalentCochlear Americasaccessdata.fda.gov
May 29, 2025K250215Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBandLXBSubstantially EquivalentCochlearaccessdata.fda.gov
August 24, 2023K231604Instrument CaseKCTSubstantially EquivalentCochlear Americasaccessdata.fda.gov
August 18, 2023K231204Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart AppPFOSubstantially EquivalentCochlearaccessdata.fda.gov
March 21, 2023K223672Instrument Case P1340904KCTSubstantially EquivalentCochlearaccessdata.fda.gov
July 27, 2022K220922Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI KitPFOSubstantially EquivalentCochlear Americasaccessdata.fda.gov
September 29, 2021K212136Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart AppLXBSubstantially EquivalentCochlear Americasaccessdata.fda.gov
February 23, 2021K202048Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart AppLXBSubstantially EquivalentCochlear Americasaccessdata.fda.gov
November 15, 2019K191921Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical InstrumentsPFOSubstantially EquivalentCochlear Americasaccessdata.fda.gov
July 3, 2019K190589Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical InstrumentsPFOSubstantially EquivalentCochlear Americasaccessdata.fda.gov
December 19, 2018K182116BA310 Abutment, BIA310 Implant/AbutmentMAHSubstantially EquivalentCochlear Americasaccessdata.fda.gov
June 7, 2017K171088Cochlear Baha SoundArcLXBSubstantially EquivalentCochlear Americasaccessdata.fda.gov
May 20, 2016K161123Baha 5 Power Sound ProcessorLXBSubstantially EquivalentCochlear Americasaccessdata.fda.gov
March 2, 2016K153245Baha 5 Super Power Sound ProcessorLXBSubstantially EquivalentCochlear Americasaccessdata.fda.gov
July 15, 2015K150555BA400 14mm AbutmentMAHSubstantially EquivalentCochlear Americasaccessdata.fda.gov
March 25, 2015K142907Baha 5 Sound ProcessorLXBSubstantially EquivalentCochlear Americasaccessdata.fda.gov
November 7, 2013K131240COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACTLXBSubstantially EquivalentCochlear Americasaccessdata.fda.gov
October 12, 2012K121317COCHLEAR BAHA IMPLANT SYSTEMMAHSubstantially EquivalentCochlear Americasaccessdata.fda.gov
July 13, 2010K100360BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENTLXBSubstantially EquivalentCochlear Americasaccessdata.fda.gov
October 17, 2000K002913HEADBAND FOR BAHALXBSubstantially EquivalentEntific Medical Systems, Inc.accessdata.fda.gov
November 24, 1999K992872BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE IILXBSubstantially EquivalentEntific Medical Systems, Inc.accessdata.fda.gov
August 9, 1996K955713NOBELPHARMA BONE ANCHORED HEARING AIDLXBSubstantially EquivalentNobelpharma USA, Inc.accessdata.fda.gov
January 13, 1995K945154BA-CPASFZESubstantially EquivalentNobelpharma USA, Inc.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
March 20, 2014P130016NUCLEUS HYBRID L24 COCHLEAR IMPLANT SYSTEMPGQ60September 28, 2026accessdata.fda.gov
October 20, 2000P000015NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEMMHE53September 28, 2026accessdata.fda.gov
June 25, 1998P970051NUCLEUS 24 COCHLEAR IMPLANT SYSTEMMCM225September 28, 2026accessdata.fda.gov
June 27, 1990P890027NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYS /CHILDRENMCM65September 28, 2026accessdata.fda.gov
October 31, 1985P840024NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESIMCM95September 28, 2026accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
December 18, 201883970Class IITerminatedCochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.)Product was packaged with the Incorrect tamper proof battery door.accessdata.fda.gov
June 5, 201571509Class IITerminatedCochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the sterile field to check the size of the periosteal pocket, the shape and depth of the implant well anCochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed.accessdata.fda.gov
April 9, 201468080Class IITerminatedCochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. For use with Baha Attract hearing system.Cochlear America is recalling Cochlear Baha Soft Tissue Gauge due to possible manufacturing imperfection in the smooth surface of the metal that could potentially leave residual metal on the patient's skin.accessdata.fda.gov
September 16, 201159979Not yet classifiedTerminatedCochlear Nucleus CI512 Cochlear Implant, REF Z209051, New with Nucleus 5, Sterile EO, Made in Australia, Cochlear Ltd 14 Mars Road, Lane Cove 2066, Australia. The cochlear implant is intended to restore a level of auditoCochlear implant may shut down and cease to function.accessdata.fda.gov
September 30, 200953492Not yet classifiedTerminatedNucleus Non-Magnetic Plug for removable magnet implants, REF Z50100, STERILE EO, Cochlear Limited.Cochlear implant device component was mis-labeled.accessdata.fda.gov

Compare with other makers

Updated September 28, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.