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Cochlear Americas

Last updated September 17, 2026

Information

Country: US
Address: 10350 Park Meadows Drive, Lone Tree, CO, 80124
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3005900820
DUNS Number: —

Catalogue (32)

Device	Model / Reference	Registries	Class	Status
Field Bone-Anchored Drill Kit	91053R	FDA UDI	Class II	Active
Rental Bone-Anchored Drill Kit	FUZ180	FDA UDI	Class II	Active
Custom Sound Pro 7.0 Cd	P2002452CD	FDA UDI	Class III	Active
Baha Fitting Software 5 Cd	P803255CD	FDA UDI	Class II	Active
Baha Fitting Software 6 Cd	P1682914CD	FDA UDI	Class II	Active
Osia Fitting Software 2 Cd	P1348428CD	FDA UDI	Class II	Active
Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App	K202048	FDA 510(k)	Class II	Active
Cochlear Osia System	K240155	FDA 510(k)	Class II	Active
Bia300 Series Implant And Abutment, Bi300 Implant, Ba300 Abutment	K100360	FDA 510(k)	Class II	Active
Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App	K212136	FDA 510(k)	Class II	Active
Cochlear Baha Implant System, Cochlear Baha Attract	K131240	FDA 510(k)	Class II	Active
Cochlear Baha 4 Sound Processor	K132278	FDA 510(k)	Class II	Active
Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments	K191921	FDA 510(k)	Class II	Active
BA400 14mm Abutment	K150555	FDA 510(k)	Class II	Active
Baha 5 Sound Processor	K142907	FDA 510(k)	Class II	Active
Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit	K220922	FDA 510(k)	Class II	Active
BA310 Abutment, BIA310 Implant/Abutment	K182116	FDA 510(k)	Class II	Active
Cochlear Baha Implant System	K121317	FDA 510(k)	Class II	Active
Baha 5 Super Power Sound Processor	K153245	FDA 510(k)	Class II	Active
Cochlear Baha SoundArc	K171088	FDA 510(k)	Class II	Active
Baha Intenso	K081606	FDA 510(k)	Class II	Active
Instrument Case	K231604	FDA 510(k)	Class II	Active
Cordelle II Sound Processor	K150751	FDA 510(k)	Class II	Active
Baha 5 Power Sound Processor	K161123	FDA 510(k)	Class II	Active
Baha 3 Power Sound Processor	K110996	FDA 510(k)	Class II	Active
Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments	K190589	FDA 510(k)	Class II	Active
3m Brand Cochlear Implant System/House Design	P830069	FDA PMA	Class III	Active
Nucleus Hybrid L24 Cochlear Implant System	P130016	FDA PMA	Class III	Active
Nucleus Auditory Brainstem Implant System	P000015	FDA PMA	Class III	Active
Nucleus 22 Channel Cochlear Implant For Children	P890027	FDA PMA	Class III	Active
Nucleus 22 Cochlear Implant System For Adults/Esprit 22	P840024	FDA PMA	Class III	Active
Nucleus 24 Cochlear Implant System	P970051	FDA PMA	Class III	Active

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FDA Recalls (5)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Dec 18, 2018	Z-0792-2020	—	terminated	Product was packaged with the Incorrect tamper proof battery door.
Jun 5, 2015	Z-2155-2015	—	terminated	Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed.
Apr 9, 2014	Z-1699-2014	—	terminated	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.
Sep 16, 2011	Z-0003-2012	—	terminated	Cochlear implant may shut down and cease to function.
Sep 30, 2009	Z-0119-2010	—	terminated	Cochlear implant device component was mis-labeled.