Data / Medical devices / Australia / Cochlear Ltd

Cochlear Ltd: FDA-registered device maker in Macquarie University New South Wales, Australia, 6 510(k) clearances and 5 PMA approvals

Name: Cochlear Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Cochlear Ltd is registered with the FDA (registration 3009092818) in Macquarie University New South Wales, Australia. It lists 7 device types. The FDA files 6 510(k) clearances and 5 PMA approvals under its listings, the newest dated July 10, 2026. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3009092818
Address: 1 University Ave, Macquarie University New South Wales, Australia, 2109
Owner or operator: COCHLEAR AMERICAS (9076254)
Roles: Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer
First device listed: August 10, 2005
Registered through: 2027
Brand names listed: 7M Magnet for CP1000 5(I) Coils, Baha 5 SuperPower Sound Processor, Cochlear Nucleus 8 Nexa Sound Processor and Accessories, Cochlear Nucleus Kanso 3 Nexa Sound Processor and accessories, Cochlear Nucleus Kanso 3 Sound Processor and accessories, Cochlear Nucleus Nexa cochlear implants, Cochlear Objective Measures, Cochlear Osia 3 Aqua+ and more

Devices it lists

Device	Product code	Class	Role	Source
Active Implantable Bone Conduction Hearing System	PFO	2	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification	PGQ	3	Specification developer	accessdata.fda.gov
Hearing Aid, Bone Conduction	LXB	2	Exporter to the US	accessdata.fda.gov
Implant, Auditory Brainstem	MHE	3	Manufacturer, Specification developer	accessdata.fda.gov
Implant, Cochlear	MCM	3	Manufacturer, Specification developer	accessdata.fda.gov
Instrument, Ent Manual Surgical	LRC	1	Specification developer	accessdata.fda.gov
Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring	SEM	2	Contract manufacturer	accessdata.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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 10, 2026	K260902	Cochlear 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® System	PFO	Substantially Equivalent	Cochlear Americas	accessdata.fda.gov
August 18, 2023	K231204	Cochlear 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 App	PFO	Substantially Equivalent	Cochlear	accessdata.fda.gov
July 27, 2022	K220922	Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit	PFO	Substantially Equivalent	Cochlear Americas	accessdata.fda.gov
November 15, 2019	K191921	Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments	PFO	Substantially Equivalent	Cochlear Americas	accessdata.fda.gov
July 3, 2019	K190589	Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments	PFO	Substantially Equivalent	Cochlear Americas	accessdata.fda.gov
March 2, 2016	K153245	Baha 5 Super Power Sound Processor	LXB	Substantially Equivalent	Cochlear Americas	accessdata.fda.gov

PMA approvals

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

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
March 20, 2014	P130016	NUCLEUS HYBRID L24 COCHLEAR IMPLANT SYSTEM	PGQ	60	September 28, 2026	accessdata.fda.gov
October 20, 2000	P000015	NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM	MHE	53	September 28, 2026	accessdata.fda.gov
June 25, 1998	P970051	NUCLEUS 24 COCHLEAR IMPLANT SYSTEM	MCM	225	September 28, 2026	accessdata.fda.gov
June 27, 1990	P890027	NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYS /CHILDREN	MCM	65	September 28, 2026	accessdata.fda.gov
October 31, 1985	P840024	NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI	MCM	95	September 28, 2026	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.