Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9613646

FEI Number

3003045432

Entity Name

Cochlear Limited - Brisbane

City/State/Country

Newstead Queensland, AU

Establishment Address

12 Helen Street, Newstead Queensland 4006, AU

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

COCHLEAR AMERICAS (Owner Number: 9076254)

Owner / Operator Contact Address

10350 Park Meadows Drive, Lone Tree, CO 80124, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P890027

All Registered Proprietary Names

Baha 5 SuperPower Sound Processor Cochlear OsiaTM System NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Cochlear Surgical Instrument Upgrade Kit Nucleus SmartNav Cochlear Nucleus Kanso 3 Nexa Sound Processor and accessories Cochlear Nucleus 8 Nexa Sound Processor and Accessories Cochlear Nucleus Nexa cochlear implants Cochlear Nucleus Kanso 3 Sound Processor and accessories Nucleus Smart App Cochlear Objective Measures Cochlear surgical processors and accessories Custom Sound Pro N22 COCHLEAR IMPLANT SYS FOR ADULTS ENT Surgical Nucleus Auditory Brainstem Implant System N22 COCHLEAR IMPLANT SYS FOR PED

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	Class 2	874.3302	2016-03-02
PFO	Active Implantable Bone Conduction Hearing System	Ear, Nose, Throat	Class 2	874.3340	2019-09-16
MHE	Implant, Auditory Brainstem	Unknown	Class 3	N/A	2005-08-10
MCM	Implant, Cochlear	Unknown	Class 3	N/A	2005-08-10
MCM	Implant, Cochlear	Unknown	Class 3	N/A	2005-08-10
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2012-05-29
MHE	Implant, Auditory Brainstem	Unknown	Class 3	N/A	2005-08-10
MCM	Implant, Cochlear	Unknown	Class 3	N/A	2005-08-10
MCM	Implant, Cochlear	Unknown	Class 3	N/A	2005-08-10

Official Correspondent

No official correspondent registered.

US Agent Details

Laura Blair Business: Cochlear Americas Email: lblair@cochlear.com Phone: (800) 5235798

Related Public Records

Same Entity

COCHLEAR AMERICAS

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3002806740	COCHLEAR LTD.	LANE COVE New South Wales, AU
3013177549	Cochlear Malaysia Sdn Bhd	Kuala Lumpur Kuala Lumpur, MY
9616024	COCHLEAR BONE ANCHORED SOLUTIONS AB	Molnlycke Vastra Gotaland, SE
3009092818	Cochlear Ltd	Macquarie University New South Wales, AU
3014579188	Cochlear Americas Warehouse	Centennial, CO, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K143738	Intuit Medical Products, LLC	DSS Sinusplasty Balloon Catheter	2015-08-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2012	Cochlear Americas Inc.	3	Cochlear 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 auditory sensation via the electrical stimulation of the auditory nerve.
Z-0044-05	Advanced Bionics	3	Advanced Bionics implantable cochlear stimulator CLARION 1.2 Models AB-5100L AB-5100R AB-5100ML/R (For Export Only) AB-5100H AB-5100H-01A

Similar Registrations

Registration Number	Establishment Name	Location
3014990990	SONITUS MEDICAL (SHANGHAI) CO., LTD.	shanghai, CN
3034209804	YUH JAAN INDUSTRIAL CO., LTD.	Taichung City, TW
3013177549	Cochlear Malaysia Sdn Bhd	Kuala Lumpur Kuala Lumpur, MY
3005900820	COCHLEAR AMERICAS	Lone Tree, CO, US
3007367732	Oticon Medical AB	Askim Vastra Gotaland, SE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9613646. Last updated year: 2026. Please use registration number 9613646 when referencing this establishment in official correspondence.