Data / Medical devices / Malaysia / Cochlear Malaysia Sdn Bhd
Cochlear Malaysia Sdn Bhd: FDA-registered device maker in Kuala Lumpur, Malaysia, 19 510(k) clearances and 3 PMA approvals
Cochlear Malaysia Sdn Bhd is registered with the FDA (registration 3013177549) in Kuala Lumpur, Malaysia. It lists 7 device types. The FDA files 19 510(k) clearances and 3 PMA approvals under its listings, the newest dated July 10, 2026. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3013177549
- Address
- Unit UG-1, Upper Ground Floor, Vertical Podium, The Vertical, Avenue 3 Bangsar South, No 8 Jalan Kerinchi, Kuala Lumpur, Malaysia, 59200
- Owner or operator
- COCHLEAR AMERICAS (9076254)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer
- First device listed
- August 10, 2005
- Registered through
- 2027
- Brand names listed
- BAHA IMPLANT SYSTEM, Ba400 14mm Abutment, Baha 5, Baha 5 Power, Baha 5 SuperPower Sound Processor, Baha 6 Max Sound Processor, Baha 7 Sound Processor and Accessories, Baha Attract and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Active Implantable Bone Conduction Hearing System | PFO | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification | PGQ | 3 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Hearing Aid, Bone Conduction | LXB | 2 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Hearing Aid, Bone Conduction, Implanted | MAH | 2 | Complaint file establishment, Exporter to the US | accessdata.fda.gov |
| Implant, Auditory Brainstem | MHE | 3 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Implant, Cochlear | MCM | 3 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Complaint file establishment | 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 |
| May 29, 2025 | K250215 | Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand | LXB | Substantially Equivalent | Cochlear | accessdata.fda.gov |
| August 24, 2023 | K231604 | Instrument Case | KCT | 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 |
| March 21, 2023 | K223672 | Instrument Case P1340904 | KCT | 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 |
| September 29, 2021 | K212136 | Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App | LXB | Substantially Equivalent | Cochlear Americas | accessdata.fda.gov |
| February 23, 2021 | K202048 | Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App | LXB | 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 |
| May 20, 2016 | K161123 | Baha 5 Power Sound Processor | LXB | 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 |
| July 15, 2015 | K150555 | BA400 14mm Abutment | MAH | Substantially Equivalent | Cochlear Americas | accessdata.fda.gov |
| March 25, 2015 | K142907 | Baha 5 Sound Processor | LXB | Substantially Equivalent | Cochlear Americas | accessdata.fda.gov |
| November 7, 2013 | K131240 | COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT | LXB | Substantially Equivalent | Cochlear Americas | accessdata.fda.gov |
| October 12, 2012 | K121317 | COCHLEAR BAHA IMPLANT SYSTEM | MAH | Substantially Equivalent | Cochlear Americas | accessdata.fda.gov |
| July 13, 2010 | K100360 | BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT | LXB | Substantially Equivalent | Cochlear Americas | accessdata.fda.gov |
| October 17, 2000 | K002913 | HEADBAND FOR BAHA | LXB | Substantially Equivalent | Entific Medical Systems, Inc. | accessdata.fda.gov |
| August 9, 1996 | K955713 | NOBELPHARMA BONE ANCHORED HEARING AID | LXB | Substantially Equivalent | Nobelpharma USA, Inc. | 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 |
Compare with other makers
- All makers of Hearing Aid, Bone Conduction
- All makers of Hearing Aid, Bone Conduction, Implanted
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Active Implantable Bone Conduction Hearing System
- All makers of Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
- All makers of Implant, Cochlear
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.