Data / Medical devices / Active Implantable Bone Conduction Hearing System
Active Implantable Bone Conduction Hearing System (PFO): 13 FDA-registered makers in 8 countries
13 establishments in 8 countries are registered with the FDA to make Active Implantable Bone Conduction Hearing System (product code PFO, Class 2, 21 CFR 874.3340). 7 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 12 510(k) clearances under this code, the latest on July 10, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PFO
- Device class
- 2
- Regulation
- 874.3340
- Medical specialty
- Ear, Nose, Throat
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| Sweden | 3 |
| China | 3 |
| Australia | 2 |
| United States | 1 |
| Malaysia | 1 |
| Austria | 1 |
| Poland | 1 |
| France | 1 |
Makers of Active Implantable Bone Conduction Hearing System
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Cochlear Bone Anchored Solutions AB | Molnlycke Vastra Gotaland, Sweden | Manufacturer, Specification developer | 5 | July 10, 2026 | 0 | 0 | 0 | api.fda.gov |
| Cochlear Americas Warehouse | Centennial, CO, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 5 | July 10, 2026 | 0 | 0 | 0 | api.fda.gov |
| Cochlear Ltd | Macquarie University New South Wales, Australia | Complaint file establishment, Manufacturer, Repackager or relabeler | 5 | July 10, 2026 | 0 | 0 | 0 | api.fda.gov |
| Cochlear Malaysia Sdn Bhd | Kuala Lumpur, Malaysia | Complaint file establishment, Manufacturer | 5 | July 10, 2026 | 0 | 0 | 0 | api.fda.gov |
| Cochlear Limited - Brisbane | Newstead Queensland, Australia | Specification developer | 1 | July 3, 2019 | 0 | 0 | 0 | api.fda.gov |
| Med-El Elektromedizinische Geraete, GMBH | INNSBRUCK Tirol, Austria | Manufacturer | 1 | July 20, 2018 | 0 | 0 | 0 | api.fda.gov |
| Oticon Medical AB | Askim Vastra Gotaland, Sweden | Complaint file establishment, Manufacturer, Specification developer | 1 | July 10, 2024 | 0 | 0 | 0 | api.fda.gov |
| Amb Industri AB | Broakulla Kalmar, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Demant Operations Poland Sp. z o.o. | Mierzyn Zachodniopomorskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| In-Tech Electronics Ltd | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ITSA Medical | Vallauris Alpes-Maritimes, France | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Circuit (Shanghai) Ltd. | Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mehow Innovative (huizhou) Ltd. | Huizhou Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 10, 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.