# Cochlear Americas Warehouse (manufacturer, Centennial, CO): 1 new FDA device listing, incl. active implantable bone conduction hearing system

**Score:** 70/100

| Field | Value |
|---|---|
| Establishment | Cochlear Americas Warehouse |
| Owner / operator | Cochlear Americas |
| Role | Manufacturer |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device |
| Location | Centennial, CO, US |
| New listings | 1 |
| Devices | Active Implantable Bone Conduction Hearing System |
| Product codes | PFO |
| Device classes | Class II |
| Medical specialties | Ear, Nose, Throat |
| Brand names | Cochlear Osia 3(I) Sound Processor; Cochlear Osia 3 Charger; Cochlear Osia 3 Aqua+; Cochlear Osia 3 Sound Processor; Cochlear Osia Fitting Software 3; Cochlear Osia System; Osia Smart App |
| First new listing | 2026-07-13 |
| Latest new listing | 2026-07-13 |
| FDA registration number | 3014579188 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.