BCI Bone Conduction Implant Kit
Bone Conduction Implant Kit
3manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Shanghai (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| IN-Tech Electronics Ltd | Dongguan | Guangdong | Contract manufacturer | 2 |
Record
| Listed by | Med-El Elektromedizinische Geräte Gesellschaft m.b.H. |
|---|---|
| FDA product code | PFO |
| Device type | Active Implantable Bone Conduction Hearing System |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3340 |
| 510(k) | DEN170009 |
| Record published | 2019-04-17 |
| Record revised | 2025-10-10 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | expiry date, manufacturing date, serial number |
| Storage | Special storage condition: Store in a cool and dry place.; Handling environment temperature -4 to 140 °F; Handling environment temperature -20 to 60 °C |
| Distribution end date | 2025-03-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 52180 | Withdrawn | |
| 51032 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cochlear | Cochlear Ltd. | 7 |
| Sentio | Oticon Medical AB | 7 |
| Cochlear® Osia® 3 Sound Processor Magnet strength 4M | Cochlear Ltd. | 5 |
| Cochlear® Osia® 3(I) Sound Processor Magnet strength 4(I) | Cochlear Ltd. | 5 |
| Cochlear® Osia® Smart App | Cochlear Ltd. | 2 |
| Cochlear® Osia® Fitting Software 3 | Cochlear Ltd. | 2 |
| Symfit 8.0 Download | Med-El Elektromedizinische Geräte Gesellschaft m.b.H. | 2 |
| Cochlear® Osia® 3 Sound Processor Cover Mint | Cochlear Ltd. | 1 |
| Remote Control | Med-El Elektromedizinische Geräte Gesellschaft m.b.H. | 1 |
| Cochlear® Osia® 3(I) Sound Processor | Cochlear Ltd. | 1 |
| Samba 2 BB AP Unit, left | Med-El Elektromedizinische Geräte Gesellschaft m.b.H. | 1 |
| Samba 2 GO | Med-El Elektromedizinische Geräte Gesellschaft m.b.H. | 1 |
Showing 12 of 69. All products under Active Implantable Bone Conduction Hearing System
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.