Osia 2(I) SP Magnet Strength 1(I)
The Osia 2(I) SP Magnet is a dedicated imaging magnet accessory for the Osia 2(I) Sound Processor. The processor is designed for compatibility with the OSI300 implant in the Cochlear Osia…
The Osia 2(I) SP Magnet is a dedicated imaging magnet accessory for the Osia 2(I) Sound Processor. The processor is designed for compatibility with the OSI300 implant in the Cochlear Osia System.
Dedicated imaging magnets, designated as (I) magnets, and a new tool for these magnets are included in the updated system. This listed strength 1(I) item belongs to the sound processor accessory configuration.
System Context
The Osia System uses bone conduction to transmit sound to the cochlea. The magnet is an accessory within the updated processor and implant arrangement; sound processing and hearing functions belong to the assembled system.
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 | Cochlear Ltd., Australia |
|---|---|
| FDA product code | PFO |
| Device type | Active Implantable Bone Conduction Hearing System |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3340 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K231204 |
| Record published | 2023-09-15 |
| Record revised | 2024-07-22 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P1900472 | In distribution |
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 |
| BCI Bone Conduction Implant Kit | 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 |
Showing 12 of 69. All products under Active Implantable Bone Conduction Hearing System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231204 | 2023-08-18 |
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.