Osia 2(I) Sound Processor Kit
The Osia 2(I) Sound Processor is the external component of a bone conduction hearing system. Worn off the ear, it captures and digitally processes sound, then transmits power and digital…
The Osia 2(I) Sound Processor is the external component of a bone conduction hearing system. Worn off the ear, it captures and digitally processes sound, then transmits power and digital information through a radiofrequency link to the compatible OSI300 implant.
The processor is held against the scalp by magnetic attraction to the implant. Its dedicated Imaging magnets support the OSI300 configuration. The implant converts the transmitted information into vibrations delivered through the skull bone to the cochlea.
Hearing Scope
The system is intended for patients aged 12 or older with conductive or mixed hearing loss and bone conduction thresholds averaging 55 dB HL or better, or single-sided deafness with opposite-ear air conduction thresholds averaging 20 dB HL or better. Averages use 0.5, 1, 2 and 3 kHz.
For bilateral conductive or mixed loss, the left-to-right bone conduction difference must be less than 10 dB averaged at those frequencies, or less than 15 dB at individual frequencies.
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 |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P1900830 | 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.