What is FDA product code PFO?

An active implantable bone conduction hearing system is a prescription device consisting of an implanted transducer, implanted electronics components, and an audio processor. The active implantable bone conduction hearing system is intended to compensate for conductive or mixed hearing losses by conveying amplified acoustic signals to the cochlea via mechanical vibrations on the skull bone.

Ear Nose & Throat › ProstheticActive Implantable Bone Conduction Hearing System

Osia® 2 Sound Processor Magnet Pack (Strength 2)

Name: Osia® 2 Sound Processor Magnet Pack (strength 2)
Brand: Osia® 2 Sound Processor Magnet Pack (strength 2)

Catalogue number Osia 2 System, listed by Cochlear Ltd., Australia, under Active Implantable Bone Conduction Hearing System. 3 manufacturers in China are registered for this product code.

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

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.

Chinese manufacturers registered for FDA product code PFO
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

Regulatory record for Osia® 2 Sound Processor Magnet Pack (strength 2)
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)	K191921
Record published	2020-09-05
Record revised	2024-05-03 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, manufacturing date
Storage	Special storage condition: Store at room temperature

Catalogue Numbers

Catalogue numbers for Osia® 2 Sound Processor Magnet Pack (strength 2)
Catalogue number	Size	Status
Osia 2 System		In distribution

Same Product Code

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
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.