PFO · Class II · 21 CFR 874.3340

FDA Product Code PFO: Active Implantable Bone Conduction Hearing System

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.

Leading manufacturers include Med-El Elektromedizinische Geraete GmbH, Cochlear Americas and Cochlear.

11
Total
10
Cleared
149d
Avg days
2018
Since
Declining activity - 1 submissions in the last 2 years vs 3 in the prior period
Review times improving: avg 127d recently vs 152d historically

FDA 510(k) Cleared Active Implantable Bone Conduction Hearing System Devices (Product Code PFO)

11 devices
1–11 of 11
Cleared Jul 10, 2024
Sentio Ti Implant Kit
K240614
Oticon Medical AB
Ear, Nose, Throat · 127d
Cleared Apr 18, 2024
Cochlear Osia System
K240155
Cochlear Americas
Ear, Nose, Throat · 90d
Cleared Aug 18, 2023
Cochlear™ Osia® System
K231204
Cochlear
Ear, Nose, Throat · 113d
Cleared Jul 27, 2022
Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit
K220922
Cochlear Americas
Ear, Nose, Throat · 118d
Cleared Oct 09, 2020
BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)
K201983
Med-El Elektromedizinische Geraete GmbH
Ear, Nose, Throat · 84d
Cleared Jul 29, 2020
BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote
K200504
Med-El Elektromedizinische Geraete GmbH
Ear, Nose, Throat · 149d
Cleared Nov 15, 2019
Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments
K191921
Cochlear Americas
Ear, Nose, Throat · 120d
Cleared Sep 18, 2019
BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)
K191457
Med-El Elektromedizinische Geraete GmbH
Ear, Nose, Throat · 110d
Cleared Jul 03, 2019
Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments
K190589
Cochlear Americas
Ear, Nose, Throat · 118d
Cleared Mar 07, 2019
Bonebridge
K183373
Med-El Elektromedizinische Geraete GmbH
Ear, Nose, Throat · 91d
Not Cleared Jul 20, 2018
Bonebridge
DEN170009
Med-El Elektromedizinische Geraete GmbH
Ear, Nose, Throat · 522d

About Product Code PFO - Regulatory Context

510(k) Submission Activity

11 total 510(k) submissions under product code PFO since 2018, with 10 receiving FDA clearance (average review time: 149 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 3 in the prior period.

FDA 510(k) Review Time - PFO Product Code

Recent submissions under PFO have taken an average of 127 days to reach a decision - down from 152 days historically, suggesting improved FDA processing for this classification.

PFO devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →