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PFOClass II

Active Implantable Bone Conduction Hearing System

21 CFR 874.3340 / Ear, Nose, Throat
FDA source (opens on fda.gov)

PFO is the FDA product code for Active Implantable Bone Conduction Hearing System, a class II device type, regulated under 21 CFR 874.3340. FDA's definition for this code reads: "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...". As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PFO
Device name
Active Implantable Bone Conduction Hearing System
FDA definition
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.
Regulation
21 CFR 874.3340
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
12
Ingested recalls
0

Clearances, product code PFO

By decision year
12 clearances under product code PFO with a decision year between 2018 and 2026, 2019 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code PFO by decision year
YearClearances
20181
20194
20202
20221
20231
20242
20261

Applicants with the most clearances

Product code PFO
Applicants holding the most 510(k) clearances under product code PFO
ApplicantClearances
Cochlear Americas5
Med-el Elektromedizinische Geraete, GmbH5
Cochlear Ltd1
Oticon Medical AB1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order