510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K231204Substantially Equivalent

Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App

Cochlear Ltd, Lone Tree CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K231204 is the FDA 510(k) clearance record for Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App, a class II device, cleared for Cochlear on under FDA product code PFO (Active Implantable Bone Conduction Hearing System). FDA's definition for product code PFO 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...". FDA records list 3 510(k) clearances for Cochlear, from to . As of , FDA records show no recalls naming K231204.

Clearance record

Decision date
Received
(113 days to decision)
Product code
PFO Active Implantable Bone Conduction Hearing System
Regulation
21 CFR 874.3340
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Cochlear 10350 Park Meadows Dr., Lone Tree CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PFO

Trailing 12 months
1 clearance under product code PFO in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PFO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260