Medical Device Manufacturer · US , Englewood , CO

Cochlear Americas - FDA 510(k) Cleared Devices

21 submissions · 21 cleared · Since 2008

Recent clearances: Cochlear Osia System, Instrument Case, Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit

21

Total

21

Cleared

0

Denied

FDA 510(k) Regulatory Record - Cochlear Americas Ear, Nose, Throat ✕

20 devices

1-12 of 20

Cleared Jul 10, 2026

Cochlear™ Osia® 3(I) Sound Processor

Ear, Nose, Throat · 114d

Cleared Apr 18, 2024

Cochlear Osia System

Ear, Nose, Throat · 90d

Cleared Jul 27, 2022

Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound...

Ear, Nose, Throat · 118d

Cleared Sep 29, 2021

Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha...

Ear, Nose, Throat · 83d

Cleared Feb 23, 2021

Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6,...

Ear, Nose, Throat · 214d

Cleared Nov 15, 2019

Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting...

Ear, Nose, Throat · 120d

Cleared CT Jul 03, 2019

Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia...

Ear, Nose, Throat · 118d

Cleared Dec 19, 2018

BA310 Abutment, BIA310 Implant/Abutment

Ear, Nose, Throat · 135d

Cleared Jun 07, 2017

Cochlear Baha SoundArc

Ear, Nose, Throat · 56d

Cleared May 20, 2016

Baha 5 Power Sound Processor

Ear, Nose, Throat · 29d

Cleared Mar 02, 2016

Baha 5 Super Power Sound Processor

Ear, Nose, Throat · 114d

Cleared Jul 22, 2015

Cordelle II Sound Processor

Ear, Nose, Throat · 121d