FDA product code MCM: Implant, Cochlear

MCM is the FDA product code for implant, cochlear. It is a Class III device, reviewed by the Ear, Nose and Throat panel. Devices under MCM reach the market by PMA; FDA lists no cleared 510(k)s for it. 9 PMA applications cite this product code. FDA has posted 32 recalls for MCM devices, 6 initiated in the last five years.

Classification

Recalls for MCM devices

32 product recalls in 21 recall events; 6 initiated in the last five years and 6 still open. Most recent: 2026-04-30.

HCPCS codes with matching descriptors

Text match between the FDA device name and CMS descriptors, not an official crosswalk:

• L8628 — Cochlear implant, external controller component, replacement
• L8616 — Microphone for use with cochlear implant device, replacement
• L8627 — Cochlear implant, external speech processor, component, replacement
• L8615 — Headset/headpiece for use with cochlear implant device, replacement
• L8617 — Transmitting coil for use with cochlear implant device, replacement

Frequently asked questions

What is FDA product code MCM?

MCM is the FDA product code for implant, cochlear. It is a Class III device, reviewed by the Ear, Nose and Throat panel.

What device class is MCM?

Class III. Typical premarket route: PMA.

Have MCM devices been recalled?

Yes: 32 product recalls across 21 recall events; the most recent began 2026-04-30.

Next steps

• Run an FDA pathway report with predicate devices for product code MCM
• Run a recall and safety report across every MCM manufacturer
• Watch product code MCM for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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