FDA Device Intelligence
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Implant, Cochlear

FDA product code MCM · Class 3 · Unknown

4,024
Registered devices
75,022
Adverse events
32
Recalls
0
510(k) clearances

Devices with this code

SONNET 3 EAS Kit (Me1723) BAT FTE White — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.Naida™ CI M30 — Advanced Bionics CorporationNucleus — COCHLEAR LIMITEDNucleus — COCHLEAR LIMITEDNeptune™ Cable for AquaMic — Advanced Bionics, LLCNucleus — COCHLEAR LIMITEDNeptune™ Cable for UHP — Advanced Bionics, LLCNaida CI Q90 — Advanced Bionics, LLCNaida™ CI M90 Sound Processor — Advanced Bionics, LLCCochlear™ Nucleus® 8 Slimline™ Coil (5(I)) — COCHLEAR LIMITEDNucleus — COCHLEAR LIMITEDPowerCel™ 110 Mini — Advanced Bionics, LLCNucleus — COCHLEAR LIMITEDNeptune™ Cable for UHP — Advanced Bionics, LLCCochlear™ Tamper Resistant Earhook — COCHLEAR LIMITEDDL-Coil Kit SYNCHRONY ebony — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.HiRes 90K™ Replacement Magnet — Advanced Bionics, LLCNucleus — COCHLEAR LIMITEDCochlear™ Headband — COCHLEAR LIMITEDCP1000 Magnet (5 M, Black) - Bulk Pack — COCHLEAR LIMITEDUHP 3D Color Cap — Advanced Bionics AGUHP Cable BTE — Advanced Bionics, LLCCochlear™ Magnet — COCHLEAR LIMITEDPowerCel™ 110 Mini — Advanced Bionics, LLC

Recent recalls

DateFirmReason
2026-04-30Advanced Bionics, LLCDue to incorrect shelf-life expiration date.
2026-03-23Advanced Bionics, LLCThe non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to replace the but
2025-11-27Advanced Bionics, LLCBehind-the-ear sound processer packaging label is different then included product.
2025-03-05Advanced Bionics, LLCDue to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.
2024-04-18MED-EL Elektromedizinische Gereate, GmbhA small number of devices may have a higher probability of a crack within the internal electronics substrate which could result in a non-functional device.
2024-04-08MEDLINE INDUSTRIES, LP - NorthfieldMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee
2020-09-26Advanced Bionics, LLCMislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
2020-09-26Advanced Bionics, LLCMislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
2020-02-17Advanced Bionics, LLChearing performance degradation due to body-fluid entering the device.
2020-02-17Advanced Bionics, LLChearing performance degradation due to body-fluid entering the device.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.