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FDA product code MCM · class 3 · Unknown
Implant, cochlear: medical device reports filed with FDA
75,481 reports carry this product code, 1993–2026; 30 brands with a page.
- 75,481
- reports with this product code
- 0.3% of all MAUDE reports
- 5,436
- reports, 12 months to August 2026
- 5,392 in the 12 months before
- 43.1%
- classified as malfunction
- 62.3% across all reports
- 0.1%
- classified as death, as reported
- 0.9% across all reports
Product code MCM is FDA's classification for "Implant, cochlear" (unknown panel), a class 3 device. 75,481 medical device reports carry this product code, 0.3% of the MAUDE database, from October 1993 to August 2026.
5,436 reports arrived in the 12 months to August 2026, close to the 5,392 of the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (56.2%), malfunction (43.1%) and other (0.5%). 30 brand names with a page on this site carry this code; the brands table is ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Brands with this product code
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Manufacturers named
| Manufacturer (as written on reports) | Reports | Share |
|---|---|---|
| Cochlear | 34,553 | 45.8% |
| Advanced Bionics | 23,336 | 30.9% |
| Med-El Elektromedizinische Geraete | 16,607 | 22% |
| Cochlear Bone Anchored Solutions | 73 | 0.1% |
| Alcon Laboratories /Huntington | 2 | 0% |
| Medtronic Xomed | 1 | 0% |
| Resmed | 1 | 0% |
| St Jude Medical - Neuromodulation | 1 | 0% |
Reports by month, five years
FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
Event type and report source
Event type
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Mechanical problema mechanical problem | 7,281 | 9.6% |
| Device operates differently than expectedthe device behaved unexpectedly | 6,112 | 8.1% |
| Impedance problem | 5,742 | 7.6% |
| Output problem | 5,243 | 6.9% |
| Insufficient device problem information | 4,533 | 6% |
| Explanted | 4,198 | 5.6% |
| Device remains implanted | 3,851 | 5.1% |
| No device output | 3,796 | 5% |
| Expulsion | 2,749 | 3.6% |
| Migrationthe device moved from where it was placed | 2,594 | 3.4% |
| Device issuea problem with the device | 2,361 | 3.1% |
| Replace | 2,094 | 2.8% |
| Migration or expulsion of device | 1,771 | 2.3% |
| Circuit failure | 1,689 | 2.2% |
| Therapeutic or diagnostic output failure | 1,668 | 2.2% |
| High impedance | 1,187 | 1.6% |
| Device stops intermittentlythe device stopped now and then | 941 | 1.2% |
| Device dislodged or dislocated | 898 | 1.2% |
| Repair | 876 | 1.2% |
| Extrusion | 800 | 1.1% |
Questions about implant, cochlear reports
What is product code MCM?
FDA's classification code for "Implant, cochlear", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.
How many reports carry this code?
75,481 reports through August 2026, 5,436 of them in the latest 12 months.
Which brands appear most often?
Nucleus 24 Channel Cochlear Implant System (12,121), Med-El Maestro Cochlear Implant System (7,389), MED-EL Combi 40+ Cochlear Implant System (6,133), HiRes Ultra Implant (5,384) and HiRes Ultra 3D Implant (4,177). Widely used products collect more reports because more people use them.
Can the brands table be used to rank the devices?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." Brands differ in how many are in use, how long they have been sold and how reports are collected.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.