Device brand name · Nucleus hybrid cochlear implant system
Nucleus Hybrid L24: medical device reports filed with FDA
216 reports name it, 2016–2026. Manufacturer given most often on reports: Cochlear.
- 216
- device reports naming the brand
- 0% of all MAUDE reports · about 23 a year
- 22
- reports, 12 months to August 2026
- 12 in the 12 months before
- 3.7%
- classified as malfunction
- 62.3% across all reports
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
216 medical device reports received by FDA name the brand "Nucleus Hybrid L24" (nucleus hybrid cochlear implant system); the manufacturer given most often on reports is Cochlear; received from December 2016 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
22 reports arrived in the 12 months to August 2026, up 83% from 12 in 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 (96.3%) and malfunction (3.7%). Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are therapeutic or diagnostic output failure (10.2%), insufficient device problem information (7.9%) and output problem (5.6%). The patient problems coded most often are appropriate clinical signs, symptoms and conditions term/code not available, hearing impairment and pain. 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."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Therapeutic or diagnostic output failure | 22 | 10.2% |
| Insufficient device problem information | 17 | 7.9% |
| Output problem | 12 | 5.6% |
| Device dislodged or dislocated | 5 | 2.3% |
| Expulsion | 5 | 2.3% |
| Migrationthe device moved from where it was placed | 4 | 1.9% |
| Failure to deliver shock/stimulation | 3 | 1.4% |
| Circuit failure | 2 | 0.9% |
| Impedance problem | 2 | 0.9% |
| Migration or expulsion of device | 2 | 0.9% |
| Noise, audible | 2 | 0.9% |
| Unexpected therapeutic results | 2 | 0.9% |
| Application program problem | 1 | 0.5% |
| Extrusion | 1 | 0.5% |
| Low impedance | 1 | 0.5% |
| Patient-device incompatibilitythe device did not suit the patient | 1 | 0.5% |
| Positioning failure | 1 | 0.5% |
| Positioning problem | 1 | 0.5% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Appropriate clinical signs, symptoms and conditions term/code not available | 72 | 33.3% |
| Hearing impairment | 58 | 26.9% |
| Painpain, site not specified | 9 | 4.2% |
| Head injurya head injury | 7 | 3.2% |
| Bacterial infectiona bacterial infection | 4 | 1.9% |
| Tissue breakdown | 4 | 1.9% |
| Undesired nerve stimulation | 3 | 1.4% |
| Discomfortdiscomfort | 2 | 0.9% |
| Tinnitusringing in the ears | 2 | 0.9% |
| Dizzinesslight-headedness or unsteadiness | 1 | 0.5% |
| Headachehead pain | 1 | 0.5% |
| Implant pain | 1 | 0.5% |
| Medical device site infectioninfection at the device site | 1 | 0.5% |
| Necrosisdeath of tissue | 1 | 0.5% |
| Necrosis of flap tissue | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Nucleus Hybrid L24 | All MAUDE reports |
|---|---|---|
| Reports | 216 | 26,136,888 |
| Share of that pool | — | 0% |
| Classified as death, per 1,000 reports | 0 | 9 |
| Classified as injury | 96.3% | 36.2% |
| Classified as malfunction | 3.7% | 62.3% |
| Filed by the manufacturer | 65.3% | 94.9% |
Shares are of reports, not of devices in use. 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."
Questions about Nucleus Hybrid L24 reports
How many FDA reports name Nucleus Hybrid L24?
216 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 22 in the latest 12 months.
What kinds of events are reported?
injury (96.3%) and malfunction (3.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
therapeutic or diagnostic output failure (10.2%), insufficient device problem information (7.9%), output problem (5.6%), device dislodged or dislocated (2.3%) and expulsion (2.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (65.3%) and distributor reports (34.7%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Nucleus Hybrid L24 was at fault?
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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.