Devices › Active implantable bone conduction hearing system
Device brand name · Cochlear osia system
Cochlear Osia OSI300 Implant: medical device reports filed with FDA
1,110 reports name it, 2024–2026. Manufacturer given most often on reports: Cochlear. Product code PFO.
- 1,110
- device reports naming the brand
- 0% of all MAUDE reports · about 445 a year
- 540
- reports, 12 months to August 2026
- 434 in the 12 months before
- 1.8%
- classified as malfunction
- 10.7% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
1,110 medical device reports received by FDA name the brand "Cochlear Osia OSI300 Implant" (cochlear osia system); the manufacturer given most often on reports is Cochlear; received from January 2024 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
540 reports arrived in the 12 months to August 2026, up 24% from 434 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 (98.2%) and malfunction (1.8%); across all active implantable bone conduction hearing system reports (product code PFO) death is recorded in 0% and malfunction in 10.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are expulsion (35.2%), insufficient device problem information (3.4%) and inadequacy of device shape and/or size (2.2%). The patient problems coded most often are tissue breakdown, medical device site infection and wound dehiscence. 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 3,471 reports carrying product code PFO. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Expulsion | 391 | 35.2% | 22.4% |
| Insufficient device problem information | 38 | 3.4% | 4.9% |
| Inadequacy of device shape and/or size | 24 | 2.2% | 1.5% |
| Unexpected therapeutic results | 19 | 1.7% | 1.9% |
| Loss of osseointegration | 13 | 1.2% | 1% |
| Failure to deliver shock/stimulation | 11 | 1% | 0.6% |
| Therapeutic or diagnostic output failure | 11 | 1% | 1.1% |
| Patient device interaction problem | 10 | 0.9% | 1.4% |
| Failure to read input signal | 9 | 0.8% | 0.6% |
| Signal artifact/noise | 8 | 0.7% | 0.9% |
| Loose or intermittent connection | 4 | 0.4% | 0.6% |
| Malposition of device | 4 | 0.4% | 0.4% |
| Output problem | 4 | 0.4% | 2.4% |
| Increased sensitivity | 2 | 0.2% | 0.1% |
| Intermittent shock/stimulation | 2 | 0.2% | 0.3% |
| Migrationthe device moved from where it was placed | 2 | 0.2% | 0.5% |
| No device output | 2 | 0.2% | 6.1% |
| Patient-device incompatibilitythe device did not suit the patient | 2 | 0.2% | 0.1% |
| Positioning failure | 2 | 0.2% | 0.2% |
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 |
|---|---|---|
| Tissue breakdown | 369 | 33.2% |
| Medical device site infectioninfection at the device site | 260 | 23.4% |
| Wound dehiscencea wound reopened | 149 | 13.4% |
| Painpain, site not specified | 99 | 8.9% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 92 | 8.3% |
| Fluid discharge | 81 | 7.3% |
| Impaired healingslow healing | 74 | 6.7% |
| Post operative wound infection | 64 | 5.8% |
| Swelling/ edema | 64 | 5.8% |
| Bacterial infectiona bacterial infection | 63 | 5.7% |
| Implant pain | 59 | 5.3% |
| Necrosisdeath of tissue | 53 | 4.8% |
| Skin erosion | 47 | 4.2% |
| Skin inflammation/ irritation | 41 | 3.7% |
| Head injurya head injury | 29 | 2.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Cochlear Osia OSI300 Implant | Product code PFO | All MAUDE reports |
|---|---|---|---|
| Reports | 1,110 | 3,471 | 26,136,888 |
| Share of that pool | — | 32% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 98.2% | 89.3% | 36.2% |
| Classified as malfunction | 1.8% | 10.7% | 62.3% |
| Filed by the manufacturer | 57.2% | 62.2% | 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."
Other brands with product code PFO
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Cochlear Osia OSI200 Implant | 1,824 | 247 | 0.1% |
| Bonebridge | 485 | 99 | 0% |
| Asku | 4,752 | 210 | 1.1% |
| Nucleus CI522 Cochlear Implant with Slim Straight Electrode | 1,584 | 179 | 0% |
| Nucleus CI422 Cochlear Implant with Slim Straight Electrode | 694 | 52 | 0% |
| Nucleus CI512 Cochlear Implant with Contour Advance Electrode | 2,605 | 232 | 0% |
| Nucleus CI532 Cochlear Implant with Slim Modiolar Electrode | 872 | 82 | 0% |
| Nucleus CI622 Cochlear Implant with Slim Straight Electrode | 2,398 | 510 | 0% |
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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Cochlear Osia OSI300 Implant reports
How many FDA reports name Cochlear Osia OSI300 Implant?
1,110 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 540 in the latest 12 months.
What kinds of events are reported?
injury (98.2%) and malfunction (1.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
expulsion (35.2%), insufficient device problem information (3.4%), inadequacy of device shape and/or size (2.2%), unexpected therapeutic results (1.7%) and loss of osseointegration (1.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (57.2%) and distributor reports (42.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Cochlear Osia OSI300 Implant 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.