Devices › Hearing aid, bone conduction
Device brand name · Cochlear baha connect system
BI300 Implant 4 mm: medical device reports filed with FDA
314 reports name it, 2017–2026. Manufacturer given most often on reports: Cochlear Bone Anchored Solutions. Product code LXB.
- 314
- device reports naming the brand
- 0% of all MAUDE reports · about 33 a year
- 28
- reports, 12 months to August 2026
- 22 in the 12 months before
- 0.6%
- classified as malfunction
- 0.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 314 reports that name the brand "BI300 Implant 4 mm" (cochlear baha connect system), received between January 2017 and August 2026; the manufacturer given most often on reports is Cochlear Bone Anchored Solutions. Spellings of one product vary from report to report.
28 reports arrived in the 12 months to August 2026, up 27% from 22 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 (99.4%) and malfunction (0.6%); across all hearing aid, bone conduction reports (product code LXB) death is recorded in 0% and malfunction in 0.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are loss of osseointegration (16.2%), patient device interaction problem (15.3%) and insufficient device problem information (3.2%). The patient problems coded most often are skin infection, pain and inadequate osseointegration. 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 7,135 reports carrying product code LXB. 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 |
|---|---|---|---|
| Loss of osseointegration | 51 | 16.2% | 17% |
| Patient device interaction problem | 48 | 15.3% | 8.7% |
| Insufficient device problem information | 10 | 3.2% | 3.7% |
| Expulsion | 4 | 1.3% | 1% |
| Failure to osseointegrate | 3 | 1% | 3.6% |
| Biocompatibility | 2 | 0.6% | 0.3% |
| Device dislodged or dislocated | 2 | 0.6% | 0.6% |
| Inadequacy of device shape and/or size | 2 | 0.6% | 0.4% |
| Loosening of implant not related to bone-ingrowth | 2 | 0.6% | 0.2% |
| Therapeutic or diagnostic output failure | 2 | 0.6% | 0.4% |
| Unexpected therapeutic results | 2 | 0.6% | 0.2% |
| Device issuea problem with the device | 1 | 0.3% | 0% |
| Migration or expulsion of device | 1 | 0.3% | 0.1% |
| Osseointegration problem | 1 | 0.3% | 0.1% |
| Patient-device incompatibilitythe device did not suit the patient | 1 | 0.3% | 0.4% |
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 |
|---|---|---|
| Skin infection | 31 | 9.9% |
| Painpain, site not specified | 29 | 9.2% |
| Inadequate osseointegration | 22 | 7% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 20 | 6.4% |
| Bacterial infectiona bacterial infection | 13 | 4.1% |
| Hearing impairment | 9 | 2.9% |
| Discomfortdiscomfort | 8 | 2.5% |
| Impaired healingslow healing | 8 | 2.5% |
| Tissue breakdown | 8 | 2.5% |
| Skin inflammation/ irritation | 7 | 2.2% |
| Head injurya head injury | 6 | 1.9% |
| Headachehead pain | 5 | 1.6% |
| Host-tissue reaction | 5 | 1.6% |
| Purulent discharge | 5 | 1.6% |
| Foreign body reaction | 4 | 1.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | BI300 Implant 4 mm | Product code LXB | All MAUDE reports |
|---|---|---|---|
| Reports | 314 | 7,135 | 26,136,888 |
| Share of that pool | — | 4.4% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 99.4% | 98.3% | 36.2% |
| Classified as malfunction | 0.6% | 0.6% | 62.3% |
| Filed by the manufacturer | 70.1% | 83.7% | 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 LXB
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Flange Fixture And Abutment | 2,920 | 0 | 0% |
| BIM400 Implant Magnet | 1,155 | 153 | 0% |
| Asku | 4,752 | 210 | 1.1% |
| Baha Flange And Abutment | 188 | 0 | 0% |
| Flange Fixture St 4mm W Baha Abutment | 197 | 9 | 0% |
| Bi300 Implant 3mm | 181 | 19 | 0% |
| BIA400 Implant 4mm w Abutment 12mm | 673 | 35 | 0% |
| BIA400 Implant 4mm w Abutment 10mm | 833 | 68 | 0% |
| BIA400 Implant 4mm w Abutment 8mm | 502 | 33 | 0% |
| Ba400 Abutment 8mm | 312 | 7 | 0% |
| BA400 Abutment 12mm | 321 | 21 | 0% |
| BA400 Abutment 10mm | 419 | 18 | 0% |
| BIA400 Implant 4mm w Abutment 14mm | 205 | 25 | 0% |
| Nucleus 24 Channel Cochlear Implant System | 12,137 | 0 | 0.1% |
| Cochlear Osia OSI200 Implant | 1,824 | 247 | 0.1% |
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 BI300 Implant 4 mm reports
How many FDA reports name BI300 Implant 4 mm?
314 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 28 in the latest 12 months.
What kinds of events are reported?
injury (99.4%) and malfunction (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
loss of osseointegration (16.2%), patient device interaction problem (15.3%), insufficient device problem information (3.2%), expulsion (1.3%) and failure to osseointegrate (1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (70.1%) and distributor reports (29.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that BI300 Implant 4 mm 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.