Device manufacturer, as written on reports

Cochlear Bone Anchored Solutions: medical device reports filed with FDA

13,023 reports name it as the manufacturer of the device involved, 2008–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

13,023
reports naming it as manufacturer: 0.1% of all MAUDE reports; 734
reports, 12 months to August 2026: 807 in the 12 months before; 0.3%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

13,023 medical device reports received by FDA give Cochlear Bone Anchored Solutions as the manufacturer of the device involved, 0.1% of the MAUDE database, from February 2008 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

734 reports arrived in the 12 months to August 2026, close to the 807 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 (99.6%) and malfunction (0.3%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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 named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Flange Fixture And Abutment	Hearing aid, bone conduction	2,890	0	0%
Asku	Pulse-generator, pacemaker, external	1,542	210	1.1%
BIM400 Implant Magnet	Hearing aid, bone conduction	1,150	153	0%
Ni	Set, administration, for peritoneal dialysis, disposable	1,023	1,587	1.8%
BIA400 Implant 4mm w Abutment 10mm	Hearing aid, bone conduction, implanted	830	68	0%
BIA400 Implant 4mm w Abutment 12mm	Hearing aid, bone conduction, implanted	670	35	0%
BIA400 Implant 4mm w Abutment 8mm	Hearing aid, bone conduction, implanted	494	33	0%
BA400 Abutment 10mm	Hearing aid, bone conduction, implanted	417	18	0%
BA400 Abutment 12mm	Hearing aid, bone conduction, implanted	317	21	0%
BI300 Implant 4 mm	Hearing aid, bone conduction	314	28	0%
Ba400 Abutment 8mm	Hearing aid, bone conduction, implanted	312	7	0%
BIA400 Implant 4mm w Abutment 14mm	Hearing aid, bone conduction, implanted	204	25	0%
Flange Fixture St 4mm W Baha Abutment	Hearing aid, bone conduction	196	9	0%
Baha Flange And Abutment	Hearing aid, bone conduction	188	0	0%
Bi300 Implant 3mm	Hearing aid, bone conduction	181	19	0%
Cochlear Osia OSI200 Implant	Active implantable bone conduction hearing system	45	247	0.1%
Nucleus CI632 Profile Plus with Slim Modiolar Electrode	Implant, cochlear	9	461	0%
Nucleus CI512 Cochlear Implant with Contour Advance Electrode	Implant, cochlear	7	232	0%
Nucleus Ci24re Ca Cochlear Implant With Contour Advance Electrode	Implant, cochlear	6	15	0%
Nucleus CI622 Cochlear Implant with Slim Straight Electrode	Implant, cochlear	5	510	0%
Nucleus Freedom Implant with Contour Advance Electrode	Implant, cochlear	5	189	0.2%

Brands with a page on this site, 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."

Device types

Product code	Device type	Reports	Share
LXB	Hearing aid, bone conduction	7,008	53.8%
MAH	Hearing aid, bone conduction, implanted	5,759	44.2%
MCM	Implant, cochlear	73	0.6%
PFO	Active implantable bone conduction hearing system	58	0.4%
GEY	Motor, surgical instrument, ac-powered	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

Death0%2

Injury99.6%12,966

Malfunction0.3%40

Other0%0

Not given0.1%15

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Cochlear Bone Anchored Solutions reports

How many FDA device reports name Cochlear Bone Anchored Solutions as manufacturer?

13,023 reports through August 2026, 734 of them in the latest 12 months.

Which of its brands appear most often?

Flange Fixture And Abutment (2,890), Asku (1,542), BIM400 Implant Magnet (1,150), Ni (1,023) and BIA400 Implant 4mm w Abutment 10mm (830).

Which device types does it report on?

hearing aid, bone conduction (53.8%), hearing aid, bone conduction, implanted (44.2%), implant, cochlear (0.6%) and active implantable bone conduction hearing system (0.4%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number 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."

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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.