Active implantable bone conduction hearing system: medical device reports filed with FDA

3,471 reports carry this product code, 2018–2026; 9 brands with a page.

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.

3,471
reports with this product code: 0% of all MAUDE reports; 969
reports, 12 months to August 2026: 928 in the 12 months before; 10.7%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code PFO is FDA's classification for "Active implantable bone conduction hearing system" (ear, Nose, Throat panel), a class 2 device. 3,471 medical device reports carry this product code, 0% of the MAUDE database, from October 2018 to August 2026.

969 reports arrived in the 12 months to August 2026, close to the 928 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 (89.3%) and malfunction (10.7%). 9 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

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Cochlear Osia OSI200 Implant	1,736	247	0.1%	3.8%
Cochlear Osia OSI300 Implant	1,089	540	0%	1.8%
Bonebridge	385	99	0%	64.9%
Asku	62	210	1.1%	47.1%
Nucleus CI522 Cochlear Implant with Slim Straight Electrode	2	179	0%	13.1%
Nucleus CI422 Cochlear Implant with Slim Straight Electrode	1	52	0%	13.4%
Nucleus CI512 Cochlear Implant with Contour Advance Electrode	1	232	0%	25.6%
Nucleus CI532 Cochlear Implant with Slim Modiolar Electrode	1	82	0%	12.6%
Nucleus CI622 Cochlear Implant with Slim Straight Electrode	1	510	0%	4.9%

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	3,015	86.9%
Med-El Elektromedizinische Geraete	405	11.7%
Cochlear Bone Anchored Solutions	58	1.7%
Oticon Medical	36	1%

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

Death0%1

Injury89.3%3,099

Malfunction10.7%370

Other0%1

Not given0%0

Who filed

Manufacturer report62.2%2,159

Voluntary report0.2%6

User facility report0%0

Distributor report37.6%1,304

Not given0.1%2

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Expulsion	779	22.4%
No device output	213	6.1%
Insufficient device problem information	171	4.9%
Device dislodged or dislocated	93	2.7%
Output problem	82	2.4%
Device appears to trigger rejection	81	2.3%
Unexpected therapeutic results	65	1.9%
Inadequacy of device shape and/or size	51	1.5%
Patient device interaction problem	47	1.4%
Therapeutic or diagnostic output failure	38	1.1%
Loss of osseointegration	33	1%
Signal artifact/noise	31	0.9%
Failure to deliver shock/stimulation	22	0.6%
Failure to read input signal	22	0.6%
Loose or intermittent connection	21	0.6%
Noise, audible	17	0.5%
Improper or incorrect procedure or method	16	0.5%
Migrationthe device moved from where it was placed	16	0.5%
Malposition of device	14	0.4%
Device handling problem	13	0.4%

Questions about active implantable bone conduction hearing system reports

What is product code PFO?

FDA's classification code for "Active implantable bone conduction hearing system", class 2, reviewed by the ear, Nose, Throat panel. Every device report carries the product code of the device involved.

How many reports carry this code?

3,471 reports through August 2026, 969 of them in the latest 12 months.

Which brands appear most often?

Cochlear Osia OSI200 Implant (1,736), Cochlear Osia OSI300 Implant (1,089), Bonebridge (385), Asku (62) and Nucleus CI522 Cochlear Implant with Slim Straight Electrode (2). 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.