Hearing aid, bone conduction, implanted: medical device reports filed with FDA

6,708 reports carry this product code, 1996–2026; 20 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.

6,708
reports with this product code: 0% of all MAUDE reports; 489
reports, 12 months to August 2026: 603 in the 12 months before; 0.5%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code MAH is FDA's classification for "Hearing aid, bone conduction, implanted" (ear, Nose, Throat panel), a class 2 device. 6,708 medical device reports carry this product code, 0% of the MAUDE database, from October 1996 to August 2026.

489 reports arrived in the 12 months to August 2026, down 19% from 603 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%), other (1.4%) and malfunction (0.5%). 20 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
Asku	947	210	1.1%	47.1%
BIA400 Implant 4mm w Abutment 10mm	815	68	0%	0%
Ponto	799	42	0%	0%
BIA400 Implant 4mm w Abutment 12mm	652	35	0%	0.1%
BIA400 Implant 4mm w Abutment 8mm	489	33	0%	0%
BA400 Abutment 10mm	412	18	0%	0%
BA400 Abutment 12mm	313	21	0%	0%
Ba400 Abutment 8mm	301	7	0%	0.3%
BIA400 Implant 4mm w Abutment 14mm	200	25	0%	0.5%
Flange Fixture And Abutment	97	0	0%	0.3%
Vibrant Soundbridge	33	82	0%	38.7%
BIM400 Implant Magnet	18	153	0%	0.6%
Flange Fixture St 4mm W Baha Abutment	15	9	0%	0%
Bi300 Implant 3mm	13	19	0%	0%
BI300 Implant 4 mm	12	28	0%	0.6%
Bonebridge	2	99	0%	64.9%
Astral 100 - AMER	1	92	1%	98.2%
Nucleus Ci24re Ca Cochlear Implant With Contour Advance Electrode	1	15	0%	12.5%
Nucleus CI632 Profile Plus with Slim Modiolar Electrode	1	461	0%	3.5%
Nucleus Freedom Implant with Contour Advance Electrode	1	189	0.2%	11.8%

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 Bone Anchored Solutions	5,759	85.9%
Oticon Medical	930	13.9%
Cochlear	17	0.3%
Med-El Elektromedizinische Geraete	2	0%
Resmed	2	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 and report source

Event type

Death0%0

Injury96%6,441

Malfunction0.5%31

Other1.4%95

Not given2.1%141

Who filed

Manufacturer report72.4%4,856

Voluntary report0.1%9

User facility report0%0

Distributor report27.5%1,842

Not given0%1

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

Device problems coded

Device problem (FDA code)	Reports	Share
Patient device interaction problem	1,876	28%
Loss of osseointegration	915	13.6%
Failure to osseointegrate	559	8.3%
Insufficient device problem information	132	2%
Loosening of implant not related to bone-ingrowth	115	1.7%
Osseointegration problem	54	0.8%
Detachment of device or device componentpart of the device came off	33	0.5%
Inadequacy of device shape and/or size	32	0.5%
Explanted	22	0.3%
Therapeutic or diagnostic output failure	20	0.3%
Extrusion	19	0.3%
Patient-device incompatibilitythe device did not suit the patient	12	0.2%
Biocompatibility	8	0.1%
Unexpected therapeutic results	8	0.1%
Device remains implanted	7	0.1%
Device issuea problem with the device	6	0.1%
Expulsion	6	0.1%
Replace	6	0.1%
Device appears to trigger rejection	5	0.1%
Output problem	5	0.1%

Questions about hearing aid, bone conduction, implanted reports

What is product code MAH?

FDA's classification code for "Hearing aid, bone conduction, implanted", 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?

6,708 reports through August 2026, 489 of them in the latest 12 months.

Which brands appear most often?

Asku (947), BIA400 Implant 4mm w Abutment 10mm (815), Ponto (799), BIA400 Implant 4mm w Abutment 12mm (652) and BIA400 Implant 4mm w Abutment 8mm (489). 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.