Reported Reactions

Devices › Implant, hearing, active, middle ear, partially implanted

Device brand name · Middle ear implant

Vibrant Soundbridge: medical device reports filed with FDA

1,265 reports name it, 2005–2026. Manufacturer given most often on reports: Med-El Elektromedizinische Geraete. Product code MPV.

1,265
device reports naming the brand
0% of all MAUDE reports · about 59 a year
82
reports, 12 months to August 2026
91 in the 12 months before
38.7%
classified as malfunction
38.6% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

1,265 medical device reports received by FDA name the brand "Vibrant Soundbridge" (middle ear implant); the manufacturer given most often on reports is Med-El Elektromedizinische Geraete; received from February 2005 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

82 reports arrived in the 12 months to August 2026, down 10% from 91 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 (59.2%), malfunction (38.7%) and other (2%); across all implant, hearing, active, middle ear, partially implanted reports (product code MPV) death is recorded in 0% and malfunction in 38.6%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are device operates differently than expected (23.1%), no device output (17%) and insufficient device problem information (14%). The patient problems coded most often are failure of implant, hearing loss and hearing impairment. 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

0611Sep 2021: 0Oct 2021: 2Nov 2021: 2Dec 2021: 32022Jan 2022: 0Feb 2022: 2Mar 2022: 3Apr 2022: 2May 2022: 3Jun 2022: 1Jul 2022: 1Aug 2022: 1Sep 2022: 7Oct 2022: 4Nov 2022: 6Dec 2022: 02023Jan 2023: 6Feb 2023: 3Mar 2023: 7Apr 2023: 7May 2023: 8Jun 2023: 1Jul 2023: 5Aug 2023: 4Sep 2023: 6Oct 2023: 4Nov 2023: 6Dec 2023: 82024Jan 2024: 3Feb 2024: 11Mar 2024: 2Apr 2024: 4May 2024: 10Jun 2024: 3Jul 2024: 8Aug 2024: 8Sep 2024: 9Oct 2024: 5Nov 2024: 6Dec 2024: 112025Jan 2025: 7Feb 2025: 6Mar 2025: 9Apr 2025: 8May 2025: 10Jun 2025: 5Jul 2025: 8Aug 2025: 7Sep 2025: 10Oct 2025: 9Nov 2025: 5Dec 2025: 62026Jan 2026: 8Feb 2026: 6Mar 2026: 10Apr 2026: 4May 2026: 3Jun 2026: 7Jul 2026: 8Aug 2026: 6

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

0651292005: 1420052006: 222007: 182008: 3520082009: 632010: 572011: 8720112012: 852013: 1292014: 10520142015: 802016: 662017: 4220172018: 472019: 322020: 3720202021: 292022: 302023: 6520232024: 802025: 902026: 522026

Event type and report source

Event type, as classified on the report

Death0%0
Injury59.2%749
Malfunction38.7%490
Other2%25
Not given0.1%1

Who filed the report

Manufacturer report100%1,265
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 1,338 reports carrying product code MPV. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Device operates differently than expectedthe device behaved unexpectedly29223.1%22%
No device output21517%16.4%
Insufficient device problem information17714%13.9%
Output problem13010.3%14.2%
Migrationthe device moved from where it was placed12710%9.6%
Device appears to trigger rejection745.8%7.1%
Explanted584.6%3.1%
Replace352.8%2.2%
Extrusion292.3%2.2%
Improper or incorrect procedure or method241.9%1.8%
Breakthe device broke161.3%1.3%
Device dislodged or dislocated131%1%
Device issuea problem with the device131%0.5%
Device inoperablethe device could not be used120.9%0.9%
Device remains implanted120.9%0.5%
Device stops intermittentlythe device stopped now and then120.9%0.9%
Malposition of device110.9%0.9%
Cut in material100.8%0.7%
Migration or expulsion of device90.7%0.7%
Positioning problem90.7%0.7%

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)ReportsShare
Failure of implant44735.3%
Hearing loss20416.1%
Hearing impairment18614.7%
Therapeutic response, decreased1028.1%
Skin tears383%
Surgical procedure322.5%
Tissue damage292.3%
Tissue breakdown272.1%
Surgical procedure, repeated262.1%
Deafnesshearing loss252%
Painpain, site not specified181.4%
Bacterial infectiona bacterial infection110.9%
Therapy/non-surgical treatment, additional110.9%
Headachehead pain80.6%
Falla fall70.6%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureVibrant SoundbridgeProduct code MPVAll MAUDE reports
Reports1,2651,33826,136,888
Share of that pool—94.5%0%
Classified as death, per 1,000 reports009
Classified as injury59.2%59.5%36.2%
Classified as malfunction38.7%38.6%62.3%
Filed by the manufacturer100%99.9%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 MPV

BrandReportsLatest 12 monthsClassified as death
Bonebridge485990%
MED-EL Combi 40+ Cochlear Implant System6,14900%
Med-El Maestro Cochlear Implant System7,39100%

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 Vibrant Soundbridge reports

How many FDA reports name Vibrant Soundbridge?

1,265 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 82 in the latest 12 months.

What kinds of events are reported?

injury (59.2%), malfunction (38.7%) and other (2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

device operates differently than expected (23.1%), no device output (17%), insufficient device problem information (14%), output problem (10.3%) and migration (10%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Vibrant Soundbridge 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.