Cochlear P1170466Recalls & reported problems
Cochlear Limited · Cochlear Osia OSI200 Implant · Class 2 · Implant
Quick summary
This Cochlear Osia implant is an implanted bone conduction hearing system. Among the 1,348 reports, some describe the implant being pushed out of the body, sometimes with tissue breakdown or infection, and others describe pain or the implant magnet losing hold. The reports include 1 death, 1,292 injuries and 55 malfunctions. Reports fell from 247 in the prior 12 months to 119 in the latest 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 1,365
- Deaths reported
- 1
- Injuries reported
- 1,307
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,365 adverse event reports that list this exact device (DI 09321502046152), received between Feb 4, 2020 and Sep 30, 2026 — classified as 1 death, 1,307 injuries, 57 malfunctions.
The most frequently reported specific device problem is “Expulsion” (313 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available651
- Expulsion313
- Adverse Event Without Identified Device or Use Problem203
- Insufficient Device Problem Information65
- Device Dislodged or Dislocated60
- Unexpected Therapeutic Results33
- Device Appears to Trigger Rejection28
- Output Problem17
Patient problems
- Unspecified Infection298
- Tissue Breakdown289
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available287
- No Clinical Signs, Symptoms or Conditions156
- Wound Dehiscence142
- Pain133
- Insufficient Information77
- Necrosis51
Recent adverse event reports
The 25 most recent of 1,365 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Therapeutic or Diagnostic Output Failure
Per the clinic, the patient experienced pain/non-auditory sensations, discomfort and lack of benefit from the device. The patient was also unable to undergo the necessary MRI imaging with the device in situ. Subsequently, the device was explanted on (b)(6) 2026, and there are no plans to re-implant the patient with a new device as of the date of this report.
Patient problems: Discomfort; Pain
MAUDE report 50942105 ↗InjurySep 30, 2026Therapeutic or Diagnostic Output Failure
Per the clinic, the patient experienced pain/non-auditory sensations, discomfort and lack of benefit from the device. The patient was also unable to undergo the necessary MRI imaging with the device in situ. Subsequently, the device was explanted on (b)(6) 2026, and there are no plans to reimplant the patient with a new device as of the date of this report.
Patient problems: Discomfort; Pain
MAUDE report 50942104 ↗InjurySep 25, 2026Insufficient Device Problem Information
Per the clinic, the device was explanted (specific date not reported) due to unknown reason. It is unknown if there are plans to reimplant the patient as of the date of this report. Additional information has been requested but has not been made available as of the date of this report.
Patient problems: Insufficient Information
MAUDE report 50893079 ↗InjurySep 25, 2026Insufficient Device Problem Information
Per the clinic, the device was explanted (specific date not reported) due to unknown reason. It is unknown if there are plans to reimplant the patient as of the date of this report. Additional information has been requested but has not been made available as of the date of this report.
Patient problems: Insufficient Information
MAUDE report 50893076 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
Per the clinic, the device was explanted on (b)(6) 2026, to allow for an upgrade to an MRI-compatible device. The patient was reimplanted with another cochlear device during the same surgery.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50879914 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
Per the clinic, the device was explanted on (b)(6) 2026, to allow for an upgrade to an MRI-compatible device. The patient was re-implanted with another cochlear device during the same surgery.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50879912 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
Per the clinic, the patient experienced hearing changes that led to no longer being a candidate for the transcutaneous Osia Implant System. The device was explanted on (b)(6) 2026, and the patient was reimplanted with another cochlear device during the same surgery.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50878200 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
Per the clinic, the patient experienced hearing changes that led to no longer being a candidate for the transcutaneous Osia Implant System. The device was explanted on (b)(6) 2026, and the patient was reimplanted with another cochlear device during the same surgery.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50878199 ↗InjurySep 18, 2026Expulsion
Per the clinic, the patient experienced bacterial infection, skin breakdown, extrusion of receiver-stimulator at the implant site and subsequently was treated with IV and oral antibiotics (specific date and duration not reported). The device was explanted on (b)(6) 2026. It is unknown if there are plans to reimplant the patient as of the date of this report.
Patient problems: Bacterial Infection; Medical device site infection; Tissue Breakdown
MAUDE report 50818657 ↗InjurySep 18, 2026Appropriate Device Problem Term/Code Not Available
Per the clinic, the device was explanted on (b)(6), 2026 due to ongoing pain and headaches. It is unknown if there are plans to reimplant the patient as of the date of this report.
Patient problems: Headache; Pain
MAUDE report 50814946 ↗InjurySep 18, 2026Appropriate Device Problem Term/Code Not Available
Per the clinic, the device was explanted on (b)(6) 2026 due to ongoing pain and headaches. It is unknown if there are plans to reimplant the patient as of the date of this report.
Patient problems: Headache; Pain
MAUDE report 50814943 ↗InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem
Per the clinic, the device was electively explanted due to device non-use on (b)(6) 2026. There are no plans to reimplant the patient with a new device as of the date of this report.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50725866 ↗InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem
Per the clinic, the device was electively explanted due to device non-use on (b)(6) 2026. There are no plans to reimplant the patient with a new device as of the date of this report.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50725865 ↗MalfunctionSep 1, 2026Failure to Read Input Signal; Intermittent Shock/Stimulation
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50536366 ↗MalfunctionSep 1, 2026Failure to Read Input Signal; Intermittent Shock/Stimulation
Per the clinic, the patient experienced intermittent sound with the external device and during troubleshooting, the Aud could not establish connection with implanted device. Hardware exchange was attempted, but the issue persisted. The device remains implanted. There are plans to explant the device and to reimplant the patient with a new device; however, this has not occurred as of the date of this report.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50536365 ↗InjuryAug 28, 2026Expulsion
Per the clinic, the patient experienced pain and extrusion of the implanted device. The device was explanted on (b)(6) 2026, and during the surgical procedure, revitalization of the wound margins in the necrotic zone was performed and the dissected area sutured with Monocryl. It is unknown if there are plans to reimplant the patient as of the date of this report. Additional information has been requested but has not been made available as of the date of this report.
Patient problems: Necrosis; Pain; Tissue Breakdown
MAUDE report 50490213 ↗InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem
Per the clinic, the device was electively explanted on (b)(6) 2026, due to patient requiring bi-annual MRI imaging for pituitary mass surveillance. There are no plans to reimplant the patient with a new device as of the date of this report.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50052729 ↗InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem
Per the clinic, the device was electively explanted on (b)(6) 2026, due to patient requiring bi-annual MRI imaging for pituitary mass surveillance. There are no plans to reimplant the patient with a new device as of the date of this report.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50052728 ↗InjuryMay 21, 2026Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT EXPERIENCED HEADACHES AND PAIN AROUND THE IMPLANT COIL SITE WITH AND WITHOUT DEVICE USE SINCE INITIAL IMPLANTATION ON (B)(6) 2022. THE PATIENT WAS THEN PRESCRIBED WITH PAIN MEDICATIONS WHICH HELPS WITH THE SYMPTOMS. THE PATIENT ALSO EXPERIENCED A HEATING SENSATION WITH THE DEVICE USE, WHICH IMPROVED AFTER SWITCHING TO A LOWER STRENGTH EXTERNAL MAGNET. HOWEVER, THE PAIN AROUND THE IMPLANT SITE RECURRED WHICH LEADS TO THE DECISION TO EXPLANT THE DEVICE. THE DEVICE WAS EXPLANTED ON (B)(6) 2026. DURING THE PROCEDURE, THE SURGEON REPORTED THAT THE TRANSCUTANEOUS IMPLANT IS LOOSE AND THAT THERE WAS NO TORQUE AT ALL. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Headache; Implant Pain; Skin Burning Sensation
MAUDE report 25242399 ↗InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem
PER THE CLINIC, THE DEVICE WAS ELECTIVELY EXPLANTED ON (B)(6) 2025, DUE TO DEVICE NON-USE. THERE ARE NO PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25226254 ↗InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem
PER THE CLINIC, THE DEVICE WAS ELECTIVELY EXPLANTED ON (B)(6) 2025, DUE TO DEVICE NON-USE. THERE ARE NO PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25226253 ↗InjuryMay 17, 2026Adverse Event Without Identified Device or Use Problem
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2026, DUE TO REQUIRING A MORE MRI-COMPATIBLE DEVICE. THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25196831 ↗InjuryMay 17, 2026Adverse Event Without Identified Device or Use Problem
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2026, DUE TO REQUIRING A MORE MRI-COMPATIBLE DEVICE. THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25196830 ↗InjuryMay 5, 2026Inadequacy of Device Shape and/or Size
PER THE CLINIC, THE RECIPIENT EXPERIENCED A TRAUMATIC INCIDENT AFFECTING THE IMPLANT MAGNET, RESULTING IN POOR MAGNET RETENTION. CONSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2026.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25076551 ↗InjuryMay 5, 2026Inadequacy of Device Shape and/or Size
PER THE CLINIC, THE RECIPIENT EXPERIENCED A TRAUMATIC INCIDENT AFFECTING THE IMPLANT MAGNET, RESULTING IN POOR MAGNET RETENTION. CONSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2026.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25076528 ↗
Other Active implantable bone conduction hearing system devices
- Osia OSI300 Implant P1772248Cochlear Limited · Active implantable bone conduction hearing system837 reports
- BCI 602 Kit 52483Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Active Implantable Bone Conduction Hearing System159 reports
- BCI Bone Conduction Implant Kit 52180Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Active Implantable Bone Conduction Hearing System9 reports
- BCI Bone Conduction Implant Kit 51032Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Implantable Bone Conduction Hearing Aid4 reports
- Sentio 186323Oticon Medical AB · Active Implantable Bone Conduction Hearing System4 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.