Osia OSI300 Implant P1772248Recalls & reported problems
Cochlear Limited · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Cochlear Osia hearing implant has 803 adverse event reports, 786 describing injuries and no deaths. Many describe the device pushing out through the skin, skin breaking down over it, and infections, and some describe removal because of pain. No recalls name this device. Reports fell from 389 in the previous 12 months to 252 in the most recent 12 months.
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
- 837
- Deaths reported
- 0
- Injuries reported
- 820
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 837 adverse event reports that list this exact device (DI 09321502070676), received between Jan 15, 2024 and Sep 30, 2026 — classified as 820 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Expulsion” (298 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available475
- Expulsion298
- Insufficient Device Problem Information22
- Inadequacy of Device Shape and/or Size21
- Unexpected Therapeutic Results17
- Adverse Event Without Identified Device or Use Problem13
- Failure to Deliver Shock/Stimulation11
- Loss of Osseointegration11
Patient problems
- Tissue Breakdown283
- Unspecified Infection240
- Medical device site infection175
- Wound Dehiscence94
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available82
- Pain68
- Post Operative Wound Infection51
- Fluid Discharge49
Recent adverse event reports
The 25 most recent of 837 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Appropriate Device Problem Term/Code Not Available
Per the clinic, the patient experienced an infection and pain at implant site. Subsequently, the device was explanted on (b)(6) 2026. There are no plans to reimplant the patient with a new device 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: Medical device site infection; Pain
MAUDE report 50942245 ↗InjurySep 30, 2026Appropriate Device Problem Term/Code Not Available
Per the clinic, the patient experienced an infection and pain at implant site. Subsequently, the device was explanted on (b)(6) 2026. There are no plans to reimplant the patient with a new device 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: Medical device site infection; Pain
MAUDE report 50942244 ↗InjurySep 29, 2026Appropriate Device Problem Term/Code Not Available
Per the clinic, the patient experienced pain and infection at implant site. Subsequently, the device was explanted on (b)(6) 2026, and there are no plans to reimplant the patient with another cochlear device as of the date of this report.
Patient problems: Implant Pain; Medical device site infection
MAUDE report 50927533 ↗InjurySep 29, 2026Appropriate Device Problem Term/Code Not Available
Per the clinic, the patient experienced pain and infection at implant site. Subsequently, the device was explanted on (b)(6) 2026, and there are no plans to reimplant the patient with another cochlear device as of the date of this report.
Patient problems: Implant Pain; Medical device site infection
MAUDE report 50927509 ↗InjurySep 28, 2026Patient Device Interaction Problem
Per the clinic, the patient experienced a soft tissue complication and was treated with medication (specific class, type, date and duration not reported). However, the issue could not be resolved, and the device was explanted on (b)(6) 2026. Reimplantation is planned but has not taken place as of the date of this report.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50911499 ↗InjurySep 28, 2026Patient Device Interaction Problem
Per the clinic, the patient experienced a soft tissue complication and was treated with medication (specific class, type, date and duration not reported). However, the issue could not be resolved, and the device was explanted on (b)(6) 2026. Reimplantation is planned but has not taken place as of the date of this report.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50911498 ↗InjurySep 28, 2026Appropriate Device Problem Term/Code Not Available
Per the clinic, the patient experienced hematoma subsequent to sustaining a head trauma. Subsequently, the device was explanted (date not reported). It is unknown if there are plans to re-implant the patient as of the date of this report.
Patient problems: Head Injury; Hematoma
MAUDE report 50911025 ↗InjurySep 28, 2026Expulsion
Per the clinic, the patient experienced a wound dehiscence, exposing the receiver/stimulator subseqent of sustaining head trauma. 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: Head Injury; Tissue Breakdown; Wound Dehiscence
MAUDE report 50910952 ↗InjurySep 28, 2026Expulsion
Per the clinic, the patient experienced a wound dehiscence, exposing the receiver/stimulator subseqent of sustaining head trauma. 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: Head Injury; Tissue Breakdown; Wound Dehiscence
MAUDE report 50910946 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
Per the clinic, the device was explanted on (b)(6) 2026 due to reported pain/non-auditory sensations. There are no plans to reimplant the patient with a new device as of the date of this report.
Patient problems: Pain
MAUDE report 50877273 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
Per the clinic, the device was explanted on (b)(6) 2026 due to reported pain/non-auditory sensations. There are no plans to reimplant the patient with a new device as of the date of this report.
Patient problems: Pain
MAUDE report 50877272 ↗InjurySep 18, 2026Expulsion
Per the clinic, the patient experienced soft tissue breakdown, exposing the receiver-coil/transducer (specific date not reported). Subsequently, the device was explanted on (b)(6) 2026 and the patient underwent soft tissue closure within the same surgery. There are no plans to reimplant the patient with a new device 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: Tissue Breakdown
MAUDE report 50814633 ↗InjurySep 18, 2026Appropriate Device Problem Term/Code Not Available
Per the clinic, the device was explanted on (b)(6), 2026, due to an infection. There are no plans to reimplant the patient with a new device as of the date of this report.
Patient problems: Unspecified Infection
MAUDE report 50813947 ↗InjurySep 17, 2026Expulsion
Per the clinic, the patient developed an infection at the implant site, exposing the implant. The device was explanted on (b)(6) 2026. It is unknown if there are plans to explant the device and to re-implant the patient with a new device as of the date of this report.
Patient problems: Medical device site infection; Tissue Breakdown
MAUDE report 50799286 ↗InjurySep 15, 2026Expulsion
Per the clinic, the patient experienced skin breakdown at the edge of the coil, followed by device extrusion (specific date not reported). The patient was initially treated with oral antibiotics (specific date not reported) for 2 weeks but the issue could not be resolved. Subsequently, the device was explanted (specific date not reported). It is unknown if there are plans to reimplant the patient as of the date of this report. Additional information has been requested but it has not been made available as of the date of this report.
Patient problems: Tissue Breakdown
MAUDE report 50766822 ↗InjurySep 15, 2026Expulsion
Per the clinic, the patient experienced skin breakdown at the edge of the coil, followed by device extrusion (specific date not reported). The patient was initially treated with oral antibiotics (specific date not reported) for 2 weeks but the issue could not be resolved. Subsequently, the device was explanted (specific date not reported). It is unknown if there are plans to reimplant the patient as of the date of this report. Additional information has been requested but it has not been made available as of the date of this report.
Patient problems: Tissue Breakdown
MAUDE report 50766821 ↗InjurySep 11, 2026Signal Artifact/Noise; Failure to Deliver Shock/Stimulation
Per the clinic, the patient experienced no sound and only received static noise with the device use. The patient reported that the device moved under the skin, however, the device was actually firmly connected to the internal fixture and had not migrated. It was also reported that the patient requires multiple MRIs procedures. Subsequently, the device was explanted on (b)(6) 2026, and an abutment was placed on the internal fixture.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50727330 ↗InjurySep 11, 2026Signal Artifact/Noise; Failure to Deliver Shock/Stimulation
Per the clinic, the patient experienced no sound and only received static noise with the device use. The patient reported that the device moved under the skin, however, the device was actually firmly connected to the internal fixture and had not migrated. It was also reported that the patient requires multiple MRIs procedures. Subsequently, the device was explanted on (b)(6) 2026, and an abutment was placed on the internal fixture.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50727329 ↗InjurySep 11, 2026Expulsion
Per the clinic, the patient developed an infection (site of infection not confirmed), wound breakdown, and extrusion of the device. Subsequently, the patient was treated with an IV antibiotics during surgery, 2-week course of oral antibiotics (specific dates not reported) and topical antibiotics (specific date and duration not reported) to treat the reported issues.There are plans to explant the device; however, this has not occurred 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: Tissue Breakdown; Unspecified Infection
MAUDE report 50726118 ↗InjurySep 11, 2026Expulsion
Per the clinic, the patient developed an infection (site of infection not confirmed), wound breakdown, and extrusion of the device. Subsequently, the patient was treated with an IV antibiotics during surgery, 2-week course of oral antibiotics (specific dates not reported) and topical antibiotics (specific date and duration not reported) to treat the reported issues.There are plans to explant the device; however, this has not occurred 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: Tissue Breakdown; Unspecified Infection
MAUDE report 50726116 ↗InjurySep 11, 2026Patient-Device Incompatibility
Per the clinic, the implant was sitting proud beneath the skin, resulting in progressive thinning of the overlying skin and excruciating pain. Subsequently, the device was explanted on (b)(6) 2026, and the patient was re-implanted with another cochlear device during the same surgery.
Patient problems: Implant Pain
MAUDE report 50725479 ↗InjurySep 10, 2026Appropriate Device Problem Term/Code Not Available
Per the clinic, the patient developed infection at the incision site, and subsequently, was treated with IV antibiotics for 6 weeks (date not reported).
Patient problems: Post Operative Wound Infection
MAUDE report 50718484 ↗InjurySep 10, 2026Appropriate Device Problem Term/Code Not Available
Per the clinic, the device was explanted on (b)(6) 2026 due to infection.
Patient problems: Unspecified Infection
MAUDE report 50716006 ↗InjurySep 10, 2026Appropriate Device Problem Term/Code Not Available
Per the clinic, the device was explanted on (b)(6) 2026 due to infection.
Patient problems: Unspecified Infection
MAUDE report 50716003 ↗InjurySep 10, 2026Appropriate Device Problem Term/Code Not Available
Per the clinic, the patient developed infection at the incision site, and subsequently, was treated with IV antibiotics for 6 weeks (date not reported).
Patient problems: Post Operative Wound Infection
MAUDE report 50716001 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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