Baha 92129Recalls & reported problems
Cochlear Bone Anchored Solutions AB · BI300 implant 4 mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Baha bone-conduction hearing implant is a bone-anchored hearing device. Most of the 127 reports describe the implant failing to bond with the bone, sometimes leading to fixture loss, and some describe infections, with several implants removed. The reports include no deaths and 126 injuries. Reports fell to 6 in the last 12 months from 11 in the previous 12. 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
- 127
- Deaths reported
- 0
- Injuries reported
- 126
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 09321502019545), received between Aug 3, 2017 and May 28, 2026 — classified as 126 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loss of Osseointegration” (22 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 Available63
- Loss of Osseointegration22
- Adverse Event Without Identified Device or Use Problem19
- Patient Device Interaction Problem17
- Failure to Osseointegrate4
- Insufficient Device Problem Information3
- Patient-Device Incompatibility2
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- No Code Available23
- Unspecified Infection16
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available12
- Inadequate Osseointegration12
- No Clinical Signs, Symptoms or Conditions12
- Patient Problem/Medical Problem11
- Skin Infection10
- Bacterial Infection8
Recent adverse event reports
The 25 most recent of 127 reports, in the reporter's own words as published by the FDA.
InjuryMay 28, 2026Failure to Osseointegrate
PER THE CLINIC, THE PATIENT EXPERIENCED LACK OF OSSEOINTEGRATION (SPECIFIC DATE NOT REPORTED). SUBSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2026, AND THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.
Patient problems: Inadequate Osseointegration
MAUDE report 25312045 ↗InjuryMay 28, 2026Failure to Osseointegrate
PER THE CLINIC, THE PATIENT EXPERIENCED LACK OF OSSEOINTEGRATION (SPECIFIC DATE NOT REPORTED). SUBSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2026, AND THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.
Patient problems: Inadequate Osseointegration
MAUDE report 25312044 ↗InjuryMay 26, 2026Loosening of Implant Not Related to Bone-Ingrowth
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION (SPECIFIC DATE NOT REPORTED) SUBSEQUENT TO SUSTAINING A HEAD TRAUMA. IT IS UNKNOWN IF THERE ARE PLANS TO RE-IMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT.
Patient problems: Head Injury; Inadequate Osseointegration
MAUDE report 25273734 ↗InjuryApr 16, 2026Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.
Patient problems: Inadequate Osseointegration
MAUDE report 24892403 ↗InjuryApr 16, 2026Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS. IT IS UNKNOWN IF THERE ARE PLANS TO RE-IMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.
Patient problems: Inadequate Osseointegration
MAUDE report 24892402 ↗InjuryFeb 14, 2026Adverse Event Without Identified Device or Use Problem
PER THE CLINIC, THE BI300 IMPLANT SCREW WAS EXPLANTED UNDER GENERAL ANESTHESIA ON (B)(6) 2026, IN ORDER TO HAVE A NEW IMPLANT SCREW RESITED FOR PLACING THE REPOSITIONED OSIA IMPLANT. THE PATIENT WAS REIMPLANTED WITH A NEW BI300 IMPLANT SCREW AT A NEW SITE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24340533 ↗InjuryOct 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT DEVELOPED A STAPHYLOCOCCUS AUREUS INFECTION AND SUBSEQUENTLY THE DEVICE HAS BEEN EXPLANTED ON (B)(6) 2025. THERE ARE NO PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.
Patient problems: Bacterial Infection
MAUDE report 23355540 ↗InjuryOct 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT DEVELOPED A STAPHYLOCOCCUS AUREUS INFECTION AND SUBSEQUENTLY THE DEVICE HAS BEEN EXPLANTED ON (B)(6) 2025. THERE ARE NO PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.
Patient problems: Bacterial Infection
MAUDE report 23355538 ↗InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PER THE CLINIC, THE IMPLANT SCREW WAS ELECTIVELY EXPLANTED ON (B)(6) 2025 UNDER GENERAL ANESTHESIA. SUBSEQUENTLY, THE PATIENT WAS RE-IMPLANTED WITH A TRANSCUTANEOUS OSIA IMPLANT SYSTEM AT NEW SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22208819 ↗InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PER THE CLINIC, THE IMPLANT SCREW WAS ELECTIVELY EXPLANTED ON (B)(6) 2025 UNDER GENERAL ANESTHESIA. SUBSEQUENTLY, THE PATIENT WAS RE-IMPLANTED WITH A TRANSCUTANEOUS OSIA IMPLANT SYSTEM AT NEW SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22208818 ↗InjuryJun 9, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT EXPERIENCED CHRONIC PAIN FROM THE IMPLANT (SPECIFIC DATE NOT REPORTED). SUBSEQUENTLY, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2025, WHERE IMPLANT WAS EXPLANTED. THE ABUTMENT WAS ALSO REMOVED DURING THE SAME SURGERY AND THE SITE WAS SUTURED OFF.
Patient problems: Implant Pain
MAUDE report 22173139 ↗InjuryMay 8, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2025, DUE TO INSUFFICIENT BENEFIT WITH THE ATTRACT SYSTEM. THE PATIENT WAS RE-IMPLANTED WITH A TRANSCUTANEOUS OSIA IMPLANT SYSTEM DURING THE SAME SURGERY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21983447 ↗InjuryMar 5, 2025Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS (SPECIFIC DATE NOT REPORTED). IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT.
Patient problems: Inadequate Osseointegration
MAUDE report 21521773 ↗InjuryMar 5, 2025Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS (SPECIFIC DATE NOT REPORTED). IT IS UNKNOWN IF THERE ARE PLANS TO RE-IMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT.
Patient problems: Inadequate Osseointegration
MAUDE report 21521772 ↗InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PER THE CLINIC, IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 TO EXPLANT THE DEVICE AND CONVERT TO A TRANSCUTANEOUS OSIA IMPLANT SYSTEM FOR AN UPGRADE TO A NEWER TECHNOLOGY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21394490 ↗InjuryNov 19, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN INFECTION (OPEN SKIN) AT THE IMPLANT SITE. SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED (DATE NOT REPORTED) AND WAS TREATED WITH IV ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED). HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED ON (B)(6) 2024 . IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT.
Patient problems: Skin Infection
MAUDE report 20730824 ↗InjuryNov 4, 2024Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Inadequate Osseointegration
MAUDE report 20596315 ↗InjuryJul 5, 2024Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT IMPLANT SITE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Skin Infection; Unspecified Infection
MAUDE report 19679274 ↗InjuryJul 5, 2024Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT IMPLANT SITE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Skin Infection; Unspecified Infection
MAUDE report 19678544 ↗InjuryDec 20, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED PAIN AND IRRITATION AT THE IMPLANT SITE. SUBSEQUENTLY, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2023 IN ORDER TO EXPLANT THE INTERNAL FIXTURE.
Patient problems: Pain; Skin Inflammation/ Irritation
MAUDE report 18370363 ↗InjuryDec 20, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED PAIN AND IRRITATION AT THE IMPLANT SITE. SUBSEQUENTLY, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2023 IN ORDER TO EXPLANT THE INTERNAL FIXTURE.
Patient problems: Pain; Skin Inflammation/ Irritation
MAUDE report 18370362 ↗InjuryDec 17, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED RECURRENT INFECTIONS AT THE IMPLANT SITE. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH STEROID INJECTIONS IN (B)(6) 2023 (SPECIFIC DATE NOT REPORTED); AND ORAL AND TOPICAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED).
Patient problems: Skin Infection
MAUDE report 18342351 ↗InjuryDec 17, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED RECURRENT INFECTIONS AT THE IMPLANT SITE. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH STEROID INJECTIONS IN (B)(6) 2023 (SPECIFIC DATE NOT REPORTED); AND ORAL AND TOPICAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED).
Patient problems: Skin Infection
MAUDE report 18342350 ↗InjuryDec 15, 2023Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS. THE PATIENT WAS RE-IMPLANTED WITH ANOTHER COCHLEAR DEVICE ON (B)(6) 2023.
Patient problems: Inadequate Osseointegration
MAUDE report 18333652 ↗InjuryDec 11, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE DEVICE WAS EXPLANTED UNDER GENERAL ANESTHESIA ON (B)(6) 2023, DUE TO WANTING TO IMPROVE SOUND OUTCOMES. THE PATIENT WAS RE-IMPLANTED WITH A TRANSCUTANEOUS OSIA IMPLANT SYSTEM DURING THE SAME SURGERY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18307954 ↗
Other Hearing aid, bone conduction devices
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- Baha 92127Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction55 reports
- Baha 90434Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction54 reports
- Baha 5 Sound Processor Tamper-proof battery door 3 pcs P1129017Cochlear Limited · Hearing aid, bone conduction1 recall0 reports
- Baha 92346Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction49 reports
- Baha 92126Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction27 reports
- Baha 92133Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction21 reports
- Baha 92132Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction9 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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