Baha 92126Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 09321502019514), received between Nov 14, 2017 and Sep 10, 2026 — classified as 27 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (7 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Patient Device Interaction Problem

  Per the clinic, the patient experienced skin overgrowth at the BAHA abutment site, which prevented attachment of the BAHA. Treatment with steroid cream was unsuccessful. Subsequently, the patient underwent revision surgery to remove the excess skin, and the granulation tissue was debrided on (b)(6) 2026. The existing abutment was then removed and replaced with a new 10 mm abutment. The topical antibiotics were given intra-operatively during the revision surgery. and a healing cap was placed.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50705713 ↗
• InjurySep 10, 2026Patient Device Interaction Problem

  Per the clinic, the patient experienced skin overgrowth at the BAHA abutment site, which prevented attachment of the BAHA. Treatment with steroid cream was unsuccessful. Subsequently, the patient underwent revision surgery to remove the excess skin, and the granulation tissue was debrided on (b)(6) 2026. The existing abutment was then removed and replaced with a new 10 mm abutment. The topical antibiotics were given intra-operatively during the revision surgery. and a healing cap was placed.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50705712 ↗
• InjuryAug 19, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED A CONSTANT SKIN INFECTIONS AROUND THE ABUTMENT. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED), HOWEVER, THE ISSUE DID NOT RESOLVE. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA (SPECIFIC DATE NOT REPORTED) IN ORDER TO REMOVE THE ABUTMENT. REVISION SURGERY TO CONVERT THE PATIENT TO A TRANSCUTANEOUS OSIA IMPLANT SYSTEM IS PLANNED BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT. THE IMPLANTED DEVICE REMAINS.

  Patient problems: Skin Infection

  MAUDE report 22836513 ↗
• InjuryAug 16, 2025Loss of Osseointegration; Loss of Osseointegration

  PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS. RE-IMPLANTATION IS PLANNED BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22823180 ↗
• InjuryOct 2, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE ABUTMENT SITE. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH TOPICAL STEROID AND ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED).

  Patient problems: Skin Infection

  MAUDE report 17858202 ↗
• InjuryOct 2, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE ABUTMENT SITE. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH TOPICAL STEROID AND ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED).

  Patient problems: Skin Infection

  MAUDE report 17858201 ↗
• InjuryAug 20, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED BLOOD AND INFECTION AT THE IMPLANT SITE. THE IMPLANTED DEVICE REMAINS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Infection

  MAUDE report 17581482 ↗
• InjuryApr 16, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AND TISSUE OVERGROWTH AT THE ABUTMENT SITE. THE PATIENT WAS TREATED WITH TOPICAL STEROID AND ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED).

  Patient problems: Impaired Healing; Unspecified Infection

  MAUDE report 16748658 ↗
• InjuryApr 16, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AND TISSUE OVERGROWTH AT THE ABUTMENT SITE. THE PATIENT WAS TREATED WITH TOPICAL STEROID AND ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED).

  Patient problems: Impaired Healing; Unspecified Infection

  MAUDE report 16748657 ↗
• InjurySep 9, 2022Loss of Osseointegration; Appropriate Device Problem Term/Code Not Available; Loss of Osseointegration; Appropriate Device Problem Term/Code Not Available

  CORRECTION: THE INITIAL MDR SUBMITTED ON SEPTEMBER 9, 2022, WAS FILED INADVERTENTLY. NO REVISION SURGERY HAS OCCURRED. THE CORRECT D1 AND D4 HAS BEEN UPDATED TO BIA300 IMPLANT 3MM W ABUTMENT 6MM AND 92126 RESPECTIVELY. PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS. THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE ON (B)(6) 2022.

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 15388517 ↗
• InjurySep 9, 2022Loss of Osseointegration; Appropriate Device Problem Term/Code Not Available; Loss of Osseointegration; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT UNDERWENT REVISION SURGERY (DATE NOT REPORTED). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 15388500 ↗
• InjuryNov 7, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED A SOFT TISSUE OVERGROWTH ON THE ABUTMENT. SUBSEQUENTLY, THE PATIENT UNDERWENT A SKIN REVISION SURGERY UNDER GENERAL ANESTHESIA ON (B)(6) 2014. THE IMPLANTED DEVICE REMAINS.

  Patient problems: Impaired Healing

  MAUDE report 12764053 ↗
• InjuryNov 7, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED A SOFT TISSUE OVERGROWTH ON THE ABUTMENT. SUBSEQUENTLY, THE PATIENT UNDERWENT A SKIN REVISION SURGERY UNDER GENERAL ANESTHESIA ON (B)(6) 2014. THE IMPLANTED DEVICE REMAINS.

  Patient problems: Impaired Healing

  MAUDE report 12764045 ↗
• InjuryOct 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER THE CLINIC, PATIENT EXPERIENCED GRANULATION AT THE IMPLANT SITE RESULTING IN INFLAMMATION OF THE WOUND AND SUBSEQUENTLY, WAS TREATED WITH AN OINTMENT AND IV ANTIBIOTICS (DATE AND DURATION NOT REPORTED). HOWEVER, THE ISSUE COULD NOT BE RESOLVED AND THE DEVICE WAS EXPLANTED ON (B)(6) 2021.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 12567499 ↗
• InjuryMar 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH AND CELLULITIS AT THE ABUTMENT SITE WHICH WAS TREATED WITH A TOPICAL ANTIBIOTIC. DURING THE ABUTMENT CHANGE ON (B)(6) 2021. THERE WAS A SKIN REVISION UNDER A GENERAL ANAESTHETIC.

  Patient problems: Cellulitis; Unspecified Infection

  MAUDE report 11468140 ↗
• InjuryMar 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH AND CELLULITIS AT THE ABUTMENT SITE WHICH WAS TREATED WITH A TOPICAL ANTIBIOTIC. DURING THE ABUTMENT CHANGE ON (B)(6) 2021. THERE WAS A SKIN REVISION UNDER A GENERAL ANAESTHETIC.

  Patient problems: Cellulitis; Unspecified Infection

  MAUDE report 11468136 ↗
• InjuryMay 12, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE AUDIOLOGIST, THE PATIENT EXPERIENCED A SKIN OVERGROWTH AT THE ABUTMENT SITE AND SUBSEQUENTLY WAS ADMINISTERED STEROIDS BY INJECTION IN (B)(6) 2018.

  Patient problems: Host-Tissue Reaction

  MAUDE report 8602450 ↗
• InjuryApr 18, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE SURGEON, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2019, IN ORDER TO CONVERT THE PATIENT TO A PERCUTANEOUS BAHA IMPLANT SYSTEM. DURING THE PROCEDURE, THE ABUTMENT WAS REMOVED AND A MAGNET WAS PLACED ON THE INTERNAL FIXTURE.

  Patient problems: No Code Available

  MAUDE report 8525748 ↗
• InjuryJan 8, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH AT ABUTMENT SITE; SUBSEQUENTLY THE PATIENT UNDERWENT SKIN REVISION SURGERY TO EXCISE SKIN AT ABUTMENT SITE AND WAS PLACED ON ANTIBIOTICS (DATE AND DURATION NOT REPORTED).

  Patient problems: Host-Tissue Reaction

  MAUDE report 8229507 ↗
• InjurySep 5, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE AUDIOLOGIST, IT WAS REPORTED THAT THE PATIENT EXPERIENCED RECURRENT INFECTIONS AT THE ABUTMENT SITE. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY (DATE NOT REPORTED) IN ORDER TO HAVE A MAGNET PLACED ON THE INTERNAL FIXTURE, CONVERTING THE PATIENT TO A SUBCUTANEOUS BAHA IMPLANT SYSTEM.

  Patient problems: Unspecified Infection

  MAUDE report 7845002 ↗
• InjuryAug 8, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE AUDIOLOGIST, IT WAS REPORTED THAT THE PATIENT EXPERIENCED SKIN OVERGROWTH AT THE ABUTMENT SITE AND SUBSEQUENTLY UNDERWENT A SKIN REVISION ON (B)(6) 2018.

  Patient problems: Host-Tissue Reaction

  MAUDE report 7760696 ↗
• InjuryJun 12, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH ON THE ABUTMENT. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY (DATE NOT REPORTED), UNDER GENERAL ANESTHETIC, TO REMOVE THE EXCESS SKIN AND PLACE A LONGER ABUTMENT.

  Patient problems: Host-Tissue Reaction

  MAUDE report 7590064 ↗
• InjuryMay 16, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT DEVELOPED CELLULITIS AT THE IMPLANT SITE AND WAS TREATED WITH ANTIBIOTICS (TYPE NOT REPORTED) ON (B)(6) 2015. ON (B)(6) 2015, THE PATIENT EXPERIENCED SKIN OVERGROWTH AT THE IMPLANT SITE. SUBSEQUENTLY, A BIOPSY PUNCH WAS PERFORMED IN ORDER TO EXPOSE THE IMPLANT. ON (B)(6) 2016, THE PATIENT EXPERIENCED AN INFECTION AT THE IMPLANT SITE, AND WAS TREATED WITH ORAL ANTIBIOTICS; HOWEVER, THE ISSUE REOCCURRED, AND THE PATIENT PRESENTED ONCE MORE TO CLINIC ON (B)(6) 2016, WITH INFECTION. THE PATIENT WAS TREATED WITH ANOTHER COURSE OF ORAL ANTIBIOTICS.

  Patient problems: Bacterial Infection; Cellulitis; Purulent Discharge

  MAUDE report 7521086 ↗
• InjuryFeb 8, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE PATIENT EXPERIENCED DISCOMFORT WITH DEVICE RESULTING IN NON-USE OF THE DEVICE. THE PATIENT WAS TREATED WITH ANTIBIOTICS (TYPE NOT REPORTED). SUBSEQUENTLY, THE ABUTMENT WAS REMOVED UNDER A GENERAL ANAESTHETIC ON (B)(6) 2018.

  Patient problems: Discomfort

  MAUDE report 7250554 ↗
• InjuryJan 24, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED PAIN AT ABUTMENT SITE HOWEVER THE ISSUE COULD NOT BE RESOLVED. SUBSEQUENTLY ON (B)(6) 2018, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA TO REMOVE THE ABUTMENT. THE IMPLANTED DEVICE REMAINS.

  Patient problems: Pain

  MAUDE report 7217376 ↗