Baha 93330Recalls & reported problems
Cochlear Bone Anchored Solutions AB · BIA400 Implant 4mm w Abutment 8mm · Class 2 · Implant
Quick summary
This Cochlear Baha bone-anchored hearing implant appears in 267 adverse event reports, with no deaths and 267 injuries. The reports mostly describe skin overgrowth, infection and irritation around the abutment, with some removals and replacements, and some patients no longer benefiting from the device. Reports fell to 19 in the last 12 months from 33 in the year before. 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
- 269
- Deaths reported
- 0
- Injuries reported
- 269
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 269 adverse event reports that list this exact device (DI 09321502022705), received between Jul 16, 2017 and Sep 29, 2026 — classified as 269 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (70 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 Available125
- Patient Device Interaction Problem70
- Loss of Osseointegration44
- Adverse Event Without Identified Device or Use Problem25
- Insufficient Device Problem Information3
- Biocompatibility2
- Inadequacy of Device Shape and/or Size2
- No Apparent Adverse Event2
Patient problems
- Skin Infection40
- Unspecified Infection40
- Impaired Healing37
- Bacterial Infection31
- No Code Available25
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available23
- Host-Tissue Reaction23
- Patient Problem/Medical Problem20
Recent adverse event reports
The 25 most recent of 269 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Patient Device Interaction Problem
Per the clinic, the patient experienced skin overgrowth at the abutment site. Subsequently, the patient underwent skin revision surgery involving a biopsy punch and abutment replacement procedure under general anesthesia on (b)(6) 2026.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50927522 ↗InjurySep 29, 2026Patient Device Interaction Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50927519 ↗InjuryAug 27, 2026Patient Device Interaction Problem
Per the clinic, the patient experienced infection and skin overgrowth at the abutment site and subsequently was treated with oral antibiotics (specific date and duration not reported). Additional information has been requested but has not been made available as of the date of this report.
Patient problems: Skin Infection
MAUDE report 50470238 ↗InjuryAug 27, 2026Patient Device Interaction Problem
Per the clinic, the patient experienced infection and skin overgrowth at the abutment site and subsequently was treated with oral antibiotics (specific date and duration not reported). Additional information has been requested but has not been made available as of the date of this report.
Patient problems: Skin Infection
MAUDE report 50470236 ↗InjuryMay 14, 2026Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT REPORTEDLY NO LONGER EXPERIENCED BENEFIT FROM THE DEVICE. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2026. IT IS UNKNOWN IF THERE ARE 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 25167564 ↗InjuryApr 29, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH AT THE ABUTMENT SITE. AS A RESULT, THE ABUTMENT WAS REMOVED AND REPLACED UNDER GENERAL ANAESTHESIA ON (B)(6) 2026.
Patient problems: Impaired Healing
MAUDE report 25030092 ↗InjuryApr 29, 2026Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH AND IRRITATION. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2025, IN ORDER TO TRANSITION THE PATIENT TO A TRANSCUTANEOUS OSIA IMPLANT SYSTEM. THE IMPLANT WAS PLACED ON A NEW INTERNAL FIXTURE. THE OLD INTERNAL FIXTURE WAS LEFT IN-SITU. DURING THE PROCEDURE, THE ABUTMENT WAS REMOVED AND SKIN REVISION WAS PERFORMED UNDER GENERAL ANESTHESIA.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 25029975 ↗InjuryApr 29, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH AT THE ABUTMENT SITE. AS A RESULT, THE ABUTMENT WAS REMOVED AND REPLACED UNDER GENERAL ANAESTHESIA ON (B)(6) 2026.
Patient problems: Impaired Healing
MAUDE report 25024971 ↗InjuryApr 29, 2026Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH AND IRRITATION. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2025, IN ORDER TO TRANSITION THE PATIENT TO A TRANSCUTANEOUS OSIA IMPLANT SYSTEM. THE IMPLANT WAS PLACED ON A NEW INTERNAL FIXTURE. THE OLD INTERNAL FIXTURE WAS LEFT IN-SITU. DURING THE PROCEDURE, THE ABUTMENT WAS REMOVED AND SKIN REVISION WAS PERFORMED UNDER GENERAL ANESTHESIA.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 25024342 ↗InjuryApr 14, 2026Insufficient Device Problem Information
PER THE CLINIC, THE DEVICE WAS EXPLANTED (DATE NOT REPORTED) DUE TO UNKNOWN REASON. THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24880366 ↗InjuryMar 12, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AND 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: Skin Infection
MAUDE report 24580051 ↗InjuryMar 12, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AND 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: Skin Infection
MAUDE report 24577350 ↗InjuryMar 8, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED INFECTION AT THE ABUTMENT SITE WITH ASSOCIATED TISSUE OVERGROWTH AROUND THE SITE. THERE ARE PLANS TO EXPLANT THE DEVICE AND RE-IMPLANT THE PATIENT WITH A NEW 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: Impaired Healing; Skin Infection
MAUDE report 24542257 ↗InjuryFeb 26, 2026Patient Device Interaction Problem
PER THE CLINIC, ON (B)(6) 2022, THE PATIENT EXPERIENCED SOFT-TISSUE OVERGROWTH, CELLULITIS AND INFECTION AT THE IMPLANT SITE. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS AND TOPICAL STEROIDS (DURATION NOT REPORTED). ON (B)(6) 2023, THE IMPROVEMENT AT THE IMPLANT SITE WAS OBSERVED, WITH RESOLUTION OF SOFT-TISSUE OVERGROWTH AND CELLULITIS. ON (B)(6) 2023, IT WAS REPORTED THAT THE PATIENT WAS NOT USING THE SOUND PROCESSOR CONSISTENTLY. ON (B)(6) 2025, THE SOFT-TISSUE OVERGROWTH HAS BEEN NOTED AGAIN DUE TO THE NON-USE OF THE SOUND PROCESSOR. SUBSEQUENTLY, THE ABUTMENT SCREW WAS REMOVED UNDER LOCAL ANESTHESIA AND THE PATIENT WAS TREATED WITH TOPICAL STEROIDS FOR 60 DAYS. THE INTERNAL FIXTURE REMAINS IMPLANTED.
Patient problems: Cellulitis; Impaired Healing; Skin Infection
MAUDE report 24454854 ↗InjuryFeb 26, 2026Patient Device Interaction Problem
PER THE CLINIC, ON (B)(6) 2022, THE PATIENT EXPERIENCED SOFT-TISSUE OVERGROWTH, CELLULITIS AND INFECTION AT THE IMPLANT SITE. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS AND TOPICAL STEROIDS (DURATION NOT REPORTED). ON (B)(6) 2023, THE IMPROVEMENT AT THE IMPLANT SITE WAS OBSERVED, WITH RESOLUTION OF SOFT-TISSUE OVERGROWTH AND CELLULITIS. ON (B)(6) 2023, IT WAS REPORTED THAT THE PATIENT WAS NOT USING THE SOUND PROCESSOR CONSISTENTLY. ON (B)(6) 2025, THE SOFT-TISSUE OVERGROWTH HAS BEEN NOTED AGAIN DUE TO THE NON-USE OF THE SOUND PROCESSOR. SUBSEQUENTLY, THE ABUTMENT SCREW WAS REMOVED UNDER LOCAL ANESTHESIA AND THE PATIENT WAS TREATED WITH TOPICAL STEROIDS FOR 60 DAYS. THE INTERNAL FIXTURE REMAINS IMPLANTED.
Patient problems: Cellulitis; Impaired Healing; Skin Infection
MAUDE report 24454852 ↗InjuryFeb 25, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION (CELLULITIS) AND SKIN OVERGROWTH AROUND THE ABUTMENT. SUBSEQUENTLY, WAS TREATED WITH TOPICAL AND ORAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED). THE PATIENT UNDERWENT ABUTMENT REMOVAL PROCEDURE ON (B)(6) 2026.
Patient problems: Cellulitis; Impaired Healing; Skin Infection
MAUDE report 24438882 ↗InjuryFeb 25, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION (CELLULITIS) AND SKIN OVERGROWTH AROUND THE ABUTMENT. SUBSEQUENTLY, WAS TREATED WITH TOPICAL AND ORAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED). THE PATIENT UNDERWENT ABUTMENT REMOVAL PROCEDURE ON (B)(6) 2026.
Patient problems: Cellulitis; Impaired Healing; Skin Infection
MAUDE report 24438880 ↗InjuryDec 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED CHRONIC SKIN INFLAMMATION, LOCALIZED CELLULITIS AND PAIN AROUND THE ABUTMENTS. SUBSEQUENTLY, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2025, IN ORDER TO CONVERT THE PATIENT TO A TRANSCUTANEOUS OSIA IMPLANT SYSTEM. DURING THE PROCEDURE, THE ABUTMENT WAS REMOVED AND AN IMPLANT WAS PLACED ON THE INTERNAL FIXTURE. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT MINOR SKIN REVISION USING LOCAL FLAPS DURING THE SAME SURGERY.
Patient problems: Cellulitis; Pain; Skin Inflammation/ Irritation
MAUDE report 23919408 ↗InjuryDec 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED CHRONIC SKIN INFLAMMATION, LOCALIZED CELLULITIS AND PAIN AROUND THE ABUTMENTS. SUBSEQUENTLY, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2025, IN ORDER TO CONVERT THE PATIENT TO A TRANSCUTANEOUS OSIA IMPLANT SYSTEM. DURING THE PROCEDURE, THE ABUTMENT WAS REMOVED AND AN IMPLANT WAS PLACED ON THE INTERNAL FIXTURE. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT MINOR SKIN REVISION USING LOCAL FLAPS DURING THE SAME SURGERY.
Patient problems: Cellulitis; Pain; Skin Inflammation/ Irritation
MAUDE report 23919405 ↗InjuryDec 11, 2025No Apparent Adverse Event; No Apparent Adverse Event
PER THE CLINIC, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2025, IN ORDER TO REMOVE THE ABUTMENT ELECTIVELY AND DUE TO NON-USE. NO OTHER EVENT OR COMPLICATIONS THAT MAY HAVE CONTRIBUTED TO THE REMOVAL WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23778815 ↗InjuryDec 11, 2025No Apparent Adverse Event; No Apparent Adverse Event
PER THE CLINIC, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2025, IN ORDER TO REMOVE THE ABUTMENT ELECTIVELY AND DUE TO NON-USE. NO OTHER EVENT OR COMPLICATIONS THAT MAY HAVE CONTRIBUTED TO THE REMOVAL WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23778810 ↗InjuryOct 28, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED RECURRENT INFECTIONS, MILD PURULENT DRAINAGE AROUND IMPLANT SITE AND SKIN EDEMA. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS (SPECIFIC DATE NOT REPORTED) FOR 5 DAYS. THE IMPLANTED DEVICE REMAINS.
Patient problems: Purulent Discharge; Skin Infection; Swelling/ Edema
MAUDE report 23400477 ↗InjuryOct 28, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED RECURRENT INFECTIONS, MILD PURULENT DRAINAGE AROUND IMPLANT SITE AND SKIN EDEMA. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS (SPECIFIC DATE NOT REPORTED) FOR 5 DAYS. THE IMPLANTED DEVICE REMAINS.
Patient problems: Purulent Discharge; Skin Infection; Swelling/ Edema
MAUDE report 23400476 ↗InjurySep 4, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2025, AND THE SOFT TISSUES WERE REVISED. THE PATIENT ALSO UNDERWENT ABUTMENT REMOVAL AND REPLACEMENT WITH A NEW ABUTMENT DURING THE SAME SURGERY. THE IMPLANTED DEVICE REMAINS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22960461 ↗InjurySep 4, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2025, AND THE SOFT TISSUES WERE REVISED. THE PATIENT ALSO UNDERWENT ABUTMENT REMOVAL AND REPLACEMENT WITH A NEW ABUTMENT DURING THE SAME SURGERY. THE IMPLANTED DEVICE REMAINS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22960453 ↗
Other Hearing aid, bone conduction, implanted devices
- Baha 93331Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction, implanted446 reports
- Baha 93332Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction, implanted376 reports
- Baha 93550Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction, implanted371 reports
- Baha 93338Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction, implanted128 reports
- Ponto M52169Oticon Medical AB · Hearing Aid, Bone Conduction, Implanted124 reports
- Ponto M52170Oticon Medical AB · Hearing Aid, Bone Conduction, Implanted120 reports
- Baha 93335Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction, implanted81 reports
- Baha 93334Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction, implanted61 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.