Baha 93332Recalls & reported problems
Cochlear Bone Anchored Solutions AB · BIA400 Implant 4mm w Abutment 12mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Baha hearing implant has 372 reports, all of them injury reports, and no deaths. Many describe infections at the skin and abutment site, skin overgrowth around the abutment, and the implant losing its bond with bone, sometimes leading to removal. No recalls name this device. Recent reports fell from 46 to 16 compared with the period before.
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
- 376
- Deaths reported
- 0
- Injuries reported
- 376
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 376 adverse event reports that list this exact device (DI 09321502022729), received between Aug 10, 2017 and Sep 22, 2026 — classified as 376 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (76 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 Available169
- Patient Device Interaction Problem76
- Loss of Osseointegration74
- Adverse Event Without Identified Device or Use Problem38
- Insufficient Device Problem Information12
- Loosening of Implant Not Related to Bone-Ingrowth10
- Failure to Osseointegrate3
- Osseointegration Problem2
Patient problems
- Unspecified Infection69
- Skin Infection58
- Inadequate Osseointegration53
- Host-Tissue Reaction43
- No Code Available34
- Pain31
- Bacterial Infection30
- Patient Problem/Medical Problem25
Recent adverse event reports
The 25 most recent of 376 reports, in the reporter's own words as published by the FDA.
InjurySep 22, 2026Loosening of Implant Not Related to Bone-Ingrowth
Per the clinic, the patient experienced a loss of fixture subsequent to sustaining a head trauma (specific date not reported). The patient was reimplanted with another device under local anesthesia on (b)(6) 2026.
Patient problems: Head Injury; Inadequate Osseointegration
MAUDE report 50851005 ↗InjurySep 22, 2026Loosening of Implant Not Related to Bone-Ingrowth
Per the clinic, the patient experienced a loss of fixture subsequent to sustaining a head trauma (specific date not reported). The patient was re-implanted with another device under local anesthesia on (b)(6) 2026.
Patient problems: Head Injury; Inadequate Osseointegration
MAUDE report 50851004 ↗InjurySep 17, 2026Patient Device Interaction Problem
Per the clinic, the patient experienced multiple irritations, inflammation and infections at implant site. Subsequently, the patient was treated with oral antibiotics (specific date and duration not reported). After a period of time, the patient experienced redness, swelling and pain around the abutment tissues and was prescribed with oral antibiotics (specific date and duration not reported). Then, skin revision surgery was done with chemical cautery under local anesthesia however, the issue did not resolve. Subsequently, the device was explanted on (b)(6) 2026. 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: Erythema; Skin Infection; Skin Inflammation/ Irritation; Swelling/ Edema
MAUDE report 50801403 ↗InjurySep 17, 2026Patient Device Interaction Problem
Per the clinic, the patient experienced multiple irritations, inflammation and infections at implant site. Subsequently, the patient was treated with oral antibiotics (specific date and duration not reported). After a period of time, the patient experienced redness, swelling and pain around the abutment tissues and was prescribed with oral antibiotics (specific date and duration not reported). Then, skin revision surgery was done with chemical cautery under local anesthesia however, the issue did not resolve. Subsequently, the device was explanted on (b)(6) 2026. 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: Erythema; Skin Infection; Skin Inflammation/ Irritation; Swelling/ Edema
MAUDE report 50801402 ↗InjuryApr 28, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A GRANULATION TISSUE AROUND THE ABUTMENT. SUBSEQUENTLY, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2026; IN ORDER TO REMOVE THE ABUTMENT AND REPLACED DURING THE SAME SURGERY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25010897 ↗InjuryApr 28, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A GRANULATION TISSUE AROUND THE ABUTMENT. SUBSEQUENTLY, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2026; IN ORDER TO REMOVE THE ABUTMENT AND REPLACED DURING THE SAME SURGERY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25010896 ↗InjuryApr 24, 2026Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT DEVELOPED PAIN, SWELLING, AND SKIN OVERGROWTH. THE PATIENT SUBSEQUENTLY UNDERWENT SKIN REVISION SURGERY UNDER MONITORED ANESTHESIA CARE ON (B)(6) 2024, FOR EXCISION OF A POSTAURICULAR HYPERTROPHIC SCAR.
Patient problems: Pain; Swelling/ Edema
MAUDE report 24975476 ↗InjuryApr 24, 2026Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT DEVELOPED PAIN, SWELLING, AND SKIN OVERGROWTH. THE PATIENT SUBSEQUENTLY UNDERWENT SKIN REVISION SURGERY UNDER MONITORED ANESTHESIA CARE ON (B)(6) 2024, FOR EXCISION OF A POSTAURICULAR HYPERTROPHIC SCAR.
Patient problems: Pain; Swelling/ Edema
MAUDE report 24975471 ↗InjuryApr 20, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION, AND NON-HEALING SKIN AND TISSUE AFTER A BAHA ABUTMENT REMOVAL. SUBSEQUENTLY, THE IMPLANT WAS EXPLANTED ON (B)(6) 2026. REIMPLANTATION IS PLANNED BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT.
Patient problems: Impaired Healing; Inflammation; Purulent Discharge; Skin Infection
MAUDE report 24933858 ↗InjuryApr 9, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE ABUTMENT SITE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Skin Infection
MAUDE report 24831160 ↗InjuryApr 9, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE ABUTMENT SITE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Skin Infection
MAUDE report 24831159 ↗InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem
PER THE CLINIC, IT WAS REPORTED THAT THE PATIENT UNDERWENT EXPLANTATION SURGERY UNDER GENERAL ANAESTHESIA (DATE NOT REPORTED) DUE TO OBSOLETE EXTERNAL. THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE (SPECIFIC DATE NOT REPORTED).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24542541 ↗InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem
PER THE CLINIC, IT WAS REPORTED THAT THE PATIENT UNDERWENT EXPLANTATION SURGERY UNDER GENERAL ANAESTHESIA (DATE NOT REPORTED) DUE TO OBSOLETE EXTERNAL. THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE (SPECIFIC DATE NOT REPORTED).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24542540 ↗InjuryFeb 26, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT IMPLANT SITE AND SUBSEQUENTLY THE DEVICE WAS EXPLANTED (SPECIFIC DATE NOT REPORTED). THE PATIENT WAS REIMPLANTED WITH TRANSCUTANEOUS OSIA IMPLANT SYSTEM ON (B)(6) 2025.
Patient problems: Skin Infection
MAUDE report 24451273 ↗InjuryFeb 26, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT IMPLANT SITE AND SUBSEQUENTLY THE DEVICE WAS EXPLANTED (SPECIFIC DATE NOT REPORTED). THE PATIENT WAS REIMPLANTED WITH TRANSCUTANEOUS OSIA IMPLANT SYSTEM ON (B)(6) 2025.
Patient problems: Skin Infection
MAUDE report 24451270 ↗InjuryJan 5, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A RECURRENT INFECTION AROUND THE ABUTMENT SITE (SPECIFIC DATE NOT REPORTED). THE PATIENT WAS TREATED WITH ANTIBIOTICS (SPECIFIC TYPE, DATE AND DURATION NOT REPORTED); HOWEVER, THE ISSUE DID NOT RESOLVED. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY UNDER GENERAL ANAESTHESIA ON (B)(6) 2025, IN ORDER TO TRANSITION THE PATIENT TO A TRANSCUTANEOUS OSIA IMPLANT SYSTEM. DURING THE PROCEDURE, THE ABUTMENT WAS REMOVED AND THE IMPLANT WAS PLACED ON A NEWLY IMPLANTED INTERNAL FIXTURE.
Patient problems: Skin Infection
MAUDE report 23970509 ↗InjuryDec 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AND ABCESS FORMED AT THE IMPLANT SITE. THE PATIENT WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED) HOWEVER THE ISSUE DID NOT RESOLVE. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2025 UNDER GENERAL ANESTHESIA. THE PATIENT WAS NOT REIMPLANTED.
Patient problems: Abscess; Skin Infection
MAUDE report 23764325 ↗InjuryDec 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AND ABCESS FORMED AT THE IMPLANT SITE. THE PATIENT WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED) HOWEVER THE ISSUE DID NOT RESOLVE. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2025 UNDER GENERAL ANESTHESIA. THE PATIENT WAS NOT REIMPLANTED.
Patient problems: Abscess; Skin Infection
MAUDE report 23764324 ↗InjuryNov 4, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE DEVICE WAS EXPLANTED (SPECIFIC DATE NOT REPORTED) DUE TO SKIN OVERGROWTH AND SOFT TISSUE COMPLICATION. THERE ARE PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE; HOWEVER, THIS HAS NOT OCCURRED AS OF THE DATE OF THIS REPORT.
Patient problems: Impaired Healing
MAUDE report 23472605 ↗InjuryNov 4, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE DEVICE WAS EXPLANTED (SPECIFIC DATE NOT REPORTED) DUE TO SKIN OVERGROWTH AND SOFT TISSUE COMPLICATION. THERE ARE PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE; HOWEVER, THIS HAS NOT OCCURRED AS OF THE DATE OF THIS REPORT.
Patient problems: Impaired Healing
MAUDE report 23472603 ↗InjurySep 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED INFECTION AT THE ABUTMENT SITE. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS (DATE AND DURATION NOT REPORTED). THE ABUTMENT WAS REMOVED ON (B)(6) 2025. THE PATIENT WAS REIMPLANTED WITH A TRANSCUTANEOUS OSIA IMPLANT SYSTEM AT A NEW SITE.
Patient problems: Skin Infection
MAUDE report 23012889 ↗InjurySep 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED INFECTION AT THE ABUTMENT SITE. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS (DATE AND DURATION NOT REPORTED). THE ABUTMENT WAS REMOVED ON (B)(6) 2025. THE PATIENT WAS RE-IMPLANTED WITH A TRANSCUTANEOUS OSIA IMPLANT SYSTEM AT A NEW SITE.
Patient problems: Skin Infection
MAUDE report 23012888 ↗InjurySep 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED INFECTION AROUND THE ABUTMENT SITE. SUBSEQUENTLY, AN ABUTMENT REMOVAL PROCEDURE WAS DONE ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Skin Infection
MAUDE report 22948498 ↗InjurySep 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2025, IN ORDER TO REMOVE THE ABUTMENT.
Patient problems: Skin Infection
MAUDE report 22948497 ↗InjuryAug 21, 2025Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF FIXTURE. 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 22858113 ↗
Other Hearing aid, bone conduction, implanted devices
- Baha 93331Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction, implanted446 reports
- Baha 93550Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction, implanted371 reports
- Baha 93330Cochlear Bone Anchored Solutions AB · Hearing aid, bone conduction, implanted269 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 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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