Baha 93329Recalls & reported problems
Cochlear Bone Anchored Solutions AB · BIA400 Implant 4mm w Abutment 6mm · Class 2 · Implant
Quick summary
This Baha bone conduction implant with a short abutment is an implanted hearing aid that bypasses the outer ear. The 45 reports mostly describe redness, irritation and infection around the abutment site where the implant meets the skin, plus the bone not fusing with the implant, and some people needed antibiotics or revision surgery to lengthen or remove the abutment. All 45 reports involve injuries and no deaths. 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
- 45
- Deaths reported
- 0
- Injuries reported
- 45
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 09321502022699), received between Jul 28, 2017 and Jan 6, 2026 — classified as 45 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (15 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 Available18
- Patient Device Interaction Problem15
- Loss of Osseointegration11
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Skin Infection8
- No Code Available7
- Host-Tissue Reaction6
- Skin Inflammation/ Irritation6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available5
- Impaired Healing4
- Patient Problem/Medical Problem4
- Unspecified Infection3
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
InjuryJan 6, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED IRRITATION AT THE ABUTMENT SITE AND SUBSEQUENTLY, WAS TREATED WITH TOPICAL ANTIBIOTICS (DATE AND DURATION NOT REPORTED).
Patient problems: Skin Inflammation/ Irritation
MAUDE report 23971702 ↗InjuryJan 6, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED IRRITATION AT THE ABUTMENT SITE AND SUBSEQUENTLY, WAS TREATED WITH TOPICAL ANTIBIOTICS (DATE AND DURATION NOT REPORTED).
Patient problems: Skin Inflammation/ Irritation
MAUDE report 23971701 ↗InjuryAug 7, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL REVISION PROCEDURE ON (B)(6) 2025, UNDER GENERAL ANESTHESIA TO ADDRESS HYPERTROPHIC SCARRING AT THE ABUTMENT SITE WHICH LED TO THE DECISION TO CONVERT THE PATIENT TO A TRANSCUTANEOUS OSIA IMPLANT SYSTEM INCLUDING THE PLACEMENT OF A LONGER ABUTMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22734836 ↗InjuryAug 7, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL REVISION PROCEDURE ON (B)(6) 2025, UNDER GENERAL ANESTHESIA TO ADDRESS HYPERTROPHIC SCARRING AT THE ABUTMENT SITE WHICH LED TO THE DECISION TO CONVERT THE PATIENT TO A TRANSCUTANEOUS OSIA IMPLANT SYSTEM INCLUDING THE PLACEMENT OF A LONGER ABUTMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22734835 ↗InjuryNov 7, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED AN IRRITATION AND INFECTION AT THE ABUTMENT SITE (SPECIFIC DATE NOT REPORTED). SUBSEQUENTLY, THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2024, FOR A SKIN REVISION SURGERY. THE ABUTMENT WAS ALSO REMOVED DURING THE SAME SURGERY. THE IMPLANTED DEVICE REMAINS.
Patient problems: Skin Infection; Skin Inflammation/ Irritation
MAUDE report 20626966 ↗InjuryNov 7, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED AN IRRITATION AND INFECTION AT THE ABUTMENT SITE (SPECIFIC DATE NOT REPORTED). SUBSEQUENTLY, THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2024, FOR A SKIN REVISION SURGERY. THE ABUTMENT WAS ALSO REMOVED DURING THE SAME SURGERY. THE IMPLANTED DEVICE REMAINS.
Patient problems: Skin Infection; Skin Inflammation/ Irritation
MAUDE report 20626820 ↗InjuryAug 14, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AT THE IMPLANT SITE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Skin Infection
MAUDE report 19987747 ↗InjuryAug 14, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AT THE IMPLANT SITE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Skin Infection
MAUDE report 19987746 ↗InjuryJul 18, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2024, AND THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.
Patient problems: Skin Infection
MAUDE report 19769300 ↗InjuryJul 18, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE IMPLANT SITE (DATE 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 19769299 ↗InjuryJun 10, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2024 WHERE THE SURGEON HAD TO DRILL THE BONE THAT GREW OVER THE INTERNAL FIXTURE IN ORDER TO UNSCREW AND REMOVE THE ABUTMENT. THE INTERNAL FIXTURE REMAINS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19506830 ↗InjuryFeb 21, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH. SUBSEQUENTLY, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2019 IN ORDER TO EXPLANT THE DEVICE AND UNDERWENT A SKIN REVISION SURGERY TO REMOVE EXCESS SKIN. IT IS ALSO REPORTED THAT THE PATIENT WAS TREATED WITH TOPICAL AND ORAL ANTIBIOTICS (DATE AND DURATION NOT REPORTED).
Patient problems: Impaired Healing
MAUDE report 16406630 ↗InjuryFeb 21, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH. SUBSEQUENTLY, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2019 IN ORDER TO EXPLANT THE DEVICE AND UNDERWENT A SKIN REVISION SURGERY TO REMOVE EXCESS SKIN. IT IS ALSO REPORTED THAT THE PATIENT WAS TREATED WITH TOPICAL AND ORAL ANTIBIOTICS (DATE AND DURATION NOT REPORTED).
Patient problems: Impaired Healing
MAUDE report 16406620 ↗InjuryFeb 20, 2023Appropriate 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 POST IMPLANTATION (SPECIFIC DATE NOT REPORTED). 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 16403023 ↗InjuryFeb 20, 2023Appropriate 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 SKIN OVERGROWTH AROUND THE ABUTMENT SITE. THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE EXCESS SKIN ON (B)(6) 2023. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED) UNTIL INFECTION RESOLVED.
Patient problems: Impaired Healing; Skin Infection
MAUDE report 16402450 ↗InjuryMay 24, 2022Loss of Osseointegration; Loss of Osseointegration
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
MAUDE report 14483882 ↗InjuryMay 24, 2022Loss of Osseointegration; Loss of Osseointegration
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
MAUDE report 14483798 ↗InjuryApr 7, 2021Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE AUDIOLOGIST, IT WAS REPORTED THAT THE PATIENT EXPERIENCED SKIN OVERGROWTH, RESULTING IN THE DECISION TO UNDERGO A REVISION SURGERY ON (B)(6) 2021, 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.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11632176 ↗InjuryApr 7, 2021Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE AUDIOLOGIST, IT WAS REPORTED THAT THE PATIENT EXPERIENCED SKIN OVERGROWTH, RESULTING IN THE DECISION TO UNDERGO A REVISION SURGERY ON (B)(6) 2021, 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.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11632171 ↗InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN IRRITATION AT THE ABUTMENT SITE, AND WAS TREATED WITH TOPICAL ANTIBIOTICS FOR ONE WEEK IN MARCH, 2020 (SPECIFIC DATE NOT REPORTED). THE IMPLANTED DEVICE REMAINS.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 10519068 ↗InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN IRRITATION AT THE ABUTMENT SITE, AND WAS TREATED WITH TOPICAL ANTIBIOTICS FOR ONE WEEK IN (B)(6) 2020 (SPECIFIC DATE NOT REPORTED). THE IMPLANTED DEVICE REMAINS.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 10519065 ↗InjurySep 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AND SKIN OVERGROWTH AT THE ABUTMENT SITE. THE PATIENT UNDERWENT A PROCEDURE TO REMOVE THE SKIN AT THE INFECTED AREA, AND WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS.
Patient problems: Host-Tissue Reaction; Unspecified Infection
MAUDE report 10492325 ↗InjuryFeb 3, 2020Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION, SUBSEQUENTLY THE PATIENT WAS PLACED UNDER GENERAL ANAESTHETIC TO PLACE ABUTMENT ON SLEEPER IMPLANT.
Patient problems: No Code Available
MAUDE report 9662855 ↗InjuryFeb 3, 2020Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION, SUBSEQUENTLY THE PATIENT WAS PLACED UNDER GENERAL ANAESTHETIC TO PLACE ABUTMENT ON SLEEPER IMPLANT.
Patient problems: No Code Available
MAUDE report 9661852 ↗InjuryDec 9, 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 AND SUBSEQUENTLY WAS PLACED UNDER GENERAL ANAESTHESIA AND UNDERWENT SKIN REVISION SURGERY TO REPLACE ABUTMENT ON (B)(6) 2019. THE PATIENT WAS TREATED WITH INJECTABLE STEROIDS.
Patient problems: Host-Tissue Reaction
MAUDE report 9440540 ↗
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 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
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.