Baha 92346Recalls & reported problems
Cochlear Bone Anchored Solutions AB · BIA300 implant 4mm w Abutment 9mm · Class 2 · Implant
Quick summary
This Cochlear Baha bone-anchored hearing aid implant fixes to the skull behind the ear, with an external abutment that passes through the skin. Most of the 47 reports describe skin problems around the abutment — overgrowth of skin or granulation tissue, swelling, and infection — along with the implant not fusing well with the bone, often leading to revision surgery to trim the skin, remove or replace the abutment, or reposition the implant. All 47 reports are injuries, with 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
- 49
- Deaths reported
- 0
- Injuries reported
- 49
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 09321502019767), received between Sep 25, 2017 and Sep 21, 2026 — classified as 49 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (16 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
- Loss of Osseointegration16
- Patient Device Interaction Problem15
- Appropriate Device Problem Term/Code Not Available12
- Adverse Event Without Identified Device or Use Problem2
- Failure to Osseointegrate2
- Insufficient Device Problem Information2
Patient problems
- Inadequate Osseointegration14
- Unspecified Infection9
- Impaired Healing7
- Skin Infection6
- No Code Available4
- Swelling/ Edema4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Bacterial Infection2
Recent adverse event reports
The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.
InjurySep 21, 2026Patient Device Interaction Problem
Per the clinic, the patient experienced persistent skin complications (raised skin with localized itching) at the abutment site and the patient was treated with topical antibiotics (specific date and duration not reported).
Patient problems: Itching Sensation; Swelling/ Edema
MAUDE report 50836314 ↗InjurySep 7, 2026Patient Device Interaction Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50657600 ↗InjuryAug 3, 2026Patient Device Interaction Problem
Per the clinic, the patient was experienced the raise of granulation tissue and the abutment was buried. Subsequently, on (b)(6) 2026; the patient underwent skin revision procedure to trim the granulation tissue and the abutment was replaced.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50111540 ↗InjuryApr 4, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH ON THE ABUTMENT. SUBSEQUENTLY, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2026, IN ORDER TO REPLACE THE ABUTMENT.
Patient problems: Impaired Healing
MAUDE report 24786605 ↗InjuryApr 4, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH ON THE ABUTMENT. SUBSEQUENTLY, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2026, IN ORDER TO REPLACE THE ABUTMENT.
Patient problems: Impaired Healing
MAUDE report 24786604 ↗InjuryJan 5, 2026Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH ON THE ABUTMENT AND SLIGHT PAIN ON PALPATION. TREATMENT WITH TOPICAL ANTIBIOTIC (SPECIFIC DATE AND DURATION NOT REPORTED) WAS UNSUCCESSFUL. ADDITIONALLY, THE PATIENT REQUESTED REPOSITIONING OF THE IMPLANT TO A LOWER LOCATION, AS THE ORIGINAL PLACEMENT INTERFERED WITH THE PATIENT'S HAIR. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY UNDER GENERAL ANESTHESIA ON (B)(6) 2025, FOR AN ABUTMENT REMOVAL. THE IMPLANT FIXTURE COULD NOT BE REMOVED DUE TO FIRM OSSEOINTEGRATION AND WAS THEREFORE LEFT IN SITU AND CAPPED WITH A CONICAL COVER SCREW. A NEW IMPLANT SITE WAS CREATED APPROXIMATELY 1 CM INFERIOR TO THE ORIGINAL LOCATION, WHERE A NEW IMPLANT FIXTURE AND ABUTMENT WERE PLACED.
Patient problems: Impaired Healing; Implant Pain
MAUDE report 23970773 ↗InjuryDec 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED SWELLING AROUND THE ABUTMENT. SUBSEQUENTLY, THE PATIENT UNDERWENT SKIN REVISION SURGERY TO REMOVE THE EXCESS SKIN ON (B)(6) 2025.
Patient problems: Swelling/ Edema
MAUDE report 23800522 ↗InjurySep 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AND SKIN OVERGROWTH AROUND ABUTMENT SITE. SUBSEQUENTLY, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2025 IN ORDER TO REMOVE THE ABUTMENT. REIMPLANTATION 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: Impaired Healing; Skin Infection
MAUDE report 23023258 ↗InjurySep 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AND SKIN OVERGROWTH AROUND ABUTMENT SITE. SUBSEQUENTLY, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2025 IN ORDER TO REMOVE THE ABUTMENT. REIMPLANTATION 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: Impaired Healing; Skin Infection
MAUDE report 23023257 ↗InjuryApr 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED NUMEROUS SKIN INFECTION AROUND THE ABUTMENT SITE (SPECIFIC 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 21906117 ↗InjuryApr 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED NUMEROUS SKIN INFECTION AROUND THE ABUTMENT SITE (SPECIFIC 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 21906115 ↗InjuryApr 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE ABUTMENT FELL OFF AND PATIENT EXPERIENCED A SKIN OVERGROWTH ON THE ABUTMENT SITE. SUBSEQUENTLY, THE PATIENT UNDERWENT ABUTMENT REPLACEMENT SURGERY ON (B)(6) 2025 UNDER GENERAL ANESTHESIA. THE IMPLANTED DEVICE REMAINS
Patient problems: Impaired Healing
MAUDE report 21863359 ↗InjuryApr 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE ABUTMENT FELL OFF AND THE PATIENT EXPERIENCED SKIN OVERGROWTH AT THE ABUTMENT SITE. SUBSEQUENTLY, THE PATIENT UNDERWENT AN ABUTMENT REPLACEMENT SURGERY ON (B)(6) 2025 UNDER GENERAL ANESTHESIA. THE IMPLANTED DEVICE REMAINS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21863358 ↗InjuryMar 15, 2024Loss of Osseointegration; Loss 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Inadequate Osseointegration
MAUDE report 18909853 ↗InjuryNov 20, 2023Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE ABUTMENT SITE AND WAS TREATED WITH ORAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED). SUBESEQUENTLY, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION (SPECIFIC DATE NOT REPORTED), RESULTING IN FIXTURE LOSS. REIMPLANTATION IS PLANNED BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT.
Patient problems: Inadequate Osseointegration; Skin Infection
MAUDE report 18168273 ↗InjuryNov 20, 2023Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT UNDERWENT SILVER NITRATE CAUTERIZATION (SPECIFIC DATE NOT REPORTED).
Patient problems: Inadequate Osseointegration; Skin Infection
MAUDE report 18168272 ↗InjuryNov 20, 2023Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED INFECTION AT THE IMPLANT SITE AND A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS. THE PATIENT 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: Inadequate Osseointegration; Unspecified Infection
MAUDE report 18167902 ↗InjuryNov 20, 2023Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT UNDERWENT SKIN REVISION SURGERY TO EXCISE THE EXCESS SKIN (SPECIFIC DATE NOT REPORTED).
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 18167901 ↗InjuryOct 6, 2023Loss of Osseointegration; Loss 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Inadequate Osseointegration
MAUDE report 17883785 ↗InjuryOct 6, 2023Failure to Osseointegrate; Failure to Osseointegrate
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. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Inadequate Osseointegration
MAUDE report 17883784 ↗InjuryApr 13, 2023Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION OF THE IMPLANT ON (B)(6) 2022. THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE.
Patient problems: Inadequate Osseointegration
MAUDE report 16740101 ↗InjuryMar 7, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT EXPERIENCED SWELLING AND GRANULATION AT THE IMPLANT SITE. SUBSEQUENTLY, THE PATIENT UNDERWENT A SKIN REVISION SURGERY UNDER GENERAL ANESTHESIA ON (B)(6) 2022, IN ORDER TO REMOVE GRANULATION TISSUE. THE IMPLANTED DEVICE REMAINS.
Patient problems: Swelling/ Edema
MAUDE report 16500478 ↗InjuryOct 6, 2022Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS (SPECIFIC DATE NOT REPORTED). RE-IMPLANTATION IS PLANNED, HOWEVER, THIS HAS NOT OCCURRED AS OF THE DATE OF THIS REPORT.
Patient problems: Inadequate Osseointegration
MAUDE report 15548977 ↗InjuryOct 6, 2022Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS (SPECIFIC DATE NOT REPORTED). RE-IMPLANTATION IS PLANNED, HOWEVER, THIS HAS NOT OCCURRED AS OF THE DATE OF THIS REPORT.
Patient problems: Inadequate Osseointegration
MAUDE report 15548974 ↗InjuryAug 29, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AT THE IMPLANT SITE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Patient problems: Unspecified Infection
MAUDE report 15317324 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.