BahaRecalls & reported problems across all models
Cochlear Bone Anchored Solutions AB · 29 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2,358
- Deaths reported
- 0
- Injuries reported
- 2,356
- Recalls
- 0
We found 29 models of Baha by Cochlear Bone Anchored Solutions AB in the FDA's device registry (GUDID). Together they are named in 2,358 adverse event reports in the FDA's MAUDE database, received between Oct 30, 2016 and Sep 29, 2026 — classified as 2,356 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (634 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Baha problems
Device problems
- Appropriate Device Problem Term/Code Not Available1,030
- Patient Device Interaction Problem634
- Loss of Osseointegration368
- Adverse Event Without Identified Device or Use Problem234
- Insufficient Device Problem Information41
- Failure to Osseointegrate21
- Loosening of Implant Not Related to Bone-Ingrowth19
- Expulsion15
Patient problems
- Unspecified Infection355
- Skin Infection319
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available225
- Impaired Healing223
- Inadequate Osseointegration218
- Pain214
- No Code Available186
- Host-Tissue Reaction169
Baha models
29 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Baha 93331Hearing aid, bone conduction, implanted446 reports
- Baha 93332Hearing aid, bone conduction, implanted376 reports
- Baha 93550Hearing aid, bone conduction, implanted371 reports
- Baha 93330Hearing aid, bone conduction, implanted269 reports
- Baha 93338Hearing aid, bone conduction, implanted128 reports
- Baha 92129Hearing aid, bone conduction127 reports
- Baha 93335Hearing aid, bone conduction, implanted81 reports
- Baha 92128Hearing aid, bone conduction77 reports
- Baha 93334Hearing aid, bone conduction, implanted61 reports
- Baha 92127Hearing aid, bone conduction55 reports
- Baha 90434Hearing aid, bone conduction54 reports
- Baha 93336Hearing aid, bone conduction, implanted51 reports
- Baha 92346Hearing aid, bone conduction49 reports
- Baha 93329Hearing aid, bone conduction, implanted45 reports
- Baha 93337Hearing aid, bone conduction, implanted35 reports
- Baha 92126Hearing aid, bone conduction27 reports
- Baha 93357Hearing aid, bone conduction, implanted23 reports
- Baha 92133Hearing aid, bone conduction21 reports
- Baha 93333Hearing aid, bone conduction, implanted15 reports
- Baha 92132Hearing aid, bone conduction9 reports
- Baha 92130Hearing aid, bone conduction9 reports
- Baha 92131Hearing aid, bone conduction9 reports
- Baha 90480Hearing aid, bone conduction7 reports
- Baha 90430Hearing aid, bone conduction4 reports
- Baha 90432Hearing aid, bone conduction3 reports
- Baha 92136Hearing aid, bone conduction2 reports
- Baha 94125Hearing aid, bone conduction2 reports
- Baha 92141Hearing aid, bone conduction1 report
- Baha 92841Hearing aid, bone conduction1 report
Recent Baha adverse event reports
The 15 most recent reports across all models, 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 ↗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 22, 2026Adverse Event Without Identified Device or Use Problem
Per the clinic, the device was electively explanted on (b)(6) 2026, in order for the patient to upgrade to a newer technology. The patient was reimplanted with transcutaneous Osia Implant System.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849828 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
Per the clinic, the device was electively explanted on (b)(6) 2026, in order for the patient to upgrade to a newer technology. The patient was reimplanted with transcutaneous Osia Implant System.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849827 ↗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 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 ↗InjurySep 17, 2026Patient Device Interaction Problem
Per the clinic, the patient experienced pain, irritation, tenderness, drainage and an infection at the abutment site. Subsequently, the patient was treated with oral antibiotic (specific date and duration not reported) and the abutment was removed on (b)(6) 2026. During the removal, the skin at the abutment site was erythematous and edematous, and the patient was treated with topical antibiotic. There are plans to place a new abutment; however, this has not occurred as of the date of this report.
Patient problems: Erythema; Fluid Discharge; Pain; Skin Infection; Skin Inflammation/ Irritation; Swelling/ Edema
MAUDE report 50799387 ↗InjurySep 17, 2026Patient Device Interaction Problem
Per the clinic, the patient experienced pain, irritation, tenderness, drainage and an infection at the abutment site. Subsequently, the patient was treated with oral antibiotic (specific date and duration not reported) and the abutment was removed on (b)(6) 2026. During the removal, the skin at the abutment site was erythematous and edematous, and the patient was treated with topical antibiotic. There are plans to place a new abutment; however, this has not occurred as of the date of this report.
Patient problems: Erythema; Fluid Discharge; Pain; Skin Infection; Skin Inflammation/ Irritation; Swelling/ Edema
MAUDE report 50799386 ↗InjurySep 15, 2026Loss of Osseointegration; Expulsion
Per the clinic, the patient experienced partial implant extrusion following head trauma from a pillow, with subsequent infection and loss of osseointegration resulting in fixture loss. The patient was reimplanted with another device on (b)(6), 2026. Additional information has been requested but has not been made available as of the date of this report.
Patient problems: Inadequate Osseointegration; Skin Infection
MAUDE report 50774540 ↗InjurySep 15, 2026Loss of Osseointegration; Expulsion
Per the clinic, the patient experienced partial implant extrusion following head trauma from a pillow, with subsequent infection and loss of osseointegration resulting in fixture loss. The patient was reimplanted with another device on (b)(6) 2026. Additional information has been requested but has not been made available as of the date of this report.
Patient problems: Inadequate Osseointegration; Skin Infection
MAUDE report 50774538 ↗InjurySep 11, 2026Patient Device Interaction Problem
Per the clinic, the patient experienced skin overgrowth on the abutment. Subsequently, the patient was placed under general anesthesia on (b)(6) 2026, in order to replace the abutment to a much longer length. The internal fixture remains.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50728336 ↗InjurySep 11, 2026Patient Device Interaction Problem
Per the clinic, the patient experienced skin overgrowth on the abutment. Subsequently, the patient was placed under general anaesthesia on (b)(6) 2026, in order to replace the abutment to a much longer length. The internal fixture remains.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50728334 ↗
Other Cochlear Bone Anchored Solutions AB products
All Cochlear Bone Anchored Solutions AB devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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