Skip to content

Baha 5 Sound Processor, Blonde 95201Recalls & reported problems

Cochlear Bone Anchored Solutions AB · Class 2

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 09321502028783), received between Jan 22, 2018 and Aug 26, 2019 — classified as 3 injuries.

1 other recall cover devices cleared under the same FDA submission (K142907); they may or may not involve this specific model.

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.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2
  • Appropriate Device Problem Term/Code Not Available1

Patient problems

  • Patient Problem/Medical Problem2
  • Swelling2
  • Pain1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PER THE CLINIC, THE PATIENT EXPERIENCED SKIN SWOLLEN OVER THE ABUTMENT. TREATMENT WITH STEROID INJECTIONS WERE SUCCESSFUL.

    Patient problems: Patient Problem/Medical Problem; Swelling

    MAUDE report 8933483 ↗
  • InjuryAug 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PER THE CLINIC, THE PATIENT EXPERIENCED SKIN SWOLLEN OVER THE ABUTMENT. TREATMENT WITH STEROID INJECTIONS WERE SUCCESSFUL.

    Patient problems: Patient Problem/Medical Problem; Swelling

    MAUDE report 8933455 ↗
  • InjuryJan 22, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED RETENTION ISSUES AND PAIN AT THE MAGNET SITE. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018 IN ORDER TO CONVERT THE PATIENT TO A PERCUTANEOUS BAHA IMPLANT SYSTEM. DURING THE PROCEDURE, THE INTERNAL MAGNET WAS REMOVED AND AN ABUTMENT WAS PLACED ON THE INTERNAL FIXTURE.

    Patient problems: Pain

    MAUDE report 7208833 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142907. One submission often covers many models, so check the product and lot details in each record.

  • Z-0792-2020 · Dec 18, 2018 · Terminated
    Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.)

Other Hearing aid, bone conduction devices

All Hearing aid, bone conduction devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.