Hearing Aid, Bone Conduction
FDA adverse event reports and recall history for hearing aid, bone conduction (product code LXB), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 7,092
- Deaths
- 3
- Injuries
- 6,972
- Malfunctions
- 41
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2014-06-02TerminatedProcess control
Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. For use with Baha Attract hearing system.
Cochlear America is recalling Cochlear Baha Soft Tissue Gauge due to possible manufacturing imperfection in the smooth surface of the metal that could potentially leave residual metal on the patient's skin.
- 2012-03-07TerminatedNonconforming Material/Component
SoundBite Hearing System; Microphone Tube Size 0. For use in patients with moderately severe, severe or profound sensorineural hearing loss in one ear and normal hearing in the other or patients with conductive hearing loss where the pure tone average bond-conduction hearing threshold is better than or equal to 25 dB HL. Sonitus Medical, San Mateo, CA.
Sonitas received reports of stress cracking on the SoundBite Microphone Tube.
- 2012-03-07TerminatedNonconforming Material/Component
SoundBite Hearing System; Microphone Tube Size 1. For use in patients with moderately severe, severe or profound sensorineural hearing loss in one ear and normal hearing in the other or patients with conductive hearing loss where the pure tone average bond-conduction hearing threshold is better than or equal to 25 dB HL. Sonitus Medical, San Mateo, CA.
Sonitas received reports of stress cracking on the SoundBite Microphone Tube.
- 2012-03-07TerminatedNonconforming Material/Component
SoundBite Hearing System; Microphone Tube Size 2. For use in patients with moderately severe, severe or profound sensorineural hearing loss in one ear and normal hearing in the other or patients with conductive hearing loss where the pure tone average bond-conduction hearing threshold is better than or equal to 25 dB HL. Sonitus Medical, San Mateo, CA.
Sonitas received reports of stress cracking on the SoundBite Microphone Tube.
- 2012-03-07TerminatedNonconforming Material/Component
SoundBite Hearing System; Microphone Tube Size 3. For use in patients with moderately severe, severe or profound sensorineural hearing loss in one ear and normal hearing in the other or patients with conductive hearing loss where the pure tone average bond-conduction hearing threshold is better than or equal to 25 dB HL. Sonitus Medical, San Mateo, CA.
Sonitas received reports of stress cracking on the SoundBite Microphone Tube.
- 2012-03-07TerminatedNonconforming Material/Component
SoundBite Hearing System; Microphone Tube Size 4. For use in patients with moderately severe, severe or profound sensorineural hearing loss in one ear and normal hearing in the other or patients with conductive hearing loss where the pure tone average bond-conduction hearing threshold is better than or equal to 25 dB HL. Sonitus Medical, San Mateo, CA.
Sonitas received reports of stress cracking on the SoundBite Microphone Tube.
- TerminatedPackaging process control
Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.)
Product was packaged with the Incorrect tamper proof battery door.
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