Home › Device types › LXB
Hearing Aid, Bone Conduction
FDA product code LXB · Class 2 · Ear, Nose, Throat
785
Registered devices
7,171
Adverse events
7
Recalls
53
510(k) clearances
Devices with this code
NA — BHM-Tech Produktionsgesellschaft m.b.H.contact mini — BHM-Tech Produktionsgesellschaft m.b.H.Ponto — Oticon Medical ABBaha sound processor Cleaning kit — Cochlear Bone Anchored Solutions ABAN-Evo1 — BHM-Tech Produktionsgesellschaft m.b.H.ADHEAR Audio Processor (701), Dove Silver, lock — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.Ponto — Oticon Medical ABBaha 5 Demo, Black — Cochlear Bone Anchored Solutions ABcontact mini — BHM-Tech Produktionsgesellschaft m.b.H.ADHEAR User Kit, Simply Black/beige — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.Cochlear™ Baha® 6 Max Sound Processor, Black — Cochlear Bone Anchored Solutions ABBaha 7 Sound Processor, Blonde — Cochlear Bone Anchored Solutions ABcontact — BHM-Tech Produktionsgesellschaft m.b.H.Cochlear Baha SounBand bilateral, Black — Cochlear Bone Anchored Solutions ABNA — BHM-Tech Produktionsgesellschaft m.b.H.Baha® Fitting Software 5.2 — Cochlear Bone Anchored Solutions ABPonto — Oticon Medical ABPonto — Oticon Medical ABcontact — BHM-Tech Produktionsgesellschaft m.b.H.Baha — Cochlear Bone Anchored Solutions ABBaha 5 SuperPower Earhook+ (Medium, Mocha) — Cochlear Bone Anchored Solutions ABPonto — Oticon Medical ABATTRACT™ — MEDTRONIC XOMED, INC.Abutment Cover SilverGray — Cochlear Bone Anchored Solutions AB
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-12-18 | Cochlear Americas Inc. | Product was packaged with the Incorrect tamper proof battery door. |
| 2014-04-09 | Cochlear Americas Inc. | Cochlear America is recalling Cochlear Baha Soft Tissue Gauge due to possible manufacturing imperfection in the smooth surface of the metal that could potential |
| 2012-02-02 | Sonitus Medical Inc. | Sonitas received reports of stress cracking on the SoundBite Microphone Tube. |
| 2012-02-02 | Sonitus Medical Inc. | Sonitas received reports of stress cracking on the SoundBite Microphone Tube. |
| 2012-02-02 | Sonitus Medical Inc. | Sonitas received reports of stress cracking on the SoundBite Microphone Tube. |
| 2012-02-02 | Sonitus Medical Inc. | Sonitas received reports of stress cracking on the SoundBite Microphone Tube. |
| 2012-02-02 | Sonitus Medical Inc. | Sonitas received reports of stress cracking on the SoundBite Microphone Tube. |
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