Home › Device types › LXB
Hearing Aid, Bone Conduction
FDA product code LXB · Class 2 · Ear, Nose, Throat
781
Registered devices
7,116
Adverse events
7
Recalls
52
510(k) clearances
Devices with this code
Baha 5 SuperPower Processing unit — Cochlear Bone Anchored Solutions ABCochlear Baha SoundBand unilateral, Lavender — Cochlear Bone Anchored Solutions ABATTRACT™ — MEDTRONIC XOMED, INC.Inner Case Baha 4/BP100 (Spare part) — Cochlear Bone Anchored Solutions ABPonto — Oticon Medical ABBaha 5 SuperPower Earhook+ (Large, Maize) — Cochlear Bone Anchored Solutions ABBP100 & Baha 4 Battery door Champagne blonde — Cochlear Bone Anchored Solutions ABNA — BHM-Tech Produktionsgesellschaft m.b.H.Baha — Cochlear Bone Anchored Solutions ABOtomag™ Monaural Softband — MEDTRONIC XOMED, INC.Baha® Fitting Software 5 — Cochlear Bone Anchored Solutions ABcontact mini — BHM-Tech Produktionsgesellschaft m.b.H.Otomag™ Alpha (M) Magnetic Implant — MEDTRONIC XOMED, INC.Baha — Cochlear Bone Anchored Solutions ABADHEAR Professional Kit, Test/brown — Med-El Elektromedizinische Geräte Gesellschaft m.b.H.Baha — Cochlear Bone Anchored Solutions ABBaha — Cochlear Bone Anchored Solutions ABOtomag™ Attract™ Magnetic Spacer — MEDTRONIC XOMED, INC.Baha — Cochlear Bone Anchored Solutions ABPonto — Oticon Medical ABNA — BHM-Tech Produktionsgesellschaft m.b.H.NA — BHM-Tech Produktionsgesellschaft m.b.H.Baha Softband bilateral, Brown — Cochlear Bone Anchored Solutions ABNA — BHM-Tech Produktionsgesellschaft m.b.H.
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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