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Baha 5 SuperPower Earhook 2+ (XS)
Cochlear Bone Anchored Solutions AB · Model P1173605 · UDI-DI 09321502051408
LXB
Prescription
10
510(k) clearances
7,116
Adverse events (3 deaths)
7
Recalls
32
Facilities
Description
Retention device to hold Baha 5 SuperPower sound processor in Under-the-Ear position (UTE)
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 potentially leave residual me |
| 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.