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Audien Hearing
Budget Hearing Aids, LLC · Model Atom X · UDI-DI 00850065060880
0
510(k) clearances
12
Adverse events
1
Recalls
90
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-25 | HANGZHOU ACOSOUND TECHNOLOGY CO., LTD. | Three issues 1. Label error: The manufacturer information in the labeling is not correct, the manufacturer's name is mislabeled as "Developed by AcoSound," Correct should be "Manu |
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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.