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Sonify Hearing
Novidan, Inc. · Model 99-0014-01 · UDI-DI 00850049194075
0
510(k) clearances
13
Adverse events
1
Recalls
92
Facilities
Description
Hearing Aid, Air-Conduction with Wireless Technology, OTC, Mach I Pro W OTC Hearing Aids - Beige, pair, 312 battery
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 "Man |
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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.