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AcoSound

Hangzhou AcoSound Technology Co.,Ltd. · Model Leya-W- BTE-M · UDI-DI 06973375883124

QUG
0
510(k) clearances
12
Adverse events
1
Recalls
90
Facilities

Recalls

DateFirmReason
2025-04-25HANGZHOU 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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Data 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.