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JIUYEE, Smart Bluetooth Hearing Aid (RIC)

Hunan JIUYEE Medical Technology Co., Ltd · Model REAL P1, Emerald Black · UDI-DI 06975925880010

QUGOSM Prescription
0
510(k) clearances
15
Adverse events
1
Recalls
90
Facilities

Description

The hearing aid consists of the host and its accessories. The host comprises of the microphone, signal processor, battery, shell and receiver, and accessories, including the earplugs, cerumen baffle, charging box and charging cable. After inspection and fitting, the hearing aids is applicable for patients with air conduction hearing loss.

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.