ACOSOUND Leya-W- BTE-MRecalls & reported problems
Hangzhou AcoSound Technology Co.,Ltd. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 06973375880000), received between Feb 10, 2025 and Feb 10, 2025 — classified as 1 malfunction.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Apr 25, 2025Class IIIOpen, Classified
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 "Manufactured by Hangzhou AcoSound." And the labeling has no statement of the place of business for the manufacturer. 2. Customer information: The customer "Blaid" information is not correctly marked; Blaid is not the manufacturer. 3. UDI Information: The UDI information is incomplete and without DI information and correct Pl information, not complied with UDI label requirements.
Z-1976-2025 · Root cause: Labeling design · Recall details · FDA record ↗
Most reported problems
Device problems
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 10, 2025No Apparent Adverse Event; No Apparent Adverse Event
OUR COMPANY MDSAP CERTIFICATION AUDIT FINDINGS:NO EVIDENCE SHOWS THAT THE PRODUCT LABEL INFORMATION WITHOUT CORRECT UNIQUE DEVICE IDENTIFIER INFORMATION AND NOT COMPLIED UDI REQUIREMENTS, WITHOUT EXPIRATION DATE & PLACE OF BUSINESS INFORMATION, WITHOUT CORRECT MANUFACTURE INFORMATION (INFORMATION ON LABEL SUCH AS DEVELOPED BY ACOSOUND (MANUFACTURER), CUSTOMER BLAIDS (NOT MANUFACTURER) INFORMATION ON THE LABEL NOT CORRECT MARKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21351697 ↗
Other Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter devices
- GN Hearing 23685474Gn Hearing A/S · Hearing Aid, Air-Conduction with Wireless Technology, Over the Counter2 reports
- GN Hearing 23685475Gn Hearing A/S · Hearing Aid, Air-Conduction with Wireless Technology, Over the Counter2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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