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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hearing aid, air-conduction with wireless technology, over the counter
Regulation Description Wireless air-conduction hearing aid.
Definition A wireless air-conduction hearing aid is a wearable sound-amplifying device, intended to compensate for impaired hearing that incorporates wireless technology in its programming or use. This is an over the counter hearing aid. For information on the final rule “Establishing Over-the-Counter Hearing Aids,” please see 87 FR 50698, available at https://www.govinfo.gov/content/pkg/FR-2022-08-17/pdf/2022-17230.pdf.
Product CodeQUG
Regulation Number 874.3305
Device Class 2

MDR Year MDR Reports MDR Events
2023 4 4
2024 2 2
2025 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Product Quality Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Charging Problem 1 1
Detachment of Device or Device Component 1 1
Overheating of Device 1 1
Use of Device Problem 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
Foreign Body In Patient 3 3
Hearing Impairment 1 1
Skin Inflammation/ Irritation 1 1
Burning Sensation 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 HANGZHOU ACOSOUND TECHNOLOGY CO., LTD. III Jun-13-2025
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