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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
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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4
Foreign Body In Patient 2 2
Skin Inflammation/ Irritation 1 1
Unspecified Tissue Injury 1 1

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