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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, over the counter
Regulation Description Air-conduction hearing aid.
Definition An air-conduction hearing aid is a wearable sound amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. 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 CodeQUF
Regulation Number 874.3300
Device Class 1

MDR Year MDR Reports MDR Events
2022 1 1
2023 7 7
2024 9 9
2025 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Loss of or Failure to Bond 3 3
Defective Device 1 1
Device-Device Incompatibility 1 1
Defective Component 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17 17
Insufficient Information 4 4
Inadequate Pain Relief 2 2
Pressure Sores 1 1
Discomfort 1 1
Skin Tears 1 1
Tissue Breakdown 1 1
Foreign Body In Patient 1 1
Burning Sensation 1 1
Headache 1 1

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