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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, prescription
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 a prescription hearing aid.
Product CodeESD
Regulation Number 874.3300
Device Class 1


Premarket Reviews
ManufacturerDecision
SONOVA AG
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 5 5
2021 4 4
2022 4 4
2023 8 8
2024 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 13 13
Insufficient Information 7 7
Therapeutic or Diagnostic Output Failure 4 4
Break 4 4
Patient-Device Incompatibility 3 3
Defective Device 3 3
Noise, Audible 3 3
Product Quality Problem 2 2
Moisture or Humidity Problem 2 2
Detachment of Device or Device Component 2 2
No Apparent Adverse Event 2 2
Unexpected Shutdown 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Application Program Problem 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Patient Device Interaction Problem 1 1
Electromagnetic Compatibility Problem 1 1
Output Problem 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9 9
Unspecified Ear or Labyrinth Problem 6 6
Foreign Body In Patient 5 5
Hearing Impairment 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Insufficient Information 2 2
Partial Hearing Loss 2 2
Viral Infection 1 1
Discomfort 1 1
Abrasion 1 1
Headache 1 1
Hearing Loss 1 1
Hematoma 1 1
Eczema 1 1
Pain 1 1
Perforation 1 1
Shock 1 1
Tinnitus 1 1
Twitching 1 1
No Known Impact Or Consequence To Patient 1 1
Not Applicable 1 1

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