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 Code	ESD
Regulation Number	874.3300
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	60	60
Insufficient Information	8	8
Defective Device	7	8
Detachment of Device or Device Component	4	4
Break	3	3
Patient-Device Incompatibility	3	4
Therapeutic or Diagnostic Output Failure	3	6
Improper or Incorrect Procedure or Method	3	3
Noise, Audible	3	4
Output Problem	2	2
Patient Device Interaction Problem	2	2
Use of Device Problem	2	2
Moisture or Humidity Problem	2	2
Product Quality Problem	2	4
No Apparent Adverse Event	2	2
Appropriate Term/Code Not Available	2	2
Inadequate Instructions for Non-Healthcare Professional	1	1
Unexpected Shutdown	1	1
Application Program Problem	1	1
Material Integrity Problem	1	1
Charging Problem	1	1
Electromagnetic Compatibility Problem	1	1
Packaging Problem	1	1
Inadequacy of Device Shape and/or Size	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	15	18
Unspecified Ear or Labyrinth Problem	15	15
Foreign Body In Patient	9	9
Fluid Discharge	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Hearing Impairment	3	3
Insufficient Information	3	4
Skin Tears	3	3
Itching Sensation	2	2
Blister	2	2
Partial Hearing Loss	2	2
Hematoma	1	1
Perforation	1	1
Abrasion	1	1
Rupture	1	1
Skin Erosion	1	1
Viral Infection	1	1
Tinnitus	1	1
Eczema	1	1