TPLC - Total Product Life Cycle

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Device	hearing aid, air-conduction, prescription
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	7	7
Therapeutic or Diagnostic Output Failure	6	6
Insufficient Information	5	5
Patient Device Interaction Problem	5	5
Patient-Device Incompatibility	5	5
Defective Device	4	4
Noise, Audible	3	3
Break	2	2
Product Quality Problem	2	2
Inadequacy of Device Shape and/or Size	1	1
Use of Device Problem	1	1
Application Program Problem	1	1
Device-Device Incompatibility	1	1
Electromagnetic Compatibility Problem	1	1
Inadequate Instructions for Non-Healthcare Professional	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Moisture or Humidity Problem	1	1
Output Problem	1	1
Unintended Electrical Shock	1	1
Unexpected Shutdown	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	8	8
Hearing Impairment	5	5
No Known Impact Or Consequence To Patient	3	3
Partial Hearing Loss	2	2
Skin Inflammation	2	2
Foreign Body In Patient	2	2
Insufficient Information	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Electric Shock	1	1
Abrasion	1	1
Headache	1	1
Unspecified Ear or Labyrinth Problem	1	1
Not Applicable	1	1
Hearing Loss	1	1
Failure of Implant	1	1
Unspecified Infection	1	1
Pain	1	1
Perforation	1	1
Shock	1	1
Tinnitus	1	1
Twitching	1	1
Viral Infection	1	1
Therapeutic Response, Decreased	1	1
Discomfort	1	1
Impaired Healing	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	GN Hearing A/S	II	Nov-27-2019