TPLC - Total Product Life Cycle

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Device	hearing aid, air-conduction with wireless technology, prescription
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 a prescprition hearing aid.
Product Code	OSM
Regulation Number	874.3305
Device Class	2

Premarket Reviews
Manufacturer	Decision
OFFICE RESEARCH IN CLINICAL AMPLIFICTION
	GRANTED	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	167	167
Detachment of Device or Device Component	83	83
Patient Device Interaction Problem	56	56
Patient-Device Incompatibility	31	31
Product Quality Problem	31	31
Break	20	20
Adverse Event Without Identified Device or Use Problem	19	19
Insufficient Information	12	12
Fracture	11	11
Material Deformation	9	9
Temperature Problem	9	9
Biocompatibility	8	8
No Apparent Adverse Event	7	7
Device-Device Incompatibility	5	5
Inadequacy of Device Shape and/or Size	5	5
Material Fragmentation	5	5
Battery Problem	4	4
Mechanical Problem	4	4
Material Integrity Problem	3	3
Smoking	3	3
Human-Device Interface Problem	3	3
Appropriate Term/Code Not Available	3	3
Fire	3	3
Electrical Shorting	2	2
Improper or Incorrect Procedure or Method	2	2
Unexpected Therapeutic Results	2	2
Melted	2	2
Crack	2	2
Off-Label Use	2	2
Output Problem	2	2
Loss of or Failure to Bond	2	2
Noise, Audible	2	2
Fluid/Blood Leak	1	1
Entrapment of Device	1	1
Burst Container or Vessel	1	1
Unintended Electrical Shock	1	1
Physical Property Issue	1	1
Application Program Problem	1	1
Intermittent Energy Output	1	1
Device Difficult to Maintain	1	1
Flare or Flash	1	1
Use of Device Problem	1	1
Material Discolored	1	1
Misassembly by Users	1	1
Environmental Compatibility Problem	1	1
Power Problem	1	1
Excessive Heating	1	1
Computer Software Problem	1	1
Charging Problem	1	1
Positioning Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	285	285
Skin Irritation	36	36
Partial Hearing Loss	25	25
Hearing Impairment	23	23
Skin Inflammation/ Irritation	18	18
Foreign Body In Patient	18	18
Unspecified Infection	11	11
Hypersensitivity/Allergic reaction	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Discomfort	9	9
Unspecified Ear or Labyrinth Problem	8	8
Local Reaction	7	7
Patient Problem/Medical Problem	6	6
Tinnitus	6	6
Itching Sensation	6	6
Device Embedded In Tissue or Plaque	5	5
Hemorrhage/Bleeding	5	5
Pain	5	5
Abrasion	5	5
Skin Discoloration	5	5
Burning Sensation	5	5
Skin Infection	4	4
Wheal(s)	4	4
Acoustic Trauma	4	4
Dizziness	4	4
Inflammation	4	4
Localized Skin Lesion	4	4
Insufficient Information	4	4
Swelling/ Edema	3	3
Fluid Discharge	3	3
Laceration(s)	3	3
Erythema	3	3
Irritation	3	3
No Known Impact Or Consequence To Patient	3	3
Perforation	3	3
Fungal Infection	3	3
Electric Shock	3	3
Superficial (First Degree) Burn	3	3
Burn(s)	2	2
Rash	2	2
Blister	2	2
Vertigo	2	2
Acoustic Shock	2	2
Diaphoresis	2	2
No Consequences Or Impact To Patient	2	2
Skin Burning Sensation	2	2
Epistaxis	1	1
Skin Disorders	1	1
Neck Pain	1	1
Skin Erosion	1	1