TPLC - Total Product Life Cycle

• 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

MDR Year	MDR Reports	MDR Events
2015	3	3
2016	2	2
2017	1	1
2018	2	2
2019	14	14
2020	59	59
2021	16	16
2022	101	101
2023	158	158
2024	79	79

Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	165	165
Detachment of Device or Device Component	50	50
Patient Device Interaction Problem	50	50
Patient-Device Incompatibility	30	30
Adverse Event Without Identified Device or Use Problem	19	19
Product Quality Problem	14	14
Break	14	14
Insufficient Information	11	11
Temperature Problem	8	8
Biocompatibility	8	8
Fracture	7	7
Material Deformation	7	7
No Apparent Adverse Event	5	5
Device-Device Incompatibility	5	5
Material Fragmentation	5	5
Inadequacy of Device Shape and/or Size	5	5
Battery Problem	4	4
Mechanical Problem	4	4
Fire	3	3
Smoking	3	3
Human-Device Interface Problem	3	3
Material Integrity Problem	3	3
Appropriate Term/Code Not Available	3	3
Noise, Audible	2	2
Electrical Shorting	2	2
Output Problem	2	2
Unexpected Therapeutic Results	2	2
Improper or Incorrect Procedure or Method	2	2
Loss of or Failure to Bond	2	2
Off-Label Use	2	2
Crack	2	2
Material Discolored	1	1
Material Disintegration	1	1
Entrapment of Device	1	1
Burst Container or Vessel	1	1
Failure to Charge	1	1
Computer Software Problem	1	1
Contamination	1	1
Corroded	1	1
Melted	1	1
Fluid/Blood Leak	1	1
Leak/Splash	1	1
Charging Problem	1	1
Contamination /Decontamination Problem	1	1
Material Separation	1	1
Application Program Problem	1	1
Fitting Problem	1	1
Defective Component	1	1
Device Issue	1	1
Defective Device	1	1
Use of Device Problem	1	1
Physical Property Issue	1	1
Positioning Problem	1	1
Power Problem	1	1
Flare or Flash	1	1
Device Contamination with Chemical or Other Material	1	1
Therapeutic or Diagnostic Output Failure	1	1
Misassembly by Users	1	1
Device Difficult to Maintain	1	1
Wireless Communication Problem	1	1
Unintended Electrical Shock	1	1
Intermittent Energy Output	1	1
Excessive Heating	1	1
Separation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	251	251
Skin Irritation	36	36
Partial Hearing Loss	25	25
Hearing Impairment	21	21
Skin Inflammation/ Irritation	18	18
Hypersensitivity/Allergic reaction	11	11
Unspecified Infection	11	11
Foreign Body In Patient	9	9
Discomfort	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Local Reaction	7	7
Tinnitus	6	6
Patient Problem/Medical Problem	6	6
Unspecified Ear or Labyrinth Problem	6	6
Device Embedded In Tissue or Plaque	5	5
Burning Sensation	5	5
Hemorrhage/Bleeding	5	5
Skin Discoloration	5	5
Itching Sensation	5	5
Abrasion	5	5
Acoustic Trauma	4	4
Pain	4	4
Dizziness	4	4
Wheal(s)	4	4
Localized Skin Lesion	4	4
Skin Infection	4	4
Swelling/ Edema	3	3
No Known Impact Or Consequence To Patient	3	3
Fungal Infection	3	3
Superficial (First Degree) Burn	3	3
Fluid Discharge	3	3
Perforation	3	3
Inflammation	3	3
Irritation	3	3
Erythema	3	3
Acoustic Shock	2	2
Laceration(s)	2	2
Rash	2	2
No Consequences Or Impact To Patient	2	2
Diaphoresis	2	2
Insufficient Information	2	2
Skin Burning Sensation	2	2
Contact Dermatitis	1	1
Eczema	1	1
Skin Tears	1	1
Electric Shock	1	1
Tissue Breakdown	1	1
Neck Pain	1	1
Blister	1	1
No Code Available	1	1
Neuralgia	1	1
Epistaxis	1	1
Rupture	1	1
Pressure Sores	1	1
Vertigo	1	1
Sepsis	1	1
Muscle Weakness	1	1
Myocardial Infarction	1	1
Undesired Nerve Stimulation	1	1
Low Blood Pressure/ Hypotension	1	1
Hearing Loss	1	1
Headache	1	1
Burn(s)	1	1
Cyst(s)	1	1
Dyspnea	1	1