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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 CodeOSM
Regulation Number 874.3305
Device Class 2

MDR Year MDR Reports MDR Events
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
Patient Device Interaction Problem 50 50
Detachment of Device or Device Component 49 49
Patient-Device Incompatibility 30 30
Adverse Event Without Identified Device or Use Problem 19 19
Product Quality Problem 14 14
Break 12 12
Insufficient Information 11 11
Temperature Problem 8 8
Biocompatibility 8 8
Material Deformation 7 7
Fracture 7 7
Material Fragmentation 5 5
Device-Device Incompatibility 5 5
Inadequacy of Device Shape and/or Size 5 5
No Apparent Adverse Event 5 5
Mechanical Problem 4 4
Fire 3 3
Smoking 3 3
Battery Problem 3 3
Material Integrity Problem 3 3
Appropriate Term/Code Not Available 3 3
Noise, Audible 2 2
Human-Device Interface Problem 2 2
Output Problem 2 2
Electrical Shorting 2 2
Loss of or Failure to Bond 2 2
Unexpected Therapeutic Results 2 2
Crack 2 2
Material Discolored 1 1
Entrapment of Device 1 1
Fluid/Blood Leak 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
Leak/Splash 1 1
Material Separation 1 1
Off-Label Use 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Defective Component 1 1
Application Program Problem 1 1
Flare or Flash 1 1
Device Contamination with Chemical or Other Material 1 1
Charging Problem 1 1
Contamination /Decontamination Problem 1 1
Positioning Problem 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
Discomfort 8 8
Foreign Body In Patient 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Local Reaction 7 7
Tinnitus 6 6
Unspecified Ear or Labyrinth Problem 6 6
Device Embedded In Tissue or Plaque 5 5
Skin Discoloration 5 5
Hemorrhage/Bleeding 5 5
Itching Sensation 5 5
Abrasion 5 5
Acoustic Trauma 4 4
Pain 4 4
Wheal(s) 4 4
Burning Sensation 4 4
Dizziness 4 4
Localized Skin Lesion 4 4
Skin Infection 4 4
Patient Problem/Medical Problem 4 4
Superficial (First Degree) Burn 3 3
Fluid Discharge 3 3
Swelling/ Edema 3 3
Fungal Infection 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
Insufficient Information 2 2
No Known Impact Or Consequence To Patient 2 2
Diaphoresis 2 2
Skin Burning Sensation 2 2
Neuralgia 1 1
Epistaxis 1 1
Blister 1 1
Skin Tears 1 1
Electric Shock 1 1
Tissue Breakdown 1 1
Contact Dermatitis 1 1
Eczema 1 1
Vertigo 1 1
Sepsis 1 1
Neck Pain 1 1
Pressure Sores 1 1
No Consequences Or Impact To Patient 1 1
Rupture 1 1
Muscle Weakness 1 1
Myocardial Infarction 1 1
Undesired Nerve Stimulation 1 1
Low Blood Pressure/ Hypotension 1 1
Headache 1 1
Burn(s) 1 1
Cyst(s) 1 1
Dyspnea 1 1

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