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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cochlear implant with combined electrical stimulation and acoustic amplification
Definition Intended to provide electric stimulation to the mid to high frequency region of the cochlea and acoustic amplification to the low frequency regions, for patients with residual low frequency hearing sensitivity.
Product CodePGQ
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
6 1 6 4 1 0

MDR Year MDR Reports MDR Events
2020 27 27
2021 28 28
2022 22 22
2023 27 27
2024 19 19
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 65 65
Adverse Event Without Identified Device or Use Problem 20 20
Output Problem 9 9
Insufficient Information 9 9
Therapeutic or Diagnostic Output Failure 8 8
Migration 4 4
Device Dislodged or Dislocated 4 4
Expulsion 3 3
Electrical Shorting 2 2
Positioning Failure 1 1
Low impedance 1 1
Patient-Device Incompatibility 1 1
Migration or Expulsion of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 65 65
No Clinical Signs, Symptoms or Conditions 13 13
Hearing Impairment 9 9
Insufficient Information 9 9
Patient Problem/Medical Problem 6 6
Unspecified Infection 6 6
Pain 4 4
Head Injury 3 3
Tinnitus 2 2
Discomfort 2 2
Skin Inflammation/ Irritation 2 2
Bacterial Infection 2 2
Tissue Breakdown 1 1
No Code Available 1 1
Implant Pain 1 1

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