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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)
2015 2016 2017 2018 2019 2020
4 10 11 4 3 0

Device Problems
Appropriate Term/Code Not Available 87
Insufficient Information 3
Migration or Expulsion of Device 2
Extrusion 2
Adverse Event Without Identified Device or Use Problem 2
Electrode 1
Receiver Stimulator Unit 1
Magnet 1
Total Device Problems 99

Recalls
Manufacturer Recall Class Date Posted
1 MED-EL Elektromedizinische Gereate, Gmbh II Aug-02-2019

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