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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tympanic membrane direct contact hearing aid
Definition A tympanic membrane contact hearing aid is intended to compensate for impaired hearing by transmitting amplified sound by vibrating the tympanic membrane through a transducer that is in direct contact with the tympanic membrane.
Product CodePLK
Regulation Number 874.3315
Device Class 2


Premarket Reviews
ManufacturerDecision
EARLENS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2
Unspecified Infection 1 1
Perforation 1 1

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