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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device self-fitting air-conduction hearing aid, prescription
Definition A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. This is a prescription hearing aid.
Product CodeQDD
Regulation Number 874.3325
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSE CORPORATION
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1
GN HEARING A/S
  SUBSTANTIALLY EQUIVALENT 1
INTRICON CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KAZ USA, INC., A HELEN OF TROY COMPANY
  SUBSTANTIALLY EQUIVALENT 1
MDHEARINGAID
  SUBSTANTIALLY EQUIVALENT 1
WSAUD A/S
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 1 1

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