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Device self-fitting air-conduction hearing aid, over the counter
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 an over the counter hearing aid. For information on the final rule “Establishing Over-the-Counter Hearing Aids,” please see 87 FR 50698, available at https://www.govinfo.gov/content/pkg/FR-2022-08-17/pdf/2022-17230.pdf.
Product CodeQUH
Regulation Number 874.3325
Device Class 2


Premarket Reviews
ManufacturerDecision
CONCHA LABS
  SUBSTANTIALLY EQUIVALENT 1
EARGO, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEARX SA (PTY) LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUIZHOU JINGHAO MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NUHEARA LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SONOVA AG
  SUBSTANTIALLY EQUIVALENT 1
SOUNDWAVE HEARING, LLC
  SUBSTANTIALLY EQUIVALENT 1
TUNED LTD
  SUBSTANTIALLY EQUIVALENT 1
WSAUD A/S
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 1 1
Degraded 1 1
Device Emits Odor 1 1
Device Markings/Labelling Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Ear or Labyrinth Problem 2 2
Itching Sensation 1 1
Foreign Body In Patient 1 1
Total Hearing Loss 1 1

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