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510(k) K220403

Vibe SF Self-Fitting Hearing Aid by Wsaud A/S — Product Code QDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2022
Date Received
February 11, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Self-Fitting Air-Conduction Hearing Aid, Prescription
Device Class
Class II
Regulation Number
874.3325
Review Panel
EN
Submission Type

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.

Other clearances by Wsaud A/S

  • K233464 — WSA Self-Fitting Hearing Aid Gen 2 (February 9, 2024)

Other clearances for product code QDD

  • K223911 — Lumen 155-SF (October 17, 2023)
  • K220303 — MDHearingAid app, MDHearingAid Smart hearing aids (August 4, 2022)
  • K213424 — Jabra Enhance Plus (January 19, 2022)
  • K212609 — BHA100 Series Braun Clear Hearing Aid (January 5, 2022)
  • K211008 — Bose SoundControl Hearing Aids (May 5, 2021)
  • DEN180026 — Bose Hearing Aid (October 5, 2018)