WSA Self-Fitting Hearing Aid Gen 2
K-Number: K233464 · 2024-02-09
ApplicantWsaud A/S
Decision Date2024-02-09
Product CodeQUH
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
WSA Self-Fitting Hearing Aid Gen 2 is a medical device manufactured by Wsaud A/S. It received FDA 510(k) clearance on 2024-02-09 under approval number K233464. The device is classified under product code QUH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the WSA Self-Fitting Hearing Aid Gen 2?
WSA Self-Fitting Hearing Aid Gen 2 is a medical device that received FDA 510(k) clearance on 2024-02-09. It is manufactured by Wsaud A/S. The 510(k) number is K233464.
When was WSA Self-Fitting Hearing Aid Gen 2 approved by the FDA?
WSA Self-Fitting Hearing Aid Gen 2 received FDA 510(k) clearance on 2024-02-09, under approval number K233464.
What company makes WSA Self-Fitting Hearing Aid Gen 2?
WSA Self-Fitting Hearing Aid Gen 2 is manufactured by Wsaud A/S.
What is the FDA product code for WSA Self-Fitting Hearing Aid Gen 2?
The FDA product code for WSA Self-Fitting Hearing Aid Gen 2 is QUH.
Related Clinical Trials
Other Devices by Wsaud A/S
Related Devices (Code: QUH)
K221698Eargo 5 , Eargo 6Eargo, Inc.
K221064Nuheara IQbuds 2 PRO Hearing AidNuheara Limited
K231550Sontro® OTC Hearing Aids (AI)Soundwave Hearing, LLC
K221052Self-Fitting hearing aidsHuizhou Jinghao Medical Technology Co., Ltd.
K223848Intrisound Tuned Lumen® 155 Hearing AidsTuned , Ltd.
K230538All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing AidSonova AG
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.