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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Wsaud A/S. It received FDA 510(k) clearance on 2024-02-09 under 510(k) 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. The listed applicant is Wsaud A/S. The 510(k) number is K233464.

When did WSA Self-Fitting Hearing Aid Gen 2 receive FDA 510(k) clearance?

WSA Self-Fitting Hearing Aid Gen 2 received FDA 510(k) clearance on 2024-02-09, under 510(k) number K233464.

Who is the listed applicant for WSA Self-Fitting Hearing Aid Gen 2?

The FDA 510(k) record lists Wsaud A/S as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07667140Standard Post Market Clinical Follow-up (PMCF) Study WSA 2026COMPLETEDNCT07690670WhatsApp AI Support vs Paper Support for First-Time Hearing Aid UsersRECRUITINGNCT05451628Anatomy-Based Fitting in Unexperienced Cochlear Implant UsersRECRUITINGNCT06309264Comparing Hearing Aid Fitting Methods in Blast-exposed VeteransRECRUITINGNCT07255586Self-monitoring of Hearing Aids Using Artificial IntelligenceNOT_YET_RECRUITINGNCT07691853Anatomy-Based Fitting in Bimodal Cochlear Implant UsersRECRUITING

Other records listing Wsaud A/S as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220403Vibe SF Self-Fitting Hearing Aid

Related Devices (Code: QUH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254108Jabra Enhance Select Self-fit (Jabra Enhance Select 550)GN Hearing A/SK233747Concha Sol Hearing Aids (CL-1001)Concha LabsK231550Sontro® OTC Hearing Aids (AI)Soundwave Hearing, LLCK221052Self-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.

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