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FDA 510(k)

Vibe SF Self-Fitting Hearing Aid

K-Number: K220403 · 2022-08-12

ApplicantWsaud A/S
Decision Date2022-08-12
Product CodeQDD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Vibe SF Self-Fitting Hearing Aid 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 2022-08-12 under 510(k) number K220403. The device is classified under product code QDD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vibe SF Self-Fitting Hearing Aid?

Vibe SF Self-Fitting Hearing Aid is a medical device that received FDA 510(k) clearance on 2022-08-12. The listed applicant is Wsaud A/S. The 510(k) number is K220403.

When did Vibe SF Self-Fitting Hearing Aid receive FDA 510(k) clearance?

Vibe SF Self-Fitting Hearing Aid received FDA 510(k) clearance on 2022-08-12, under 510(k) number K220403.

Who is the listed applicant for Vibe SF Self-Fitting Hearing Aid?

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 Vibe SF Self-Fitting Hearing Aid?

The FDA product code for Vibe SF Self-Fitting Hearing Aid is QDD.

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.

K233464WSA Self-Fitting Hearing Aid Gen 2

Related Devices (Code: QDD)

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.

K223911Lumen 155-SFIntricon CorporationK220303MDHearingAid app, MDHearingAid Smart hearing aidsMdhearingaidK213424Jabra Enhance PlusGN Hearing A/SK212609BHA100 Series Braun Clear Hearing AidKaz USA, Inc., A Helen of Troy CompanyK211008Bose SoundControl Hearing AidsBose Corporation

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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