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FDA 510(k)

MDHearingAid app, MDHearingAid Smart hearing aids

K-Number: K220303 · 2022-08-04

ApplicantMdhearingaid
Decision Date2022-08-04
Product CodeQDD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MDHearingAid app, MDHearingAid Smart hearing aids is the device name listed in this FDA 510(k) record. The listed applicant is Mdhearingaid. It received FDA 510(k) clearance on 2022-08-04 under 510(k) number K220303. 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 MDHearingAid app, MDHearingAid Smart hearing aids?

MDHearingAid app, MDHearingAid Smart hearing aids is a medical device that received FDA 510(k) clearance on 2022-08-04. The listed applicant is Mdhearingaid. The 510(k) number is K220303.

When did MDHearingAid app, MDHearingAid Smart hearing aids receive FDA 510(k) clearance?

MDHearingAid app, MDHearingAid Smart hearing aids received FDA 510(k) clearance on 2022-08-04, under 510(k) number K220303.

Who is the listed applicant for MDHearingAid app, MDHearingAid Smart hearing aids?

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

What is the FDA product code for MDHearingAid app, MDHearingAid Smart hearing aids?

The FDA product code for MDHearingAid app, MDHearingAid Smart hearing aids 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.

NCT06560918Self-efficacy-based Auditory Rehabilitation With Over-the-Counter Hearing AidsCOMPLETEDNCT07255586Self-monitoring of Hearing Aids Using Artificial IntelligenceNOT_YET_RECRUITING

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 CorporationK220403Vibe SF Self-Fitting Hearing AidWsaud A/SK213424Jabra 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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