FDA 510(k)

Bose SoundControl Hearing Aids

K-Number: K211008 · 2021-05-05

Decision Date2021-05-05

Product CodeQDD

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

Bose SoundControl Hearing Aids is the device name listed in this FDA 510(k) record. The listed applicant is Bose Corporation. It received FDA 510(k) clearance on 2021-05-05 under 510(k) number K211008. 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 Bose SoundControl Hearing Aids?

Bose SoundControl Hearing Aids is a medical device that received FDA 510(k) clearance on 2021-05-05. The listed applicant is Bose Corporation. The 510(k) number is K211008.

When did Bose SoundControl Hearing Aids receive FDA 510(k) clearance?

Bose SoundControl Hearing Aids received FDA 510(k) clearance on 2021-05-05, under 510(k) number K211008.

Who is the listed applicant for Bose SoundControl Hearing Aids?

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

What is the FDA product code for Bose SoundControl Hearing Aids?

The FDA product code for Bose SoundControl Hearing Aids is QDD.

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 Corporation K220403Vibe SF Self-Fitting Hearing AidWsaud A/S K220303MDHearingAid app, MDHearingAid Smart hearing aidsMdhearingaid K213424Jabra Enhance PlusGN Hearing A/S K212609BHA100 Series Braun Clear Hearing AidKaz USA, Inc., A Helen of Troy Company

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.