FDA 510(k)

Intrisound Tuned Lumen® 155 Hearing Aids

K-Number: K223848 · 2023-09-08

Decision Date2023-09-08

Product CodeQUH

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

Intrisound Tuned Lumen® 155 Hearing Aids is a medical device manufactured by Tuned , Ltd.. It received FDA 510(k) clearance on 2023-09-08 under approval number K223848. 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 Intrisound Tuned Lumen® 155 Hearing Aids?

Intrisound Tuned Lumen® 155 Hearing Aids is a medical device that received FDA 510(k) clearance on 2023-09-08. It is manufactured by Tuned , Ltd.. The 510(k) number is K223848.

When was Intrisound Tuned Lumen® 155 Hearing Aids approved by the FDA?

Intrisound Tuned Lumen® 155 Hearing Aids received FDA 510(k) clearance on 2023-09-08, under approval number K223848.

What company makes Intrisound Tuned Lumen® 155 Hearing Aids?

Intrisound Tuned Lumen® 155 Hearing Aids is manufactured by Tuned , Ltd..

What is the FDA product code for Intrisound Tuned Lumen® 155 Hearing Aids?

The FDA product code for Intrisound Tuned Lumen® 155 Hearing Aids is QUH.

Other Devices by Tuned , Ltd.

K251208Tuned Self-Fitting Mobile App

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. K230538All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing AidSonova AG K223137Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie ApplicationHearx SA (Pty) , Ltd.

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.