FDA 510(k)

Sontro® OTC Hearing Aids (AI)

K-Number: K231550 · 2023-10-26

Decision Date2023-10-26

Product CodeQUH

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

Sontro® OTC Hearing Aids (AI) is a medical device manufactured by Soundwave Hearing, LLC. It received FDA 510(k) clearance on 2023-10-26 under approval number K231550. 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 Sontro® OTC Hearing Aids (AI)?

Sontro® OTC Hearing Aids (AI) is a medical device that received FDA 510(k) clearance on 2023-10-26. It is manufactured by Soundwave Hearing, LLC. The 510(k) number is K231550.

When was Sontro® OTC Hearing Aids (AI) approved by the FDA?

Sontro® OTC Hearing Aids (AI) received FDA 510(k) clearance on 2023-10-26, under approval number K231550.

What company makes Sontro® OTC Hearing Aids (AI)?

Sontro® OTC Hearing Aids (AI) is manufactured by Soundwave Hearing, LLC.

What is the FDA product code for Sontro® OTC Hearing Aids (AI)?

The FDA product code for Sontro® OTC Hearing Aids (AI) is QUH.

Related Devices (Code: QUH)

K221698Eargo 5 , Eargo 6Eargo, Inc. K221064Nuheara IQbuds 2 PRO Hearing AidNuheara Limited K221052Self-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 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.