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FDA 510(k)

Hearing assist

K-Number: K254044 · 2026-07-13

ApplicantMeta Platform Technologies, LLC
Decision Date2026-07-13
Product CodeSCR
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Hearing assist is the device name listed in this FDA 510(k) record. The listed applicant is Meta Platform Technologies, LLC. It received FDA 510(k) clearance on 2026-07-13 under 510(k) number K254044. The device is classified under product code SCR. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hearing assist?

Hearing assist is a medical device that received FDA 510(k) clearance on 2026-07-13. The listed applicant is Meta Platform Technologies, LLC. The 510(k) number is K254044.

When did Hearing assist receive FDA 510(k) clearance?

Hearing assist received FDA 510(k) clearance on 2026-07-13, under 510(k) number K254044.

Who is the listed applicant for Hearing assist?

The FDA 510(k) record lists Meta Platform Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hearing assist?

The FDA product code for Hearing assist is SCR.

Related Devices (Code: SCR)

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.

K251208Tuned Self-Fitting Mobile AppTuned , Ltd.K243150Nuance Audio Hearing Aid SoftwareLuxottica Group S.P.A.

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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