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The Tracker / July 2026 / K254044

510(k) cleared

Hearing assist

Meta Platform Technologies, LLC · Jul 13, 2026 · K254044

FDA cleared the Hearing assist from Meta Platform Technologies, LLC on Jul 13, 2026 under K254044, a traditional 510(k). The device falls under product code SCR, Air-Conduction Hearing Aid Software, regulated at 21 CFR 874.3335 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on Dec 17, 2025. The decision came 208 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Meta Platform Technologies, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254044?

K254044 is the FDA 510(k) for Hearing assist, submitted by Meta Platform Technologies, LLC. FDA's decision date was Jul 13, 2026, under product code SCR (Air-Conduction Hearing Aid Software).

Who makes the Hearing assist?

Meta Platform Technologies, LLC, based in Burlingame, CA, is the applicant of record for K254044.

How long did the K254044 review take?

FDA received the submission on Dec 17, 2025 and issued its decision on Jul 13, 2026, 208 days later.

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