Hearing assist— 510(k) K254044

Name: FDA 510(k) clearance K254044
Creator: U.S. Food and Drug Administration
Published: 2026-07-13

Substantially Equivalent

Meta Platform Technologies, LLC

FDA 510(k) clearance K254044 for Hearing assist, Substantially Equivalent on 2026-07-13. Applicant: Meta Platform Technologies, LLC. Device class: 2.

Summary

Meta Platform Technologies' Hearing assist is filed under SCR, air-conduction hearing aid software. The name is generic, and the record doesn't name the hardware it works with.

Class II, 21 CFR 874.3335. Ear, Nose, and Throat is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Meta Platform Technologies filed from Burlingame, California. Review took 208 calendar days (December 17, 2025 to July 13, 2026).

Clearance details

Applicant: Meta Platform Technologies, LLC
Product code: Product code SCR
Device class: Class 2
Regulation: 21 CFR 874.3335
Advisory panel: Ear, Nose, Throat
Date received: 2025-12-17
Decision date: 2026-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlingame, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.