Hearing assist— 510(k) K254044

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.

Clearance details

Applicant: Meta Platform Technologies, LLC
Product code: 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 ↗

Recent devices under product code SCR

K261187 — Hearing Aid Feature2026-07-31
K251208 — Tuned Self-Fitting Mobile App2025-09-26
K243150 — Nuance Audio Hearing Aid Software2025-01-31
DEN230081 — Hearing Aid Feature (HAF)2024-09-12

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