Cleared Traditional

K254044 - Hearing assist

K254044 is an FDA 510(k) clearance for Hearing assist, manufactured by Meta Platform Technologies, LLC. The device is a Class 2 Ear, Nose, Throat device with product code SCR cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K254044 · Meta Platform Technologies, LLC · Ear, Nose, Throat device
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Jul 2026
Decision
208d
Days
Class 2
Risk

K254044 is an FDA 510(k) clearance for the Hearing assist. Classified as Air-conduction Hearing Aid Software (product code SCR), Class II - Special Controls.

Submitted by Meta Platform Technologies, LLC (Burlingame, US). The FDA issued a Cleared decision on July 13, 2026 after a review of 208 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3335 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Meta Platform Technologies, LLC devices

FDA 510(k) Submission Details - K254044

510(k) Number K254044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2025
Decision Date July 13, 2026
Days to Decision 208 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 89d · This submission: 208d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

SCR Device Classification - Class 2, Special Controls

Product Code SCR Air-conduction Hearing Aid Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3335
Definition Air-conduction Hearing Aid Software Is A Device That Is Intended To Be Used With A Compatible Wearable Hardware Platform To Compensate For Impaired Hearing. The Software Also Allows For Customization To The User's Hearing Needs. Devices In This Classification Are Also Subject To The Requirements In § 800.30 Or § 801.422 Of This Chapter, As Applicable. This Classification Does Not Include Software That Is Used With Hardware As Part Of A Hearing-aid Device System Classified In Other Regulations, E.g., § 874.3300, § 874.3305, Or § 874.3325.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.