← Product Code [SCR](/productcode/SCR) · K254044

# Hearing assist (K254044)

_Meta Platform Technologies, LLC · SCR · Jul 13, 2026 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K254044

## Device Facts

- **Applicant:** Meta Platform Technologies, LLC
- **Product Code:** [SCR](/productcode/SCR.md)
- **Decision Date:** Jul 13, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.3335
- **Device Class:** Class 2
- **Review Panel:** Ear, Nose, Throat

## Regulatory Identification

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. The Hearing Aid Feature (HAF) is a software-only mobile medical application intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment, utilizing a self-fitting strategy adjusted by the user without the assistance of a hearing healthcare professional.

## Special Controls

In combination with the general controls of the FD&C Act, including 21 CFR 800.30 (over-thecounter hearing aids) and 21 CFR 801.422 (prescription hearing aids) as applicable, airconduction hearing aid software is subject to the following special controls:

---

**Source:** [https://fda.innolitics.com/device/K254044](https://fda.innolitics.com/device/K254044)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com