Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart D — Prosthetic Devices](/submissions/EN/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 874.3335](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/874.3335) → SCR — Air-Conduction Hearing Aid Software

# SCR · Air-Conduction Hearing Aid Software

_Ear, Nose, Throat · 21 CFR 874.3335 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/SCR

## Overview

- **Product Code:** SCR
- **Device Name:** Air-Conduction Hearing Aid Software
- **Regulation:** [21 CFR 874.3335](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/874.3335)
- **Device Class:** 2
- **Review Panel:** [Ear, Nose, Throat](/submissions/EN)

## 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.

## Classification Rationale

Class II (special controls). The device is subject to the general controls of the FD&C Act, including 21 CFR 800.30 (over-the-counter hearing aids) and 21 CFR 801.422 (prescription hearing aids) as applicable, and the identified special controls.

## 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:

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K251208](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/SCR/K251208.md) | Tuned Self-Fitting Mobile App | Tuned , Ltd. | Sep 26, 2025 | SESE |
| [K243150](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/SCR/K243150.md) | Nuance Audio Hearing Aid Software | Luxottica Group S.P.A. | Jan 31, 2025 | SESE |
| [DEN230081](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/SCR/DEN230081.md) | Hearing Aid Feature (HAF) | Apple, Inc. | Sep 12, 2024 | DENG |

## Top Applicants

- Apple, Inc. — 1 clearance
- Luxottica Group S.P.A. — 1 clearance
- Tuned , Ltd. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/SCR](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/SCR)

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