Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart D — Prosthetic Devices](/submissions/EN/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 874.3305](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/874.3305) → OSM — Hearing Aid, Air-Conduction With Wireless Technology, Prescription

# OSM · Hearing Aid, Air-Conduction With Wireless Technology, Prescription

_Ear, Nose, Throat · 21 CFR 874.3305 · Class 2_

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

## Overview

- **Product Code:** OSM
- **Device Name:** Hearing Aid, Air-Conduction With Wireless Technology, Prescription
- **Regulation:** [21 CFR 874.3305](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/874.3305)
- **Device Class:** 2
- **Review Panel:** [Ear, Nose, Throat](/submissions/EN)

## Identification

A wireless air-conduction hearing aid is a wearable sound-amplifying device, intended to compensate for impaired hearing that incorporates wireless technology in its programming or use. A wireless air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable.

## Classification Rationale

Class II (special controls). The special controls for this device are:

## Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, and thermal safety of the device;
(2) Performance testing must validate safety of exposure to non-ionizing radiation; and
(3) Performance data must validate wireless technology functions.
(c)
*Premarket notification.* The wireless air-conduction hearing aid is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.

The C4-PA hearing aid, as a wireless air-conduction hearing aid, is subject to the following special controls:

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN100025](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/OSM/DEN100025.md) | WIDEXLINK IN CLEAR SERIES HEARING AIDS | Office Research IN Clinical Amplifiction | Mar 31, 2011 | DENG |

## Top Applicants

- Office Research IN Clinical Amplifiction — 1 clearance

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

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