Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart D — Prosthetic Devices](/submissions/EN/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 874.3300](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/874.3300) → LDG — Kit, Earmold, Impression

# LDG · Kit, Earmold, Impression

_Ear, Nose, Throat · 21 CFR 874.3300 · Class 1_

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

## Overview

- **Product Code:** LDG
- **Device Name:** Kit, Earmold, Impression
- **Regulation:** [21 CFR 874.3300](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/874.3300)
- **Device Class:** 1
- **Review Panel:** [Ear, Nose, Throat](/submissions/EN)

## Identification

An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.

## Classification Rationale

Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K823921](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LDG/K823921.md) | PHYSICIANS CHOICE SILICONE EAR PUTTY | Santa Barbara Medco, Inc. | Mar 28, 1983 | SESE |
| [K792428](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LDG/K792428.md) | COE-SIL | Coe Laboratories, Inc. | Jan 23, 1980 | SESE |

## Top Applicants

- Santa Barbara Medco, Inc. — 1 clearance
- Coe Laboratories, Inc. — 1 clearance

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

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