Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart D — Prosthetic Devices](/submissions/EN/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 874.3330](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/874.3330) → KHL — Hearing Aid, Master

# KHL · Hearing Aid, Master

_Ear, Nose, Throat · 21 CFR 874.3330 · Class 2_

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

## Overview

- **Product Code:** KHL
- **Device Name:** Hearing Aid, Master
- **Regulation:** [21 CFR 874.3330](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/874.3330)
- **Device Class:** 2
- **Review Panel:** [Ear, Nose, Throat](/submissions/EN)

## Identification

A master hearing aid is an electronic device intended to simulate a hearing aid during audiometric testing. It has adjustable acoustic output levels, such as those for gain, output, and frequency response. The device is used to select and adjust a person's wearable hearing aid.

## Classification Rationale

Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

## Recent Cleared Devices (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K964080](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/KHL/K964080.md) | LORI HEARING AID SIMULATOR | Lori Medical Laboratories, Inc. | Jan 8, 1997 | SESE |
| [K911726](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/KHL/K911726.md) | PROGRAMMABLE AUDITORY COMPARATOR, MODIFICATION | Bausch & Lomb, Inc. | Oct 23, 1991 | SESE |
| [K894019](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/KHL/K894019.md) | RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE | Resound Corp. | Sep 21, 1989 | SESE |
| [K860171](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/KHL/K860171.md) | VOROBA PROGRAMMABLE AUDITORY COMPARATOR | Voroba Technologies Assoc. | May 2, 1986 | SESE |
| [K854126](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/KHL/K854126.md) | CRAIGWELL MASTER HEARING AID MHA | Craigwell Electronics, Ltd. | Jan 16, 1986 | SESE |
| [K802812](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/KHL/K802812.md) | RIONET HEARING AID | Kindel & Anderson | Nov 26, 1980 | SESE |
| [K790481](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/KHL/K790481.md) | MODEL FS1 | Starkey Laboratories, Inc. | Apr 3, 1979 | SESE |

## Top Applicants

- Bausch & Lomb, Inc. — 1 clearance
- Craigwell Electronics, Ltd. — 1 clearance
- Kindel & Anderson — 1 clearance
- Lori Medical Laboratories, Inc. — 1 clearance
- Resound Corp. — 1 clearance

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

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