← Product Code [KHL](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/KHL) · K854126

# CRAIGWELL MASTER HEARING AID MHA (K854126)

_Craigwell Electronics, Ltd. · KHL · Jan 16, 1986 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/KHL/K854126

## Device Facts

- **Applicant:** Craigwell Electronics, Ltd.
- **Product Code:** [KHL](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/KHL.md)
- **Decision Date:** Jan 16, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.3330
- **Device Class:** Class 2
- **Review Panel:** Ear, Nose, Throat

## Regulatory 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.

## 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.

---

**Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/KHL/K854126](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/KHL/K854126)

**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