← Product Code [LXB](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LXB) · K002913

# HEADBAND FOR BAHA (K002913)

_Entific Medical Systems, Inc. · LXB · Oct 17, 2000 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LXB/K002913

## Device Facts

- **Applicant:** Entific Medical Systems, Inc.
- **Product Code:** [LXB](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LXB.md)
- **Decision Date:** Oct 17, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.3302
- **Device Class:** Class 2
- **Review Panel:** Ear, Nose, Throat

## Regulatory Identification

A bone-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing and that conducts sound to the inner ear through the skull. The non-implantable components of a bone-conduction hearing aid, such as the external sound processor, are subject to the requirements in § 801.422 of this chapter.

---

**Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LXB/K002913](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LXB/K002913)

**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