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Headband for BAHA

by Entific Medical Systems, Inc. 510(k)

Active United States

510(k) K002913

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK002913 Date17 Oct 2000ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LXB
Device Class
Class II
Regulation
21 CFR Part 874.3302
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

A headband for bone-anchored hearing aid (BAHA) is a device designed to secure a bone conduction hearing aid to the user's head. It functions as a mechanical support system to position and stabilize the hearing aid transducer against the skull for effective sound transmission via bone conduction.

This device is supplied as a reusable accessory intended for use in clinical or home settings with bone-anchored hearing aids. It is non-sterile, not MRI safety evaluated in the provided data, and subject to traditional 510(k) clearance under product code LXB for ear, nose, and throat devices, with authorization granted on October 17, 2000.

Other devices from Entific Medical Systems, Inc.

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the HEADBAND FOR BAHA used for?

    The HEADBAND FOR BAHA is used to secure and stabilize a bone conduction hearing aid transducer against the user's skull, enabling effective sound transmission via bone conduction by maintaining proper positioning of the device during use.

  • Is the HEADBAND FOR BAHA sterile or non-sterile, and is it intended for single-use or reuse?

    The HEADBAND FOR BAHA is supplied as a non-sterile, reusable accessory, meaning it is designed for multiple uses over time and does not require sterilization before each application in clinical or home settings.

  • What regulatory pathway was used for the HEADBAND FOR BAHA, and what is its product code?

    The HEADBAND FOR BAHA received traditional 510(k) clearance under product code LXB for ear, nose, and throat devices, with authorization granted on October 17, 2000, based on a determination of substantial equivalence to a legally marketed predicate device.