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Second Ear Bone Conduction Hearing Aid

by Wordcomp International Communication Group (Wicg)

510(k) K953872

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK953872 Date12 Apr 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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, 21 Sep 2026

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

The Second Ear Bone Conduction Hearing Aid is a wearable sound-amplifying device designed to compensate for impaired hearing by bypassing outer and middle ear obstructions. It consists of a transducer unit, a pocket-sized audio processor/driver module, and a connecting cable. The device captures ambient sound via a built-in microphone in the processor module, processes the signal, and drives the transducer.

The device is supplied as a single unit, with a transducer held against the skull, and is intended for use in the ear, nose, and throat medical specialty. It has been cleared under FDA 510K, with a regulation number of 874.3302 and a product code of LXB. The device is manufactured by Wordcomp International Communication Group (Wicg) and has a registration number, with its authorisations including FDA 510K, and its decision description as Substantially Equivalent.

Questions

AI-generated answers, 21 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 Second Ear Bone Conduction Hearing Aid used for?

    The Second Ear Bone Conduction Hearing Aid is used to compensate for impaired hearing by bypassing outer and middle ear obstructions, and is intended for use in the ear, nose, and throat medical specialty.

  • How is the device supplied?

    The device is supplied as a single unit, consisting of a transducer unit, a pocket-sized audio processor/driver module, and a connecting cable.

  • Is the device cleared for use?

    Yes, the device has been cleared under FDA 510K, with a regulation number of 874.3302 and a product code of LXB, and is considered Substantially Equivalent.

  • What medical specialty is the device intended for?

    The device is intended for use in the ear, nose, and throat medical specialty.