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HEARIT

by Je Liss & Co., Inc.

510(k) K934805

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK934805 Date7 Feb 1994ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
LZI
Device Class
Class II
Regulation
21 CFR Part 874.3320
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.

HEARIT is a group hearing aid or group auditory trainer intended for use in communicating simultaneously with one or more listeners having hearing impairment. It is classified as a Class II medical device under regulation number 874.3320 and is associated with the product code LZI.

The device received FDA 510(k) clearance (K934805) on February 7, 1994, following a traditional review process. It was found substantially equivalent to a predicate device and is manufactured by Je Liss & Co., Inc. in Tucson, Arizona. The device is used in Ear, Nose, and Throat applications as indicated by the advisory committee designation.

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 HEARIT device intended for?

    HEARIT is intended for use in communicating simultaneously with one or more listeners having hearing impairment, functioning as a group hearing aid or group auditory trainer in Ear, Nose, and Throat applications.

  • How is the HEARIT device supplied and what is its regulatory classification?

    HEARIT is a Class II medical device regulated under 21 CFR 874.3320 with product code LZI, and it received FDA 510(k) clearance through a traditional review process based on substantial equivalence to a predicate device.

  • Who manufactures the HEARIT device and where is it produced?

    HEARIT is manufactured by Je Liss & Co., Inc. at their facility located at 5665 N. Camino Estrellas, Tucson, Arizona 85718, United States.