← Product Code [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD) · K964504

# UNITRON MODEL ICON AOHPL +4 (K964504)

_Unitron Industries, Inc. · ESD · Nov 27, 1996 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K964504

## Device Facts

- **Applicant:** Unitron Industries, Inc.
- **Product Code:** [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD.md)
- **Decision Date:** Nov 27, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.3300
- **Device Class:** Class 1
- **Review Panel:** Ear, Nose, Throat
- **Attributes:** Therapeutic

## Intended Use

To amplify and transmit sound via air conduction to the ear.

## Device Story

Behind-the-ear (BTE) hearing aid; amplifies and transmits sound via air conduction. Features Class D circuitry for battery efficiency; includes power, compression limiting, active low-cut, and high-cut tone controls. Equipped with telecoil and preamplifier. Operated by user via volume control and microphone/telecoil/off switch. Powered by standard size 13 hearing aid battery. Used by patients with hearing loss to improve auditory perception.

## Clinical Evidence

No clinical data; bench testing only.

## Technological Characteristics

Behind-the-ear form factor; Class D circuitry; telecoil with preamplifier; standard size 13 battery; volume control; microphone/telecoil/off switch. Technical specifications comply with ANSI Standard S 3.22-1987.

## Regulatory Identification

An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.

## Submission Summary (Full Text)

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{0}

UNITRON
INDUSTRIES INC.
K964504
NOV 27 1996

# A Summary of Safety and Effectiveness Information

Name of Device: Unitron Industries, ICON AoHPL $^{+4}$

Type of Device: Behind-The-Ear Hearing Aids. Substantially equivalent to other behind-the-ear hearing aids.

Intended Use: To amplify and transmit sound via air conduction to the ear.

Features: Four fitter controls - Power, Compression Limiting, active low cut tone, high cut tone.
Class D circuitry for excellent battery life.
Powerful telecoil with preamplifier.

Assembly: Assembled from standard components that are used by Unitron and other hearing aid manufacturers.

Technical Characteristics: Technical specifications comply with ANSI Standard S 3.22-1987.

Controls: Volume control, similar to other devices.
Switch for selecting microphone, telecoil and off.

Power: Standard hearing aid battery - size 13.

A user's manual and other information is supplied with each hearing aid.

3555 Walnut Street • P.O. Box 5010 • Port Huron, Michigan 48061-5010 • Telephone (810) 982-0166 1-800-521-5400 Fax (810) 987-2011

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K964504](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K964504)

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