UNITRON MODEL ICON AOHPD +4 (ICON AOHPD +4)

K964510 · Unitron Industries, Inc. · ESD · Nov 27, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K964510
• Device Name: UNITRON MODEL ICON AOHPD +4 (ICON AOHPD +4)
• Applicant: Unitron Industries, Inc.
• Product Code: ESD · Ear, Nose, Throat
• Decision Date: Nov 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3300
• Device Class: Class 1
• 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 include four fitter controls (power, compression limiting, active low cut tone, high cut tone), Class D circuitry, telecoil with preamplifier, and directional microphone. Powered by standard size 13 battery. Operated by user via volume control and microphone/telecoil/off switch. Used by patients with hearing impairment to improve auditory perception.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

BTE form factor; Class D circuitry; telecoil with preamplifier; directional microphone; standard size 13 battery; volume control and mode switch; technical specifications comply with ANSI S3.22-1987.

Indications for Use

Indicated for individuals requiring sound amplification via air conduction to the ear to assist with hearing impairment.

Regulatory Classification

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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K964510

UNITRON

INDUSTRIES INC.

NOV 27 1996

# A Summary of Safety and Effectiveness Information

Name of Device: Unitron Industries, ICON AoHPD +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.
Directional microphone.

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 [phone] Fax [phone]