Who is the manufacturer of UNITRON MODEL ICON AOHP +4 (ICON AOHP +4)?

Unitron Industries, Inc. submitted the Traditional clearance for UNITRON MODEL ICON AOHP +4 (ICON AOHP +4) (K964508).

What is the FDA product code for UNITRON MODEL ICON AOHP +4 (ICON AOHP +4)?

ESD. It is classified under 21 CFR 874.3300 as a Class 1 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for UNITRON MODEL ICON AOHP +4 (ICON AOHP +4)?

510(k) clearance (submission type: Traditional).

UNITRON MODEL ICON AOHP +4 (ICON AOHP +4)

K964508 · Unitron Industries, Inc. · ESD · Nov 27, 1996 · Ear, Nose, Throat

Device Facts

Record ID	K964508
Device Name	UNITRON MODEL ICON AOHP +4 (ICON AOHP +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 four fitter controls (power, compression limiting, active low cut tone, high cut tone); Class D circuitry for battery efficiency; telecoil with preamplifier. User-operated volume control and microphone/telecoil/off switch. Powered by size 13 battery. Assembled from standard industry components. Used by patients to improve hearing.

Clinical Evidence

Bench testing only; compliance with ANSI S3.22-1987 standard.

Technological Characteristics

Behind-the-ear form factor; Class D circuitry; telecoil with preamplifier; four fitter controls (power, compression, low/high cut tone); size 13 battery power; ANSI S3.22-1987 compliant.

Indications for Use

Indicated for individuals requiring sound amplification via air conduction to the ear.

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.

Related Devices

K964504 — UNITRON MODEL ICON AOHPL +4 · Unitron Industries, Inc. · Nov 27, 1996
K964510 — UNITRON MODEL ICON AOHPD +4 (ICON AOHPD +4) · Unitron Industries, Inc. · Nov 27, 1996
K960155 — UNITRON MODEL SOUND F/XP · Unitron Industries, Inc. · Mar 7, 1996
K964511 — UNITRON MODEL SOUND F/XD +4 (SOUND F/XD +4) · Unitron Industries, Inc. · Nov 27, 1996
K964502 — UNITRON MODEL SOUND F/XP +4 · Unitron Industries, Inc. · Nov 27, 1996

Submission Summary (Full Text)

{0} UNITRON INDUSTRIES INC. K964508 Nov. 27, 1996 # A Summary of Safety and Effectiveness Information Name of Device: Unitron Industries, ICON AoHP 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