UNITRON MODEL SOUND F/X +4

K964503 · Unitron Industries, Inc. · ESD · Nov 27, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K964503
• Device Name: UNITRON MODEL SOUND F/X +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/transmits sound via air conduction. Features two-channel compression circuitry; Class D circuitry for battery efficiency; telecoil with pre-amplifier. User-adjustable controls include cross-over frequency, low channel gain, and threshold knee point; volume control; microphone/telecoil/off switch. Powered by size 13 battery. Used by patients with hearing loss; adjustments performed by clinicians based on individual audiogram. Benefits include improved auditory perception through customized sound amplification.

Clinical Evidence

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

Technological Characteristics

Behind-the-ear form factor; Class D circuitry; two-channel compression; telecoil with pre-amplifier; size 13 battery power. Technical specifications comply with ANSI S3.22-1987.

Indications for Use

Indicated for individuals requiring sound amplification via air conduction to the ear, adjusted based on individual audiogram.

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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UNITRON
INDUSTRIES INC.
NOV 27 1996
K964503

# A Summary of Safety and Effectiveness Information

Name of Device: Unitron Industries, Sound F/X +4

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

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

Features:
- Three fitter controls - Cross over frequency, low channel gain, and threshold knee point.
- Two channel compression circuitry.
- Class D circuitry for excellent battery life.
- Telecoil with pre-amplifier.

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.

Fit: Hearing aid adjustment dictated by individual audiogram.

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

Power: Standard hearing aid battery - size 13.

A user's guide 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]