UNITRON MODEL SOUND F/XD +4 (SOUND F/XD +4)

K964511 · Unitron Industries, Inc. · ESD · Nov 27, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K964511
• Device Name: UNITRON MODEL SOUND F/XD +4 (SOUND F/XD +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 hearing aid; amplifies and transmits sound via air conduction. Features: three fitter controls (cross over frequency, low channel gain, threshold knee point); two-channel compression circuitry; Class D circuitry; telecoil with pre-amplifier; directional microphone. Powered by size 13 battery. Operated by patient; adjustment performed by clinician based on individual audiogram. Output assists hearing-impaired users by improving sound perception.

Clinical Evidence

Bench testing only; technical specifications comply with ANSI Standard S 3.22-1987.

Technological Characteristics

Behind-the-ear form factor; Class D circuitry; two-channel compression; telecoil with pre-amplifier; directional microphone. Power: size 13 battery. Technical specifications comply with ANSI Standard S 3.22-1987.

Indications for Use

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

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.
K964511
NOV 27 1996

# A Summary of Safety and Effectiveness Information

Name of Device: Unitron Industries, Sound F/XD $^{+4}$

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.
- 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.

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]