UNITRON MODEL SOUND F/XP

K960155 · Unitron Industries, Inc. · ESD · Mar 7, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K960155
• Device Name: UNITRON MODEL SOUND F/XP
• Applicant: Unitron Industries, Inc.
• Product Code: ESD · Ear, Nose, Throat
• Decision Date: Mar 7, 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: 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. Operated by patient; adjustment performed by clinician based on individual audiogram. Powered by size 13 battery. Provides sound amplification to assist hearing-impaired users.

Clinical Evidence

No clinical data provided; bench testing only per ANSI S3.22-1987.

Technological Characteristics

BTE form factor; Class D circuitry; two-channel compression; directional microphone; 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.
K 960155
MAR - 7 1996

# A Summary of Safety and Effectiveness Information

Name of Device: Unitron Industries, Sound F/XP

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.
- Direction 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]