UNITRON MODEL SOUND F/X CIC

K970692 · Unitron Industries, Inc. · ESD · May 8, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K970692
• Device Name: UNITRON MODEL SOUND F/X CIC
• Applicant: Unitron Industries, Inc.
• Product Code: ESD · Ear, Nose, Throat
• Decision Date: May 8, 1997
• 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

Completely-In-The-Canal (CIC) hearing aid; amplifies/transmits sound via air conduction. Features two-channel wide dynamic range compression; six adjustable parameters (Low/High-channel Gain, See-Saw, Cross Over Frequency, Threshold Knee-point, power); twin average compression detectors; Class D circuitry. Powered by size 10A or 5A battery. Operated by patient; volume adjusted via screw set control. Assembled from standard industry components. Benefits patient by improving auditory perception.

Clinical Evidence

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

Technological Characteristics

CIC form factor; Class D circuitry; two-channel wide dynamic range compression; six adjustable parameters; screw set volume control; powered by size 10A or 5A batteries. Technical specifications comply with ANSI S3.22-1987.

Indications for Use

Indicated for individuals requiring sound amplification via air conduction to the ear to address 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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UNITRON
INDUSTRIES INC.
MAY - 8 1997
R970692

# A Summary of Safety and Effectiveness Information

Name of Device: Unitron Industries, Sound F/X CIC

Type of Device: Completely-In-The-Canal Hearing Aid. Substantially equivalent to other Completely-In-The-Canal hearing aids.

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

Features: Two channel wide dynamic range compression.
Six adjustable parameters: Low-channel Gain, High-channel Gain, See-Saw, Cross Over Frequency, Threshold Knee-point and power.
Twin average compression detectors.
Class D Circuitry for excellent battery life.

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: Screw set Volume Control, similar to other CIC devices.

Power: Standard hearing aid battery - size 10A or 5A.
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]