UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE)

K970519 · Unitron Industries, Inc. · ESD · Apr 24, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K970519
• Device Name: UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE)
• Applicant: Unitron Industries, Inc.
• Product Code: ESD · Ear, Nose, Throat
• Decision Date: Apr 24, 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

In-the-ear programmable hearing aid; amplifies/transmits sound via air conduction. Features two-channel wide dynamic range compression (WDRC) circuitry; twin average compression detectors; Class D circuitry. Five programmable parameters: low-channel gain, high-channel gain, cross-over frequency, threshold kneepoint, power. Powered by standard hearing aid batteries (size 13, 312, or 10A). Operated by patient; adjustments performed by hearing healthcare professional. Output assists patient in hearing by compensating for hearing loss.

Clinical Evidence

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

Technological Characteristics

In-the-ear form factor; Class D circuitry; two-channel WDRC; programmable parameters (gain, frequency, kneepoint). Power: size 13, 312, or 10A batteries. Compliance: ANSI S3.22-1987.

Indications for Use

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

{0}

UNITRON INDUSTRIES INC.
K970519

APR 24 1997

# A Summary of Safety and Effectiveness Information

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

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

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

Features: Five programmable parameters: Low-channel Gain, High-channel Gain, Cross-over Frequency, Threshold Kneepoint, Power.

Two channels with wide dynamic range compression circuitry independently adjustable for each channel.

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: Volume Control, similar to other devices.

Power: Standard hearing aid battery - size 13, 312 or 10A.

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]