TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II

K964639 · Telex Communications, Inc. · ESD · Jan 21, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K964639
• Device Name: TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II
• Applicant: Telex Communications, Inc.
• Product Code: ESD · Ear, Nose, Throat
• Decision Date: Jan 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3300
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

to amplify and transmit sound to the ear.

Device Story

In-the-ear (ITE) custom hearing aid; amplifies and transmits sound to ear. Features threshold compression and 2-band compression (AC+). Assembled from standard industry components. Operated by patient; provides adjustable gain and frequency response. Controls include volume, low/high band gain, crossover frequency, threshold, loudness boost, and low-cut switch. Powered by standard hearing aid batteries (13, 312, 10A, or 5A). Assists patients with hearing impairment by adjusting dynamic range via 2-band compression.

Clinical Evidence

Bench testing only; compliance with ANSI S3.2-1987 standards for frequency response and technical specifications.

Technological Characteristics

ITE custom form factor; standard hearing aid components; ANSI S3.2-1987 compliant. Power: 13, 312, 10A, or 5A batteries. Features 2-band dynamic range compression amplifier. Manual controls: volume, gain, crossover, threshold, loudness boost, low-cut switch.

Indications for Use

Indicated for individuals requiring sound amplification to compensate for hearing loss.

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.

Predicate Devices

• Telex Model 28A (K922066)

Submission Summary (Full Text)

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TELEX

JAN 21 1997

Item C

K964639

9600 Aldrich Avenue South

Minneapolis, Minnesota 55420 USA

Telephone [phone]

[phone] fax

510(K) SUMMARY

Trade Name: Telex In-the-Ear Custom Hearing Aid with Threshold Compression II

Common Name: Hearing Aid, ITE

Classification Name: Air Conduction Hearing Aid, 77ESD

Equivalent to: Telex Model 28A K922066

Description:

Intended use: to amplify and transmit sound to the ear.

Features: Threshold Compression, 2-band compression, AC+

Assembly: assembled from standard components that are widely used by other hearing aid manufacturers.

Technical characteristics: technical specifications comply with S3.2-1987 ANSI standards.

Fit: frequency response per S3.2-1987 ANSI standard as shown on specification filed with 510(k).

Controls: Volume control, Low Band Gain (optional), High Band Gain (optional), Crossover Frequency (optional), Threshold Control, Loudness Boost (optional), Set-screw Volume Control (optional), Low cut Switch (optional)

Power: Standard hearing aid battery (13, 312, 10A or 5A)

Comparison to predicate device: identical to the model 28A, except for different amplifier which incorporates dynamic range compression in two bands as an optional compensation strategy.

Submitted by:

Tom Scheller
Chief Engineer
Hearing Instruments Group
Telex Communications, Inc.
9600 Aldrich Ave S.
Minneapolis, MN 55420
[phone] voice
[phone] fax

Contact: Tom Scheller

Prepared: 15 November, 1996