TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40

K961143 · Telex Communications, Inc. · ESD · May 7, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K961143
• Device Name: TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40
• Applicant: Telex Communications, Inc.
• Product Code: ESD · Ear, Nose, Throat
• Decision Date: May 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3300
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

to amplify and transmit sound to the ear.

Device Story

FM at-the-ear auditory trainer; amplifies and transmits sound to user ear. Features Adaptive Compression; True FM Override; two-channel switch-selectable receiver; user-replaceable channel crystals. Function switch allows hearing aid only, FM reception only, or combined modes. Operated by user; powered by standard 675 hearing aid battery. Includes volume, mode, channel, and audiological controls (output, gain, tone). Used in clinical or educational settings to assist hearing-impaired individuals by improving signal-to-noise ratio via FM transmission.

Clinical Evidence

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

Technological Characteristics

FM auditory trainer; standard hearing aid components; frequency response per S3.2-1987 ANSI standard; powered by 675 battery; includes Adaptive Compression and audiological controls (output, gain, tone).

Indications for Use

Indicated for individuals requiring sound amplification and transmission to the ear via an FM at-the-ear auditory trainer.

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

• Phonic Ear PE700 Free Ear Auditory Trainer
• AVR/Sonovation Extend Ear
• Telex Model TDR-7AA (K913495)

Submission Summary (Full Text)

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TELEX
Item B
Telex Communications, Inc.
MAY - 7 1996
K961143

# 510(K) SUMMARY

| Trade Name: | Telex Select 2-40 with Adaptive Compression® |
| --- | --- |
| Common Name: | FM at-the-ear Auditory Trainer |
| Classification Name: | Hearing Aid, Group and Auditory Trainer, 77EPF |
| Equivalent to: | Phonic Ear PE700 Free Ear Auditory Trainer, or AVR/Sonovation Extend Ear, or Telex Model TDR-7AA K913495 |

9600 Aldrich Avenue South
Minneapolis, Minnesota 55420 USA
Telephone [phone]
Fax [phone]

## Description:

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

Features: Adaptive Compression; True FM Override (patent pending); two channel switch selectable receiver (patent pending); user replaceable channel crystals (patent pending); function switch allows hearing aid only, FM reception only, or both;

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, Mode Switch, Channel Selector Switch, Audiological Controls (output, gain, and tone).

Power: Standard hearing aid battery (675)

Comparison to predicate device: identical to the Phonic Ear PE700, except for two channel switch selectable FM reception, user replaceable channel crystals, and an additional audiological control (gain).

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: 19 March, 1996