← Product Code [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD) · K961143 # TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40 (K961143) _Telex Communications, Inc. · ESD · May 7, 1996 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K961143 ## Device Facts - **Applicant:** Telex Communications, Inc. - **Product Code:** [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD.md) - **Decision Date:** May 7, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 874.3300 - **Device Class:** Class 1 - **Review Panel:** Ear, Nose, Throat - **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). ## Regulatory 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](/device/K913495.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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 612-884-4051 Fax 612-884-0043 ## 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 (612) 884-4051 voice (612) 884-0043 fax Contact: Tom Scheller Prepared: 19 March, 1996 --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K961143](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K961143) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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