← Product Code [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD) · K964639 # TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II (K964639) _Telex Communications, Inc. · ESD · Jan 21, 1997 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K964639 ## Device Facts - **Applicant:** Telex Communications, Inc. - **Product Code:** [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD.md) - **Decision Date:** Jan 21, 1997 - **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 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. ## 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 - Telex Model 28A ([K922066](/device/K922066.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 JAN 21 1997 Item C K964639 9600 Aldrich Avenue South Minneapolis, Minnesota 55420 USA Telephone 612-884-4051 (612) 884-0043 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 (612) 884-4051 voice (612) 884-0043 fax Contact: Tom Scheller Prepared: 15 November, 1996 --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K964639](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K964639) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com