← Product Code [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD) · K963122 # UNITRON MODEL ICON KR (K963122) _Unitron Industries, Inc. · ESD · Sep 6, 1996 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K963122 ## Device Facts - **Applicant:** Unitron Industries, Inc. - **Product Code:** [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD.md) - **Decision Date:** Sep 6, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 874.3300 - **Device Class:** Class 1 - **Review Panel:** Ear, Nose, Throat - **Attributes:** Therapeutic ## Intended Use To amplify and transmit sound via air conduction to the ear. ## Device Story Behind-the-ear hearing aid; amplifies and transmits sound via air conduction. Features K-Amp circuit with Wide Dynamic Range compression; Class D circuits for battery efficiency; telecoil with pre-amplifier. User-adjustable controls include Low Cut Tone, High Cut Tone, Threshold Knee-point, and volume. Powered by size 13 battery. Operated by patient; adjustment dictated by individual audiogram. Benefits include improved sound perception for hearing-impaired users. ## Clinical Evidence Bench testing only; technical specifications comply with ANSI Standard S 3.22-1987. ## Technological Characteristics Behind-the-ear form factor; K-Amp circuit with Wide Dynamic Range compression; Class D output stage; telecoil with pre-amplifier; size 13 battery power; ANSI S 3.22-1987 compliant. ## 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. ## 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} K963122 UNITRON INDUSTRIES INC. SEP - 6 1996 # A Summary of Safety and Effectiveness Information Name of Device: Unitron Industries, ICON KR Type of Device: Behind-the-ear hearing aid. Substantially equivalent to other behind-the-ear hearing aids Intended Use: To amplify and transmit sound via air conduction to the ear. Features: Three fitter controls - Low Cut Tone, High Cut Tone, Threshold Knee-point. K-Amp circuit with Wide Dynamic Range compression. Class D circuits for excellent battery life. Telecoil with pre-amplifier. 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 Fit: Hearing aid adjustment dictates by individual audiogram Controls: Volume control, similar to other devices. Switch for selecting microphone, telecoil and off. Power: Standard hearing aid battery - size 13. A user's guide and other information is supplied with each hearing aid. 3555 Walnut Street • P.O. Box 5010 • Post Huron, Michigan 48061-5010 • Telephone (810) 982-0166 1-800-521-5400 Fax (810) 987-2011 --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K963122](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K963122) **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