← Product Code [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD) · K970519 # UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE) (K970519) _Unitron Industries, Inc. · ESD · Apr 24, 1997 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K970519 ## Device Facts - **Applicant:** Unitron Industries, Inc. - **Product Code:** [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD.md) - **Decision Date:** Apr 24, 1997 - **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 In-the-ear programmable hearing aid; amplifies/transmits sound via air conduction. Features two-channel wide dynamic range compression (WDRC) circuitry; twin average compression detectors; Class D circuitry. Five programmable parameters: low-channel gain, high-channel gain, cross-over frequency, threshold kneepoint, power. Powered by standard hearing aid batteries (size 13, 312, or 10A). Operated by patient; adjustments performed by hearing healthcare professional. Output assists patient in hearing by compensating for hearing loss. ## Clinical Evidence Bench testing only; compliance with ANSI S3.22-1987 standard. ## Technological Characteristics In-the-ear form factor; Class D circuitry; two-channel WDRC; programmable parameters (gain, frequency, kneepoint). Power: size 13, 312, or 10A batteries. Compliance: ANSI S3.22-1987. ## 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} UNITRON INDUSTRIES INC. K970519 APR 24 1997 # A Summary of Safety and Effectiveness Information Name of Device: Unitron Industries, Sound F/X Programmable Type of Device: In-The-Ear Programmable Hearing Aid. Substantially equivalent to other In-The-Ear Programmable hearing aids. Intended Use: To amplify and transmit sound via air conduction to the ear. Features: Five programmable parameters: Low-channel Gain, High-channel Gain, Cross-over Frequency, Threshold Kneepoint, Power. Two channels with wide dynamic range compression circuitry independently adjustable for each channel. Twin average compression detectors. Class D circuitry for excellent battery life. 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. Controls: Volume Control, similar to other devices. Power: Standard hearing aid battery - size 13, 312 or 10A. A user's manual and other information is supplied with each hearing aid. 3555 Walnut Street • P.O. Box 5010 • Port 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/K970519](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K970519) **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