← Product Code [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD) · K963788 # PRIMOFOCUS COMPACT (K963788) _Oticon Corp. · ESD · Nov 27, 1996 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K963788 ## Device Facts - **Applicant:** Oticon Corp. - **Product Code:** [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD.md) - **Decision Date:** Nov 27, 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 deliver sound to the ear. ## Device Story PrimoFocus Compact BTE hearing aid; amplifies and delivers sound to ear. Device utilizes class D output amplifier; single band compression amplifier with dual time constants and variable compression threshold. Assembled from standard electronic components and custom microchip/hybrid. Operated by patient/user via manual controls for parameter adjustments. Powered by standard type 13 battery. Fitting based on individual audiometric and patient history data to determine frequency response, gain, and SSPL 90. Provides sound amplification to assist patients with hearing impairment. ## Clinical Evidence bench testing only ## Technological Characteristics BTE hearing aid; 47 dB HFA gain; class D output amplifier; single band compression amplifier; manual controls; type 13 battery power; technical specifications per 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} K963788 NOV 27 1996 oticon OTICON, INC. 29 Schoolhouse Road P.O. Box 6724 Somerset, NJ 08875-6724 Toll-Free 1-800-526-3921 FAX (908) 560-0029 This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990. # SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION NAME OF DEVICE: PrimoFocus Compact TYPE OF DEVICE: BTE Hearing Aid INTENDED USE: To amplify and deliver sound to the ear. FEATURES: 47 Db HFA gain, single band compression amplifier with dual time constants and variable compression threshold, utilizes class D output amplifier. ASSEMBLY: Assembled from standard electronic hearing aid components mounted together with a custom microchip/hybrid. TECHNICAL CHARACTERISTICS: Technical specifications are in accordance with ANSI Standards S3.22-1987 FITTING CRITERIA: Frequency response, compression threshold, gain and SSPL 90 is dictated by individual audiometric and patient history data. ADJUSTMENTS/ CONTROLS: All parameters are adjusted via manual controls. POWER SOURCE: Standard type 13 battery. A USER INSTRUCTIONAL BROCHURE AND ADJUSTMENT INSTRUCTIONS ARE SUPPLIED WITH EACH HEARING AID. --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K963788](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K963788) **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