← Product Code [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD) · K964683 # DIGIFOCUS ITE (K964683) _Oticon, Inc. · ESD · Dec 12, 1996 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K964683 ## Device Facts - **Applicant:** Oticon, Inc. - **Product Code:** [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD.md) - **Decision Date:** Dec 12, 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 DigiFocus ITE (DFI) is an in-the-ear hearing aid; utilizes true digital signal processing (DSP) for sound amplification. Input: acoustic signals. Processing: seven-band frequency shaping; two-channel compression system (syllabic compression <1500 Hz; nonsyllabic compression >1500 Hz). Output: amplified sound delivered to ear. Operation: digitally programmed via OtiSet software on NOAH platform; powered by size 312 battery. Used by patients with hearing impairment; fitted by audiologists/hearing professionals based on audiometric data. Benefits: improved sound audibility and speech understanding. ## Clinical Evidence Bench testing only; technical specifications provided in accordance with ANSI S3.22-1987. ## Technological Characteristics Seven-band, two-channel digital signal processing (DSP) hearing instrument. Components: custom microchips on flexfilm. Power: size 312 battery. Technical specs: ANSI S3.22-1987. Fitting: digitally programmed via OtiSet software. ## 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} K964683 DEC 12 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 safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990. # SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION **NAME OF DEVICE:** DigiFocus ITE (DFI) **TYPE OF DEVICE:** In the Ear Hearing Aid **INTENDED USE:** To amplify and deliver sound to the ear **FEATURES:** DigiFocus is a seven band, two channel fully automatic hearing instrument which utilizes true digital signal processing (DSP). True DSP allows for precise, seven band frequency shaping and a unique and complex compression system utilizing syllabic compression in the lower frequency channel (below 1500 Hz) and nonsyllabic compression in the higher frequency channel (above 1500Hz). 42 dB HFA gain. **ASSEMBLY:** Assembled from standard electronic hearing aid components mounted together with custom microchips on flexfilm. **TECHNICAL CHARACTERISTICS:** Technical specifications are in accordance with ANSI Standards S3.22-1987. **FITTING CRITERIA:** Frequency response, compression threshold and ratio, gain and SSPL 90 is dictated by individual audiometric and patient history data. **ADJUSTMENTS/CONTROLS:** All parameters are digitally programmed via OtiSet software using the standard NOAH platform. The hearing aid may have an optional T-M switch. **POWER SOURCE:** Standard size 312 battery. A USER INSTRUCTIONAL BROCHURE, INCLUDING ANSI TECHNICAL DATA IS SUPPLIED WITH EACH HEARING AID. --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K964683](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K964683) **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