← Product Code [LRB](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LRB) · K961593 # INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS (K961593) _Segi Hearing Aid Co. · LRB · Nov 7, 1996 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LRB/K961593 ## Device Facts - **Applicant:** Segi Hearing Aid Co. - **Product Code:** [LRB](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LRB.md) - **Decision Date:** Nov 7, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 874.3300 - **Device Class:** Class 1 - **Review Panel:** Ear, Nose, Throat - **Attributes:** Therapeutic ## Indications for Use The intended use of these models is to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for impaired hearing. ## Device Story Intrastar pre-wired faceplates function as components for in-the-ear hearing aids; device amplifies sound pressure waves; transmits signal to external ear via air conduction; compensates for hearing impairment; intended for use by patients with hearing loss; operated by hearing healthcare professionals during fitting/assembly; output provides amplified sound to assist patient communication and auditory perception. ## Clinical Evidence No clinical data; substantial equivalence based on bench testing and comparison of performance characteristics to predicate devices. ## Technological Characteristics In-the-ear hearing aid pre-wired faceplates; analog amplification circuitry; frequency range 200-8000 Hz; maximum SSPL90 124.8-133.2 dB; full-on gain 38.3-55.4 dB; battery current 0.74-1.37 mA. ## 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 - Resound In-The-Ear Hearing Enhancement System ([K884871](/device/K884871.md)) - PRIZM Hearing System ([K902846](/device/K902846.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} K961593 NOV - 7 1996 501(k) Summary Date: April 10, 1996 Submission contact person: Leo Weinberger, Esq. 24 Fifth Avenue, New York, N.Y. 10011 (212) 228-4404; Fax: (212) 598-0904 The following information is submitted for approval as required by Title 21, Code of Federal Regulations, Subchapter H-Medical Devices, Subpart E, Paragraph 807.81-Premarket Notification. Device names: Trade names: Intrastar pre-wired faceplate in-the-ear hearing aid models: SP-W "A1" SP-W "K1" SP-W "K4" "G1" "G3" Common name: hearing aid pre-wired faceplate Classification name: hearing aid Substantial equivalence: The functions and design of the above-named devices are substantially equivalent to existing conventional devices installed in in-the-ear hearing aids currently available through commercial distribution, such as: | 510(k) Number | Trade/Proprietary Name | Manufacturer | | --- | --- | --- | | K884871 | Resound In-The-Ear Hearing Enhancement System | Resound Corp. | | (Attachment 3) | | | | K902846 | PRIZM Hearing System | AudioScience, Inc. | | (Attachment 4) | | | Description: Descriptions of the device functions, scientific concepts, and physical and performance characteristics of the above-mentioned Intrastar models are set forth in Attachments 1 and 2. - 9 - {1} Use: Segi Hearing Aid Co. is introducing into commercial distribution the above-mentioned Intrastar models of in-the-ear hearing aid pre-wired faceplates. The intended use of these models is to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for impaired hearing. Their function and design are substantially equivalent to those installed in existing conventional in-the-ear hearing aids currently available through commercial distribution. Comparison of technological characteristics: | | Intrastar All models | Resound K884871 | AudioScience K902846 | | --- | --- | --- | --- | | Maximum SSPL90 | 124.8-133.2 dB | 114 dB SPL | 122 dB SPL | | HF Avg. | 119.6-126.4 dB | 112 dB SPL | 114 dB SPL | | Full on gain | 38.3-55.4 dB | 54 dB max | 54 dB | | Reference test gain | 38.3-49.4 dB | | 54 dB | | Frequency range | 200-8000 Hz | 200-7000 Hz | 100-6800 Hz | | THD 500 Hz | 1.6-5.2% | | <5% | | THD 800 Hz | 1.8-13.4% | | <5% | | THD 1600 Hz | 0.3-7.7% | | <5% | | Equivalent input noise | 19.0-29.4 dB | 28 dB SPL | 21-26 dB | | Battery current | 0.74-1.37 mA | 1.3 mA | 2.2 mA | - 10 - --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LRB/K961593](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LRB/K961593) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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