Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart D — Prosthetic Devices](/submissions/EN/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 874.3300](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/874.3300) → LRB — Face Plate Hearing Aid # LRB · Face Plate Hearing Aid _Ear, Nose, Throat · 21 CFR 874.3300 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LRB ## Overview - **Product Code:** LRB - **Device Name:** Face Plate Hearing Aid - **Regulation:** [21 CFR 874.3300](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/874.3300) - **Device Class:** 1 - **Review Panel:** [Ear, Nose, Throat](/submissions/EN) ## 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. ## Classification Rationale Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9. ## Recent Cleared Devices (20 of 24) Showing 20 most recent of 24 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K974219](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LRB/K974219.md) | FACEPLATE ASSEMBLY | Finetone Hearing Instruments | Feb 20, 1998 | SESE | | [K961593](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LRB/K961593.md) | INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS | Segi Hearing Aid Co. | Nov 7, 1996 | SESE | | [K942722](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LRB/K942722.md) | MODULE PROGRAM | Electone, Inc. | Sep 6, 1994 | SESE | | [K942236](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LRB/K942236.md) | AUDINA PREWIRES (FACEPLATE HEARING AID SERIES) | Audina Hearing Instrument | Jun 17, 1994 | SESE | | [K935048](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LRB/K935048.md) | ARTISAN PROGRAMMER & HEARING AID | Telex Communications, Inc. | Feb 9, 1994 | SESE | | [K933046](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LRB/K933046.md) | SILVER L MODULE, ITE | Electone, Inc. | Aug 2, 1993 | SESE | | [K933045](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LRB/K933045.md) | SILVER RECHARGEABLE MODULE, ITE | Electone, Inc. | Aug 2, 1993 | SESE | | [K933044](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LRB/K933044.md) | SILVER LD MODULE, ITE | Electone, Inc. | Aug 2, 1993 | SESE | | [K933043](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LRB/K933043.md) | SILVER PPP MODULE, ITE | Electone, Inc. | Aug 2, 1993 | SESE | | [K933040](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LRB/K933040.md) | GOLD CD MODULE, ITE | Electone, Inc. | Aug 2, 1993 | SESE | | [K933039](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LRB/K933039.md) | GOLD L MODULE, ITE | Electone, Inc. | Aug 2, 1993 | SESE | | [K933038](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LRB/K933038.md) | GOLD AF MODULE, ITE | Electone, Inc. | Aug 2, 1993 | SESE | | [K933037](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LRB/K933037.md) | GOLD K AMP, ITE | Electone, Inc. | Aug 2, 1993 | SESE | | [K910901](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LRB/K910901.md) | FACEPLATE ITE HEARING AID MODEL 28A | Telex Communications, Inc. | May 30, 1991 | SESE | | [K910900](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LRB/K910900.md) | FACEPLATE ITE HEARING AID MODEL TCA | Telex Communications, Inc. | May 30, 1991 | SESE | | [K897023](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LRB/K897023.md) | OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID | Audina Hearing Instrument | Mar 16, 1990 | SESE | | [K896304](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LRB/K896304.md) | OLYMPIA FACEPLATE MODULE | Olympia Instruments, Inc. | Jan 26, 1990 | SESE | | [K873031](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LRB/K873031.md) | STARKEY MODEL P1 MODULE | Starkey Laboratories, Inc. | Feb 8, 1988 | SESE | | [K873300](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LRB/K873300.md) | SERVICE MASTER (IMPULSE) | Richards Medical Co., Inc. | Dec 8, 1987 | SESE | | [K872645](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LRB/K872645.md) | AIR CONDUCTION IN-THE-EAR HEARING AID UA/115/SCR | Richards Medical Co., Inc. | Dec 8, 1987 | SESE | ## Top Applicants - Electone, Inc. — 9 clearances - Telex Communications, Inc. — 3 clearances - Audina Hearing Instrument — 2 clearances - Maico Hearing Instruments, Inc. — 2 clearances - Richards Medical Co., Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LRB](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LRB) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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