LRB · Face Plate Hearing Aid
Ear, Nose, Throat · 21 CFR 874.3300 · Class 1
Overview
| Product Code | LRB |
|---|---|
| Device Name | Face Plate Hearing Aid |
| Regulation | 21 CFR 874.3300 |
| Device Class | Class 1 |
| Review Panel | Ear, Nose, Throat |
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 | FACEPLATE ASSEMBLY | Finetone Hearing Instruments | Feb 20, 1998 | SESE |
| K961593 | INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS | Segi Hearing Aid Co. | Nov 7, 1996 | SESE |
| K942722 | MODULE PROGRAM | Electone, Inc. | Sep 6, 1994 | SESE |
| K942236 | AUDINA PREWIRES (FACEPLATE HEARING AID SERIES) | Audina Hearing Instrument | Jun 17, 1994 | SESE |
| K935048 | ARTISAN PROGRAMMER & HEARING AID | Telex Communications, Inc. | Feb 9, 1994 | SESE |
| K933046 | SILVER L MODULE, ITE | Electone, Inc. | Aug 2, 1993 | SESE |
| K933045 | SILVER RECHARGEABLE MODULE, ITE | Electone, Inc. | Aug 2, 1993 | SESE |
| K933044 | SILVER LD MODULE, ITE | Electone, Inc. | Aug 2, 1993 | SESE |
| K933043 | SILVER PPP MODULE, ITE | Electone, Inc. | Aug 2, 1993 | SESE |
| K933040 | GOLD CD MODULE, ITE | Electone, Inc. | Aug 2, 1993 | SESE |
| K933039 | GOLD L MODULE, ITE | Electone, Inc. | Aug 2, 1993 | SESE |
| K933038 | GOLD AF MODULE, ITE | Electone, Inc. | Aug 2, 1993 | SESE |
| K933037 | GOLD K AMP, ITE | Electone, Inc. | Aug 2, 1993 | SESE |
| K910901 | FACEPLATE ITE HEARING AID MODEL 28A | Telex Communications, Inc. | May 30, 1991 | SESE |
| K910900 | FACEPLATE ITE HEARING AID MODEL TCA | Telex Communications, Inc. | May 30, 1991 | SESE |
| K897023 | OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID | Audina Hearing Instrument | Mar 16, 1990 | SESE |
| K896304 | OLYMPIA FACEPLATE MODULE | Olympia Instruments, Inc. | Jan 26, 1990 | SESE |
| K873031 | STARKEY MODEL P1 MODULE | Starkey Laboratories, Inc. | Feb 8, 1988 | SESE |
| K873300 | SERVICE MASTER (IMPULSE) | Richards Medical Co., Inc. | Dec 8, 1987 | SESE |
| K872645 | 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
- Richards Medical Co., Inc. — 2 clearances
- Maico Hearing Instruments, Inc. — 2 clearances
- Audina Hearing Instrument — 2 clearances
