Product Code: LRB FDA class 1 21 CFR 874.3300

Face Plate Hearing Aid

Ear, Nose, Throat

A face plate hearing aid is a type of hearing aid configured with a faceplate housing, typically used with behind-the-ear or in-the-ear designs, which amplifies sound to assist individuals with hearing loss. It is classified as a Class 1 (lowest risk) device, subject only to general controls, representing the least burdensome regulatory category. The product code is LRB, regulated under 21 CFR 874.3300, within the Ear, Nose, and Throat medical specialty. No special flags apply to this device.

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FEI Numbers

Registration Numbers

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Basic Information

Product Code: LRB
Device Class: FDA class 1
Regulation Number: 874.3300
Medical Specialty: Ear, Nose, Throat
Review Panel: EN
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 24 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K974219	FACEPLATE ASSEMBLY	Feb 20, 1998	Substantially Equivalent	Finetone Hearing Instruments
K961593	INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS	Nov 07, 1996	Substantially Equivalent	Segi Hearing Aid Co.
K942722	MODULE PROGRAM	Sep 06, 1994	Substantially Equivalent	Electone, Inc.
K942236	AUDINA PREWIRES (FACEPLATE HEARING AID SERIES)	Jun 17, 1994	Substantially Equivalent	Audina Hearing Instrument
K935048	ARTISAN PROGRAMMER & HEARING AID	Feb 09, 1994	Substantially Equivalent	Telex Communications, Inc.
K933046	SILVER L MODULE, ITE	Aug 02, 1993	Substantially Equivalent	Electone, Inc.
K933045	SILVER RECHARGEABLE MODULE, ITE	Aug 02, 1993	Substantially Equivalent	Electone, Inc.
K933044	SILVER LD MODULE, ITE	Aug 02, 1993	Substantially Equivalent	Electone, Inc.
K933043	SILVER PPP MODULE, ITE	Aug 02, 1993	Substantially Equivalent	Electone, Inc.
K933040	GOLD CD MODULE, ITE	Aug 02, 1993	Substantially Equivalent	Electone, Inc.
K933039	GOLD L MODULE, ITE	Aug 02, 1993	Substantially Equivalent	Electone, Inc.
K933038	GOLD AF MODULE, ITE	Aug 02, 1993	Substantially Equivalent	Electone, Inc.
K933037	GOLD K AMP, ITE	Aug 02, 1993	Substantially Equivalent	Electone, Inc.
K910901	FACEPLATE ITE HEARING AID MODEL 28A	May 30, 1991	Substantially Equivalent	Telex Communications, Inc.
K910900	FACEPLATE ITE HEARING AID MODEL TCA	May 30, 1991	Substantially Equivalent	Telex Communications, Inc.
K897023	OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID	Mar 16, 1990	Substantially Equivalent	Audina Hearing Instrument
K896304	OLYMPIA FACEPLATE MODULE	Jan 26, 1990	Substantially Equivalent	Olympia Instruments, Inc.
K873031	STARKEY MODEL P1 MODULE	Feb 08, 1988	Substantially Equivalent	Starkey Laboratories, Inc.
K873300	SERVICE MASTER (IMPULSE)	Dec 08, 1987	Substantially Equivalent	Richards Medical Co., Inc.
K872645	AIR CONDUCTION IN-THE-EAR HEARING AID UA/115/SCR	Dec 08, 1987	Substantially Equivalent	Richards Medical Co., Inc.
K871884	IN THE EAR & IN THE CANAL HEARING AID FACE PLATE	Oct 27, 1987	Substantially Equivalent	Hearing Services, Inc.
K862769	FACEPLATE, CUSTOM IN-THE-EAR HEARING AID, FPR	Aug 13, 1986	Substantially Equivalent	Maico Hearing Instruments, Inc.
K862768	FACEPLATE, CUSTOM IN-THE-EAR HEARING AID, MCA10	Aug 13, 1986	Substantially Equivalent	Maico Hearing Instruments, Inc.
K834479	RELIABLE	Jul 11, 1984	Substantially Equivalent	Reliable Hearing Aide