Panels › Ear, Nose, Throat › Product code ESD · Class 1

Hearing Aid, Air-Conduction, Prescription

Regulation 874.3300

0510(k)s in 12 months (1,367 all time)

0recalls in 12 months (4 all time)

1recalls that name a 510(k)

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Top companies in ESD

Company	510(k)s	Recalls
Unitron Industries, Inc.	69	0
Miracle-Ear, Inc.	64	0
Electone, Inc.	63	0
Oticon Corp.	63	0
Widex Hearing Aid Co., Inc.	51	0
Rion Acoustic Instruments, Inc.	47	0
Starkey Laboratories, Inc.	39	0
Telex Communications, Inc.	39	0
Phonak, Inc.	37	0
Beltone Electronics Corp.	36	0

Decided	510(k)	Device and applicant	Code
Nov 14, 1994	K944548	REXPLUS PP3 Rexton, Inc.	ESD
Oct 21, 1994	K944078	PROGRAM 3-CH SER HEAR AIDS W/PROGRAM FIT SYST/PRO FIT Argosy Electronics	ESD
Oct 20, 1994	K944838	WIDEX MODEL LX-ITE Widex Hearing Aid Co., Inc.	ESD
Oct 20, 1994	K944502	BELTONE CONCERTO S Beltone Electronics Corp.	ESD
Oct 20, 1994	K943960	UV CURED METHYL METHACRYLATE HEARING AID SHELL MATERIALS Miracle-Ear, Inc.	ESD
Oct 20, 1994	K943687	FEDELITY F495, VIENNATONE ALPP II Starkey Laboratories, Inc.	ESD
Oct 12, 1994	K944077	PROGRAM 3-CH SERIES HEAR AIDS W/DT-1 DESKTOP PROGRAM Argosy Electronics	ESD
Sep 23, 1994	K943826	MIRACLE-EAR MIRAGE Miracle-Ear, Inc.	ESD
Sep 23, 1994	K942523	MIRACLE-EAR IMPRESSION MATERIAL KIT Miracle-Ear, Inc.	ESD
Sep 21, 1994	K943825	MIRACLE EAR CONFIDANTE Miracle-Ear, Inc.	ESD
Sep 21, 1994	K943788	RESOUND PERSONAL HEARING SYSTEM Resound Corp.	ESD
Sep 16, 1994	K943318	ALL-IN-THE-EAR Golden State Audiology Assoc.	ESD
Sep 7, 1994	K935019	INFINITY 252 Siemens Hearing Instruments, Inc.	ESD
Sep 7, 1994	K934752	SIEMENS MODEL 584 P-2 Siemens Hearing Instruments, Inc.	ESD
Aug 22, 1994	K943706	AUDILENS LLK Widex Hearing Aid Co., Inc.	ESD
Aug 22, 1994	K942857	SIEMENS BTE HEARING AIDS Siemens Hearing Instruments, Inc.	ESD
Aug 18, 1994	K943670	MO6 SERIES Philips Hearing Instruments Co.	ESD
Aug 17, 1994	K943682	SM-VEGA, SM-PC, SM-AGC, SM-AGC-H Starkey Laboratories, Inc.	ESD
Aug 17, 1994	K942895	MIRACLE EAR MODEL PGM Miracle-Ear/Dahlberg, Inc.	ESD
Aug 17, 1994	K942894	MIRACLE-EAR MODEL PGC Miracle-Ear/Dahlberg, Inc.	ESD
Aug 17, 1994	K942893	MIRACLE-EAR MODEL PGF + REMOTE Miracle-Ear/Dahlberg, Inc.	ESD
Aug 9, 1994	K943395	PHILIPS M38 SERIES Philips Hearing Instruments Co.	ESD
Aug 9, 1994	K942189	CRYSTAL EAR Crystal Care Intl., Inc.	ESD
Aug 9, 1994	K941107	THE CANAL (C.I.C.) AKA/HIDDEN EAR Qualitone, Inc.	ESD
Aug 9, 1994	K940667	STARKEY CE-8 TML, STARKEY CE-8 TMC AIR CONDUCTION HEARING AID Starkey Laboratories, Inc.	ESD
Aug 4, 1994	K940670	EARCRAFT HEARING AID Earcraft, Inc.	ESD
Jul 25, 1994	K941859	MIRACLE-EAR EAR IMPRESSION MATERIAL Miracle-Ear/Dahlberg, Inc.	ESD
Jul 20, 1994	K943144	AURIS CIC General Hearing Instruments, Inc.	ESD
Jul 20, 1994	K942831	HAE 2 Hearing Aid Express	ESD
Jul 20, 1994	K942830	HAE 3 Hearing Aid Express	ESD
Jul 20, 1994	K942829	HAE 1 Hearing Aid Express	ESD
Jul 18, 1994	K942749	HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENT Madsen Electronics (Canada) , Ltd.	ESD
Jul 5, 1994	K942594	STAR 42 PP SP STAR 42 DIGITALLY PROGRAMMABLE HEARING AID Starkey Laboratories, Inc.	ESD
Jun 29, 1994	K940164	SUPER-SIL Finetone Hearing Instruments	ESD
Jun 24, 1994	K942036	EUROSTAR SUPER, EUROSTAR VFC Starkey Laboratories, Inc.	ESD
Jun 24, 1994	K941587	HEARING TECH Hearing Tech, Inc.	ESD
Jun 17, 1994	K942213	OPTIMA WITH DELTA AMP Beltone Electronics Corp.	ESD
Jun 17, 1994	K942164	PHILIPS 61 SERIES Philips Hearing Instruments Co.	ESD
Jun 17, 1994	K941295	SHARP II HELIX HEARING AID Miracle-Ear, Inc.	ESD
Jun 15, 1994	K940098	BELTONE INVISA Beltone Electronics Corp.	ESD
May 13, 1994	K941734	PHONAK SONO-FORTE 331X BTE HEARING INSTRUMENTS Phonak, Inc.	ESD
May 13, 1994	K932269	PRO-CONNECT Starkey Laboratories, Inc.	ESD
May 12, 1994	K941294	SHARP II LOW PROFILE HEARING AID Miracle-Ear, Inc.	ESD
May 12, 1994	K941293	SHARP II SEMI CONTOUR HEARING AID Miracle-Ear, Inc.	ESD
May 12, 1994	K941292	SHARP II FULL CONTOUR Miracle-Ear, Inc.	ESD
May 12, 1994	K941133	770-ATC Electone, Inc.	ESD
May 12, 1994	K941122	AUDIOTONE MODEL A-54SR Miracle-Ear, Inc.	ESD
May 12, 1994	K941121	AUDIOTONE MODEL A-54 Miracle-Ear, Inc.	ESD
May 12, 1994	K941039	WAX GUARD OPTION Miracle-Ear, Inc.	ESD
May 4, 1994	K941636	MINI PAK Starkey Laboratories, Inc.	ESD

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