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 19, 1993	K934597	CLARIFIER II CIRCUIT OPTION Miracle-Ear, Inc.	ESD
Nov 19, 1993	K934586	PROGRAMMABLE AIR CONDUCTION BEHIND THE EAR HEARING AID Unitron Industries, Inc.	ESD
Nov 19, 1993	K934480	RIONET HEARING AID HA-73 Authorized Hearing Systems, Inc.	ESD
Nov 19, 1993	K934479	RIONET HEARING AID HA-72 Authorized Hearing Systems, Inc.	ESD
Nov 3, 1993	K931372	RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM Resound Corp.	ESD
Nov 2, 1993	K933546	V-SIL Esschem, Inc.	ESD
Oct 13, 1993	K934452	HI BAND Argosy Electronics	ESD
Oct 8, 1993	K934454	MANHATTAN II Argosy Electronics	ESD
Oct 8, 1993	K934453	3-CHANNEL CLOCK Argosy Electronics	ESD
Oct 8, 1993	K934450	MANHATTAN 3-CHANNEL Argosy Electronics	ESD
Oct 8, 1993	K934449	3-CHANNEL K-AMP Argosy Electronics	ESD
Oct 8, 1993	K934448	POWER 3-CHANNEL-CLOCK Argosy Electronics	ESD
Oct 8, 1993	K934447	LINEAR PLUS-POWER Argosy Electronics	ESD
Oct 8, 1993	K934446	POWER MANHATTAN II Argosy Electronics	ESD
Oct 8, 1993	K934444	K-AMP Argosy Electronics	ESD
Oct 8, 1993	K934443	2:1 INPUT COMPRESSION Argosy Electronics	ESD
Oct 8, 1993	K934442	LINEAR PLUS Argosy Electronics	ESD
Oct 7, 1993	K933989	RESOLUTION ITC HEARING AID Starkey Laboratories, Inc.	ESD
Oct 7, 1993	K933988	BOSCH EUROSTAR Starkey Laboratories, Inc.	ESD
Oct 7, 1993	K933407	STARKEY TYMPANETTE HEARING AID Starkey Laboratories, Inc.	ESD
Sep 18, 1993	K923006	AS-90 Qualitone	ESD
Sep 7, 1993	K933850	PHILIPS 45 SERIES Philips Hearing Instruments Co.	ESD
Aug 23, 1993	K933644	WIDEX MODEL LOGO 8 (L8) Widex Hearing Aid Co., Inc.	ESD
Aug 23, 1993	K933643	WIDEX MODEL LOGO 6 (L6) Widex Hearing Aid Co., Inc.	ESD
Aug 23, 1993	K933640	WIDEX MODEL LOGO 12 (L12) Widex Hearing Aid Co., Inc.	ESD
Aug 23, 1993	K933579	MEMOREX ARTISAN SYSTEM/ARTISAN PROGRAMMER AND CUSTOM HEARING AID Telex Communications, Inc.	ESD
Aug 23, 1993	K933307	MULTIFOCUS COMPACT BTE HEARING AID Oticon, Inc.	ESD
Aug 23, 1993	K933291	MAICO BTE MODEL RD-111 AND ITE MODEL RD-312 HEARING AID Maico Hearing Instruments, Inc.	ESD
Aug 19, 1993	K932703	BELTONE PRIMA 2000 Beltone Electronics Corp.	ESD
Aug 9, 1993	K930909	PRIZM HEARING SYSTEM Audioscience, Inc.	ESD
Aug 5, 1993	K932670	OTICON MF Oticon Corp.	ESD
Aug 2, 1993	K933042	SILVER COMPRESSION MODULE, ITE Electone, Inc.	ESD
Aug 2, 1993	K933036	GOLD ASP MODULE, ITE Electone, Inc.	ESD
Jul 27, 1993	K933113	STARKEY TRILOGY II PROGRAMMABLE HEARING AID Starkey Laboratories, Inc.	ESD
Jul 27, 1993	K932735	PHONAK PICO-FORTE SC-D-2 Phonak, Inc.	ESD
Jul 27, 1993	K932734	PHONAK PICO-FORTE SC-2 Phonak, Inc.	ESD
Jul 26, 1993	K933095	351-AGCO BEHIND-THE-EAR HEARING AID Telex Communications, Inc.	ESD
Jul 20, 1993	K931942	RESOUND PERSONAL HEARING SYSTEM BT-P W/PHS BT-P Resound Corp.	ESD
Jul 14, 1993	K932426	BELTONE OPERA/OPERA MHP/OPERA MAX Beltone Electronics Corp.	ESD
Jul 14, 1993	K926150	VINYL ADDITION SILICONE SYSTEM Crown Delta Corp.	ESD
Jul 8, 1993	K932175	PHONAK LEXA 231X ITE SERIES HEARING SINSTRUMENT Phonak, Inc.	ESD
Jul 2, 1993	K932058	BELTONE OPTIMA 2000 ITE HEARING AID Beltone Electronics Corp.	ESD
Jul 2, 1993	K931881	IN THE CANAL AID OTOSONIC ACS II WITH SRR Beltone Electronics Corp.	ESD
Jun 24, 1993	K922502	M32 IN THE EAR HEARING AID Electone, Inc.	ESD
Jun 24, 1993	K922501	M30 IN THE EAR HEARING AID Electone, Inc.	ESD
Jun 22, 1993	K931975	AUDIOTECH MODEL DP Muskogee Regional Hearing Aid Lab	ESD
Jun 14, 1993	K932189	IN-THE-EAR HEARING AID Lifestyle Hearing, Inc.	ESD
Jun 14, 1993	K932105	HEARING AIDS Katz Hearing Aid Center	ESD
Jun 8, 1993	K931984	PERFECT EAR/PE Perfect Ear	ESD
Jun 1, 1993	K931161	SERIES STAR 22 - BEHIND THE EAR HEARING AID Maico Hearing Instruments, Inc.	ESD

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