FDA 510(k) Applications for Medical Device Product Code "ESD"
(Hearing Aid, Air Conduction)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K973579 | A & M HEARING, LTD. | AM SERIES HEARING AID | 10/28/1997 |
| K971699 | ARGOSY ELECTRONICS | ARGOSY DYNAMEQ | 07/03/1997 |
| K961729 | ARGOSY ELECTRONICS | ARGOSY PROGRAMMABLE | 05/29/1996 |
| K974242 | ARGOSY ELECTRONICS | ARGOSY PROGRAMMABLE ONQUE | 01/20/1998 |
| K964816 | AUDINA HEARING INSTRUMENT | AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR | 01/17/1997 |
| K963879 | AUTHORIZED HEARING SYSTEMS, INC. | AHS DELTA 22 | 11/26/1996 |
| K963881 | AUTHORIZED HEARING SYSTEMS, INC. | AHS DELTA 22 T | 11/26/1996 |
| K963874 | AUTHORIZED HEARING SYSTEMS, INC. | AHS OMEGA AGC | 11/26/1996 |
| K963877 | AUTHORIZED HEARING SYSTEMS, INC. | AHS OMEGA CONCEPT | 12/06/1996 |
| K963873 | AUTHORIZED HEARING SYSTEMS, INC. | AHS OMEGA DEQ | 11/26/1996 |
| K963878 | AUTHORIZED HEARING SYSTEMS, INC. | AHS OMEGA HF | 12/06/1996 |
| K963875 | AUTHORIZED HEARING SYSTEMS, INC. | AHS OMEGA K-AMP | 11/27/1996 |
| K963876 | AUTHORIZED HEARING SYSTEMS, INC. | AHS OMEGA PP | 11/26/1996 |
| K970057 | AUTHORIZED HEARING SYSTEMS, INC. | AHS OMEGA SP | 02/26/1997 |
| K963154 | AUTHORIZED HEARING SYSTEMS, INC. | RIONET HB-54AS | 09/05/1996 |
| K963152 | AUTHORIZED HEARING SYSTEMS, INC. | RIONET HB-55AS | 09/05/1996 |
| K963153 | AUTHORIZED HEARING SYSTEMS, INC. | RIONET HB-55S | 09/05/1996 |
| K971693 | AUTHORIZED HEARING SYSTEMS, INC. | RIONET HB-79P | 06/06/1997 |
| K961907 | AUTHORIZED HEARING SYSTEMS, INC. | RIONET HEARING AID HB53-K | 07/03/1996 |
| K973846 | BARON TRADING, INC. | AIR CONDUCTION HEARING AID | 10/29/1997 |
| K971852 | BELTONE ELECTRONICS CORP. | AIR CONDUCTION HAEARING AIDS | 08/15/1997 |
| K955930 | BELTONE ELECTRONICS CORP. | BELTONE COMPOSER 2000 BTE HP | 03/01/1996 |
| K963958 | BELTONE ELECTRONICS CORP. | IMPRESS, PERFECTA, ACU-FORM, AND ACUFIT | 12/05/1996 |
| K973948 | BERNAFON-MAICO, INC. | DUALINE 100 BTE | 10/28/1997 |
| K971158 | BERNAFON-MAICO, INC. | DUALINE 400 CIC | 06/13/1997 |
| K974069 | BERNAFON-MAICO, INC. | OPUS 2 - CANAL SERIES (ITC) | 12/15/1997 |
| K974152 | BERNAFON-MAICO, INC. | OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC) | 12/15/1997 |
| K974211 | BERNAFON-MAICO, INC. | OPUS 2 - FULL CONCHA SERIES - ITE | 12/15/1997 |
| K971298 | BETTER HEARING, INC. | BETTER HEARING, INC. MODEL L-1 HEARING AID | 07/23/1997 |
| K973043 | BETTER HEARING, INC. | MODEL C-1 HEARING AID | 10/27/1997 |
| K960741 | COMFORTONE AMERICA'S VALUE HEARING AID LINE | COMFORTONE PHS | 05/07/1996 |
| K955288 | CROWN DELTA CORP. | HEARING AID IMPRESSION MATERIAL | 02/02/1996 |
| K964603 | DECIBEL INSTRUMENTS, INC. | ARTICULAR HEARING AIDS | 12/06/1996 |
| K972776 | EAR TECHNOLOGY CORP. | DRY & STORE | 09/08/1997 |
| K961084 | ELECTONE, INC. | AM 400 | 04/18/1996 |
| K955702 | ELECTONE, INC. | SONATA U-01 | 02/22/1996 |
| K973266 | ELECTONE, INC. | Z DEQ-II | 09/23/1997 |
| K964680 | ETHICAL HEARING INSTRUMENTS | COMFORTAID HEARING AID | 01/24/1997 |
| K963047 | FENWICK HEARING INSTRUMENTS | AIR-CONDUCTION HEARING INSTRUMENTS: MODELS = 227, 229, 232, 216, 216P, 123, 219 (MODIFY) | 09/10/1996 |
| K955692 | FINETONE HEARING INSTRUMENTS | FINETONE FSC, | 02/02/1996 |
| K971399 | GENERAL HEARING INSTRUMENTS, INC. | AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC | 06/13/1997 |
| K974751 | GENERAL HEARING INSTRUMENTS, INC. | TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC | 03/06/1998 |
| K971031 | GN DANAVOX, INC. | AUDALLION III HEARING SYSTEM | 06/17/1997 |
| K971032 | GN DANAVOX, INC. | DANAVOX MODELS 163/162 BTE | 06/17/1997 |
| K971807 | HEAR-RIGHT, INC. | IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL | 08/07/1997 |
| K963745 | HEARING INNOVATIONS, INC. | MODEL WMR BTE HEARING INSTRUMENT (MODEL WMR) | 11/26/1996 |
| K960935 | HEARING SOLUTIONS, INC. | AUDIO 'D' 2N SERIES HEARING AIDS(FULL SHELL ITE,HALF SHELL ITE, MINI CANAL, CANAL) | 04/03/1996 |
| K961308 | HEARING SOLUTIONS, INC. | AUDIO 'D' INTIMA CIC | 05/07/1996 |
| K962798 | HEARING SOLUTIONS, INC. | AUDIO 'D' K-AMP HR FULL SHELL AND CANAL HEARING AIDS | 09/09/1996 |
| K964180 | HEARING SOLUTIONS, INC. | AUDIO 'D' SOUND SELECTOR POWER (SSP) | 11/26/1996 |
| K973927 | HYUNJAE CORP. | HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL | 12/11/1997 |
| K021867 | INSOUND MEDICAL INC. | INSOUND XT SERIES HEARING AID | 11/19/2002 |
| K081136 | INSOUND MEDICAL INC. | LYRIC HEARING AID | 05/08/2008 |
| K964898 | KEYTONE HEARING LABORATORY | IN THE EAR HEARING AID | 04/21/1997 |
| K973376 | LORI MEDICAL LABORATORIES, INC. | LORI/LORI, LORI-S (LORI STOCK AID) | 10/14/1997 |
| K972058 | LORI MEDICAL LABORATORIES, INC. | LORIPRO, LORIPRO II | 08/15/1997 |
| K973861 | MAGNATONE HEARING AID CORP. | FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA 56,57,58,59, SUPREMA 45, 46, 47,48 | 11/19/1997 |
| K973665 | MAGNATONE HEARING AID CORP. | MAGNATONE / STERLING/ ST; MAGNATONE/DB; MAGNATONE/ LIBERTY/ LB; MAGNATONE/ PEARL/PH C.I.C., S.P.I., ONE TOUCH, DESIGNER | 11/04/1997 |
| K960031 | MAICO HEARING INSTRUMENTS, INC. | AUDIOFLEX 120 | 03/07/1996 |
| K972431 | MICRO-EAR TECHNOLOGY, INC. | MERIDIAN DSP | 07/23/1997 |
| K970880 | MICRO-EAR TECHNOLOGY, INC. | POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN | 06/06/1997 |
| K964657 | MICRO-EAR TECHNOLOGY, INC. | SUPER K-AMP, EZ-COMPRESSION, TRIM-PRO, HF-PRO, ENVIRO-PRO, COMPRESSION-PRO, COMPRESSION 3000, HF 3000, OCTIVA, REFLEX HF | 02/11/1997 |
| K962847 | MICRO-TECH HEARING INSTRUMENTS | MT10P, MT60-PP, MT60-AGC0, AND MT60 | 08/09/1996 |
| K970430 | MIDWEST CITY HEARING AID CENTER | ADAPTIVE COMPRESSION - CLASS D/ CLASS D AGCI | 03/11/1997 |
| K963604 | MIDWEST CITY HEARING AID CENTER | DYNAMIC EQ II - 2 CHANNEL WIDE DYNAMIC RANGE COMPRESSION | 09/27/1996 |
| K963607 | MIDWEST CITY HEARING AID CENTER | HORIZON 1 AND 2 PROGRAMABLE FULL SHELL AND IN THE CANAL | 09/20/1996 |
| K965063 | MIRACLE-EAR, INC. | AUDIOTONE (A-552) | 01/27/1997 |
| K965057 | MIRACLE-EAR, INC. | AUDIOTONE (A554H) | 01/27/1997 |
| K965049 | MIRACLE-EAR, INC. | DAHLBERG (A-554) | 01/27/1997 |
| K964530 | MIRACLE-EAR, INC. | DAHLBERG HEARING AID WITH MULTI-CHANNEL COMPRESSION CIRCUIT | 11/27/1996 |
| K964794 | MIRACLE-EAR, INC. | DAHLBERG K-AMP BTE | 12/23/1996 |
| K972345 | MIRACLE-EAR, INC. | DAHLBERG/MIRACLE-EAR | 07/23/1997 |
| K964419 | MIRACLE-EAR, INC. | MIRACLE - EAR (ITE/ITC/CIC) | 02/04/1997 |
| K960804 | MIRACLE-EAR, INC. | MIRACLE EAR & AUDIOTONE MODEL ITE/ITC/CIC | 04/05/1996 |
| K954119 | MIRACLE-EAR, INC. | MIRACLE EAR MIRAGE | 01/24/1996 |
| K972344 | MIRACLE-EAR, INC. | MIRACLE-EAR DIGITAL BTE | 07/23/1997 |
| K972346 | MIRACLE-EAR, INC. | MIRACLE-EAR ITE DIGITAL | 07/23/1997 |
| K964669 | MIRACLE-EAR, INC. | MIRACLE-EAR OR AUDIOTONE | 12/26/1996 |
| K970262 | MIRACLE-EAR, INC. | MULTI-CHANNEL COMPRESSION BTE (SD) | 03/31/1997 |
| K971296 | NATIONAL HEARING AID DIST., INC. | TONDI, MODELS U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A, KA-05 | 06/20/1997 |
| K972039 | NU-SOUND | NEW SOUND HIDDEN AID COMPLETELY IN CANAL (CIC) | 08/25/1997 |
| K963821 | ORSONIQUE, INC. | OVATION AGC-1 | 10/28/1996 |
| K963818 | ORSONIQUE, INC. | OVATION AGC-2 | 10/28/1996 |
| K963822 | ORSONIQUE, INC. | OVATION AGC-3 | 10/28/1996 |
| K963819 | ORSONIQUE, INC. | OVATION ASP | 10/28/1996 |
| K972373 | ORSONIQUE, INC. | OVATION HDP | 07/29/1997 |
| K963820 | ORSONIQUE, INC. | OVATION LINEAR | 10/28/1996 |
| K963788 | OTICON CORP. | PRIMOFOCUS COMPACT | 11/27/1996 |
| K961059 | OTICON, INC. | DIGIFOCUS COMPACT | 05/07/1996 |
| K964683 | OTICON, INC. | DIGIFOCUS ITE | 12/12/1996 |
| K960284 | OTICON, INC. | OTICON /PRIMOFOCUS (PF) | 03/07/1996 |
| K973886 | OTICON, INC. | OTICON DIGISOUND COMPACT | 11/04/1997 |
| K973885 | OTICON, INC. | OTICON DIGISOUND ITE | 11/04/1997 |
| K962228 | OTOTECH INTL., INC. | MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT | 08/28/1996 |
| K960410 | PERFECT EAR | PERFECT EAR PE/PE-AGC/PE-B/PE-PWR | 04/04/1996 |
| K973972 | PERFECT EAR | PERFECT EAR/ MINI-CANAL/ PE-M, PE-ML, PE-MD), PERFECT EAR/ C.I.C./ (PEC, PE-CD) (WITH OR WITHOUT RID-WAX BARRIER) | 11/04/1997 |
| K972818 | PHILIPS HEARING INSTRUMENTS CO. | D72 DIGITAL | 10/17/1997 |
| K965088 | PHILIPS HEARING INSTRUMENTS CO. | M11 SERIES: M11, M11M | 01/24/1997 |
| K961770 | PHILIPS HEARING INSTRUMENTS CO. | PHILIPS 71 SERIES | 08/02/1996 |
| K971804 | PHILIPS HEARING INSTRUMENTS CO. | PHILIPS S1694, S1695 | 06/06/1997 |
| K130790 | PHONAK LLC | LYRIC2 | 06/27/2013 |
| K972105 | PHONAK, INC. | PHONAK EPICA | 08/01/1997 |
| K964035 | PHONAK, INC. | PHONAK MICROLINK, PERSONAL FM RECEIVER | 12/04/1996 |
| K972097 | PHONAK, INC. | PHONAK MICROZOOM P 2 | 07/30/1997 |
| K972106 | PHONAK, INC. | PHONAK NOVO FORTE E3 | 08/15/1997 |
| K961622 | PHONAK, INC. | PHONAK PICONET2 P2 AZ | 05/17/1996 |
| K961653 | PHONAK, INC. | PHONAK SONA P2 | 05/29/1996 |
| K955466 | QUALITONE | DYNAMEQ-II OPTION | 02/13/1996 |
| K961827 | QUALITONE | IN-THE-EAR | 07/03/1996 |
| K970215 | RESOUND CORP. | AUDALLION II HEARING SYSTEM | 03/31/1997 |
| K960684 | RESOUND CORP. | HEARING AID - AIR CONDUCTION | 04/10/1996 |
| K964557 | RESOUND CORP. | RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION | 11/27/1996 |
| K964115 | RESOUND CORP. | RESOUND CC4 PERSONAL HEARING SYSTEM | 11/04/1996 |
| K974257 | RESOUND CORP. | RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER) | 12/12/1997 |
| K971605 | RESOUND CORP. | RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION | 07/03/1997 |
| K960052 | RESOUND CORP. | RESOUND PERSONAL HEARING SYSTEM BT2-ES, BT2-EV, & BT241 | 03/12/1996 |
| K955867 | RESOUND CORP. | RESOUND PERSONAL HEARING SYSTEM BT247 | 02/02/1996 |
| K960680 | RESOUND CORP. | RESOUND PERSONAL HEARING SYSTEMS EDR ENCORE SERIES MODELS EDR-E, EDR-ES, EDR-EV, & EDR-P1 | 04/10/1996 |
| K974081 | RESOUND CORP. | RESOUND STEALTH CIC | 12/12/1997 |
| K960295 | REXTON, INC. | LONG LIFE RX-12 | 03/22/1996 |
| K964451 | REXTON, INC. | PICCOLO K-AMP VC+, PICCOLO P-A1, PICCOLO P-AO AND PICCOLO ATC | 11/27/1996 |
| K970537 | REXTON, INC. | REXTON MODEL 48 AND 49PP | 03/28/1997 |
| K954922 | REXTON, INC. | REXTON'S HORIZION FAMILY OF MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMBALE INSTRUMENTS | 01/17/1996 |
| K974129 | ROCKWIN CORP. | HI-69E, HI-69N, HI-69P | 12/12/1997 |
| K971299 | SCIENTIFIC PLASTICS, INC. | SCIENTIFIC PLASTICS MODEL SP | 06/06/1997 |
| K961670 | SEIG TECHNOLOGIES, INC. | CLARITY | 05/14/1996 |
| K972998 | SIEMENS HEARING INSTRUMENTS, INC. | PRISMA | 09/05/1997 |
| K962170 | SIEMENS HEARING INSTRUMENTS, INC. | SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PP | 07/25/1996 |
| K003558 | SIEMENS HEARING INSTRUMENTS, INC. | TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) | 04/24/2001 |
| K984518 | SONIC INNOVATIONS, INC. | SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL | 03/12/1999 |
| K973880 | SONIX TECHNOLOGIES, INC. | SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM | 01/12/1998 |
| K971845 | SOUND HEARING INSTRUMENTS, INC. | HEARTLAND TECHNOLOGIES, ITE, ITC, CIC | 08/15/1997 |
| K963519 | STARKEY LABORATORIES, INC. | EUROLINE A-675 SERIS | 09/27/1996 |
| K960494 | STARKEY LABORATORIES, INC. | EUROLINE A312 SERIES OF BEHIND THE EAR AIR CONDUCTION HEARING AIDS | 03/01/1996 |
| K970952 | STARKEY LABORATORIES, INC. | PRECISE IMPRESSION KIT | 05/02/1997 |
| K964245 | STARKEY LABORATORIES, INC. | PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS | 02/04/1997 |
| K964214 | STARKEY LABORATORIES, INC. | STARKEY A-13 SEQUEL PROGRAMMABLE, A-13 K-AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS | 11/27/1996 |
| K964244 | STARKEY LABORATORIES, INC. | STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS | 11/27/1996 |
| K961082 | TECHNA TONE | TECHNA TONE | 05/07/1996 |
| K963915 | TELEX COMMUNICATIONS, INC. | TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION | 11/08/1996 |
| K964639 | TELEX COMMUNICATIONS, INC. | TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II | 01/21/1997 |
| K961143 | TELEX COMMUNICATIONS, INC. | TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40 | 05/07/1996 |
| K972552 | TRUTONE | AUDIFON H20 PC/AUDIFON H32 PP | 07/30/1997 |
| K972550 | TRUTONE | AUDIFON H24 AGC/AUDIFON H25 AGC/AUDIFON H30 AGC | 07/31/1997 |
| K972542 | TRUTONE | JAZZ PP AGC-O, JAZZ PP | 07/23/1997 |
| K972543 | TRUTONE | TWIST PPAGC-1, TWIST PP | 07/23/1997 |
| K962388 | UNIQUE HEARING TECHNOLOGY, INC. | IN THE EAR HEARING AID | 09/16/1996 |
| K970828 | UNITED HEARING SYSTEMS, INC. | UHS MICRONET PROGRAMMABLE HEARING AIDS MODELS 901,902,903,906,909/PROGRAMMER | 05/28/1997 |
| K974338 | UNITRON INDUSTRIES, INC. | UNITRON MODEL F/X PROGRAMMABLE (MINI BTE) | 12/12/1997 |
| K964508 | UNITRON INDUSTRIES, INC. | UNITRON MODEL ICON AOHP +4 (ICON AOHP +4) | 11/27/1996 |
| K964510 | UNITRON INDUSTRIES, INC. | UNITRON MODEL ICON AOHPD +4 (ICON AOHPD +4) | 11/27/1996 |
| K964504 | UNITRON INDUSTRIES, INC. | UNITRON MODEL ICON AOHPL +4 | 11/27/1996 |
| K963122 | UNITRON INDUSTRIES, INC. | UNITRON MODEL ICON KR | 09/06/1996 |
| K964503 | UNITRON INDUSTRIES, INC. | UNITRON MODEL SOUND F/X +4 | 11/27/1996 |
| K970692 | UNITRON INDUSTRIES, INC. | UNITRON MODEL SOUND F/X CIC | 05/08/1997 |
| K970519 | UNITRON INDUSTRIES, INC. | UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE) | 04/24/1997 |
| K964511 | UNITRON INDUSTRIES, INC. | UNITRON MODEL SOUND F/XD +4 (SOUND F/XD +4) | 11/27/1996 |
| K974339 | UNITRON INDUSTRIES, INC. | UNITRON MODEL SOUND F/XD PROGRAMMABLE | 12/12/1997 |
| K960155 | UNITRON INDUSTRIES, INC. | UNITRON MODEL SOUND F/XP | 03/07/1996 |
| K964502 | UNITRON INDUSTRIES, INC. | UNITRON MODEL SOUND F/XP +4 | 11/27/1996 |
| K974340 | UNITRON INDUSTRIES, INC. | UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE | 12/12/1997 |
| K972755 | VISTA LABS | V-12 LONG LIFE 675 HEARING AID | 08/05/1997 |
| K970939 | VISTA LABS | VISTA V-38 CIC | 06/06/1997 |
| K965218 | WIDEX HEARING AID CO., INC. | SENSO DIGITAL (C18) | 01/24/1997 |
| K955879 | WIDEX HEARING AID CO., INC. | WIDEX MODEL SENSO DIGITAL (C16) | 02/27/1996 |
| K955878 | WIDEX HEARING AID CO., INC. | WIDEX MODEL SENSO DIGITAL (C8) | 02/12/1996 |
| K965254 | WIDEX HEARING AID CO., INC. | WIDEX MODEL SENSO DIGITAL (C9) | 03/12/1997 |
| K970904 | WIDEX HEARING AID CO., INC. | WIDEX SENSO DIGITAL (CIC) | 03/26/1997 |
| K971535 | WIDEX HEARING AID CO., INC. | WIDEX SENSO DIGITAL (MINI CANAL) | 06/06/1997 |
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