FDA 510(k) Applications for Medical Device:
Hearing Aid, Air Conduction

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K973579 A & M HEARING, LTD. FARADAY RD.
CRAWLEY, WEST SUSSEX RH10 2LS
K971699 ARGOSY ELECTRONICS 10300 WEST 70TH ST.
EDEN PRAIRIE MN 55344
K961729 ARGOSY ELECTRONICS 10300 WEST 70TH ST.
EDEN PRAIRIE MN 55344
K974242 ARGOSY ELECTRONICS 10300 WEST 70TH ST.
EDEN PRAIRIE MN 55344
K964816 AUDINA HEARING INSTRUMENT 150 EAST WILDMERE ST.
LONGWOOD FL 32750
K963879 AUTHORIZED HEARING SYSTEMS, INC. 806 BEAVER ST.
BRISTOL PA 19007
K963881 AUTHORIZED HEARING SYSTEMS, INC. 806 BEAVER ST.
BRISTOL PA 19007
K963874 AUTHORIZED HEARING SYSTEMS, INC. 806 BEAVER ST.
BRISTOL PA 19007
K963877 AUTHORIZED HEARING SYSTEMS, INC. 806 BEAVER ST.
BRISTOL PA 19007
K963873 AUTHORIZED HEARING SYSTEMS, INC. 806 BEAVER ST.
BRISTOL PA 19007
K963878 AUTHORIZED HEARING SYSTEMS, INC. 806 BEAVER ST.
BRISTOL PA 19007
K963875 AUTHORIZED HEARING SYSTEMS, INC. 806 BEAVER ST.
BRISTOL PA 19007
K963876 AUTHORIZED HEARING SYSTEMS, INC. 806 BEAVER ST.
BRISTOL PA 19007
K970057 AUTHORIZED HEARING SYSTEMS, INC. 806 BEAVER ST.
BRISTOL PA 19007
K963154 AUTHORIZED HEARING SYSTEMS, INC. 806 BEAVER ST.
BRISTOL PA 19007
K963152 AUTHORIZED HEARING SYSTEMS, INC. 806 BEAVER ST.
BRISTOL PA 19007
K963153 AUTHORIZED HEARING SYSTEMS, INC. 806 BEAVER ST.
BRISTOL PA 19007
K971693 AUTHORIZED HEARING SYSTEMS, INC. 806 BEAVER ST.
BRISTOL PA 19007
K961907 AUTHORIZED HEARING SYSTEMS, INC. 806 BEAVER ST.
BRISTOL PA 19007
K973846 BARON TRADING, INC. 22305 DUNMORE DR.
CALABASAS CA 91302
K971852 BELTONE ELECTRONICS CORP. 4201 WEST VICTORIA ST.
CHICAGO IL 60646
K955930 BELTONE ELECTRONICS CORP. 4201 WEST VICTORIA ST.
CHICAGO IL 60646
K963958 BELTONE ELECTRONICS CORP. 4201 WEST VICTORIA ST.
CHICAGO IL 60646
K973948 BERNAFON-MAICO, INC. 9675 WEST 76TH ST.
EDEN PRAIRIE MN 55344
K971158 BERNAFON-MAICO, INC. 9675 WEST 76TH ST.
EDEN PRAIRIE MN 55344
K974069 BERNAFON-MAICO, INC. 9675 WEST 76TH ST.
EDEN PRAIRIE MN 55344
K974152 BERNAFON-MAICO, INC. 9675 WEST 76TH ST.
EDEN PRAIRIE MN 55344
K974211 BERNAFON-MAICO, INC. 9675 WEST 76TH ST.
EDEN PRAIRIE MN 55344
K971298 BETTER HEARING, INC. 112 ELDEN ST.
HERNDON VA 20170-4809
K973043 BETTER HEARING, INC. 112 ELDEN ST.
HERNDON VA 20170-4809
K960741 COMFORTONE AMERICA'S VALUE HEARING AID LINE 851 NORTH WEST ST.
WICHITA KS 67203
K955288 CROWN DELTA CORP. 1550 FRONT ST.
YORKTOWN HEIGHTS NY 10598
K964603 DECIBEL INSTRUMENTS, INC. 9223 ILONA LN.
HOUSTON TX 77025-4218
K972776 EAR TECHNOLOGY CORP. 207 EAST MYRTLE AVE.
JOHNSON CITY TN 37601
K961084 ELECTONE, INC. 1124 FLORIDA CENTRAL PKWY.
LONGWOOD FL 32750
K955702 ELECTONE, INC. 1124 FLORIDA CENTRAL PKWY.
LONGWOOD FL 32750
K973266 ELECTONE, INC. 1124 FLORIDA CENTRAL PKWY.
LONGWOOD FL 32750
K964680 ETHICAL HEARING INSTRUMENTS 90 FLEET ST.
PORTSMOUTH NH 03801
K963047 FENWICK HEARING INSTRUMENTS 2188 S.W. PARK PLACE,
PORTLAND OR 97205
K955692 FINETONE HEARING INSTRUMENTS 301 U.S. RT. 1
SCARBOROUGH ME 04074
K971399 GENERAL HEARING INSTRUMENTS, INC. 175 BROOKHOLLOW ESPL.
HARAHAN LA 70123
K974751 GENERAL HEARING INSTRUMENTS, INC. 175 BROOKHOLLOW ESPL.
HARAHAN LA 70123
K971031 GN DANAVOX, INC. 5600 ROWLAND RD., SUITE 250
MINNETONKA MN 55343
K971032 GN DANAVOX, INC. 5600 ROWLAND RD., SUITE 250
MINNETONKA MN 55343
K971807 HEAR-RIGHT, INC. 2606 VILLA PROM, SUITE 74
OKLAHOMA CITY OK 73107
K963745 HEARING INNOVATIONS, INC. 3567 EAST SUNRISE DR.
TUCSON AZ 85718
K960935 HEARING SOLUTIONS, INC. 1776 E. LANCASTER AVE.
PAOLI PA 19301
K961308 HEARING SOLUTIONS, INC. 1776 E. LANCASTER AVE.
PAOLI PA 19301
K962798 HEARING SOLUTIONS, INC. 1776 E. LANCASTER AVE.
PAOLI PA 19301
K964180 HEARING SOLUTIONS, INC. 1776 E. LANCASTER AVE.
PAOLI PA 19301
K973927 HYUNJAE CORP. 8 SOUTH END PLAZA
NEW MILFORD CT 06776
K021867 INSOUND MEDICAL INC. 37500 CENTRAL COURT
NEWARK CA 94560
K081136 INSOUND MEDICAL INC. 39660 EUREKA DRIVE
NEWARK CA 94560
K964898 KEYTONE HEARING LABORATORY 11701 I-30, SUITE 100
LITTLE ROCK AR 72209
K973376 LORI MEDICAL LABORATORIES, INC. 696 MENDELSSOHN AVE. NORTH
GOLDEN VALLEY MN 55427-4306
K972058 LORI MEDICAL LABORATORIES, INC. 696 MENDELSSOHN AVE. NORTH
GOLDEN VALLEY MN 55427-4306
K973861 MAGNATONE HEARING AID CORP. P.O. BOX 180964
CASSELBERRY FL 32718-0964
K973665 MAGNATONE HEARING AID CORP. 170 N. CYPRESS WAY
CASSELBERRY FL 32718-0964
K960031 MAICO HEARING INSTRUMENTS, INC. 7375 BUSH LAKE RD.
MINNEAPOLIS MN 55439-2029
K972431 MICRO-EAR TECHNOLOGY, INC. 3500 HOLLY LN. NORTH, #10
PLYMOUTH MN 55447
K970880 MICRO-EAR TECHNOLOGY, INC. 6222 BURY DR.
EDEN PRAIRIE MN 55346-0124
K964657 MICRO-EAR TECHNOLOGY, INC. 3500 HOLLY LN. NORTH, #10
PLYMOUTH MN 55447
K962847 MICRO-TECH HEARING INSTRUMENTS P.O. BOX 59124
MINNEAPOLIS MN 55459-0124
K970430 MIDWEST CITY HEARING AID CENTER 1401 SOUTH MIDWEST BLVD.
MIDWEST CITY OK 73110
K963604 MIDWEST CITY HEARING AID CENTER 1401 SOUTH MIDWEST BLVD.
MIDWEST CITY OK 73110
K963607 MIDWEST CITY HEARING AID CENTER 1401 SOUTH MIDWEST BLVD.
MIDWEST CITY OK 73110
K965063 MIRACLE-EAR, INC. 4101 DAHLBERG DR.
GOLDEN VALLEY MN 55422
K965057 MIRACLE-EAR, INC. 4101 DAHLBERG DR.
GOLDEN VALLEY MN 55422
K965049 MIRACLE-EAR, INC. 4101 DAHLBERG DR.
GOLDEN VALLEY MN 55422
K964530 MIRACLE-EAR, INC. 4101 DAHLBERG DR.
GOLDEN VALLEY MN 55422
K964794 MIRACLE-EAR, INC. 4101 DAHLBERG DR.
GOLDEN VALLEY MN 55422
K972345 MIRACLE-EAR, INC. 4101 DAHLBERG DR.
GOLDEN VALLEY MN 55422
K964419 MIRACLE-EAR, INC. 4101 DAHLBERG DR.
GOLDEN VALLEY MN 55422
K960804 MIRACLE-EAR, INC. 4101 DAHLBERG DR.
GOLDEN VALLEY MN 55422
K954119 MIRACLE-EAR, INC. 4101 DAHLBERG DR.
GOLDEN VALLEY MN 55422
K972344 MIRACLE-EAR, INC. 4101 DAHLBERG DR.
GOLDEN VALLEY MN 55422
K972346 MIRACLE-EAR, INC. 4101 DAHLBERG DR.
GOLDEN VALLEY MN 55422
K964669 MIRACLE-EAR, INC. 4101 DAHLBERG DR.
GOLDEN VALLEY MN 55422
K970262 MIRACLE-EAR, INC. 4101 DAHLBERG DR.
GOLDEN VALLEY MN 55422
K971296 NATIONAL HEARING AID DIST., INC. 301 U.S. RT. 1
SCARBOROUGH ME 04074
K972039 NU-SOUND 2501 WEST MEMORIAL
OKLAHOMA CITY OK 73134
K963821 ORSONIQUE, INC. 4025 BOUL. INDUSTRIEL
LAVAL, QUEBEC H7L 4S3
K963818 ORSONIQUE, INC. 4025 BOUL. INDUSTRIEL
LAVAL, QUEBEC H7L 4S3
K963822 ORSONIQUE, INC. 4025 BOUL. INDUSTRIEL
LAVAL, QUEBEC H7L 4S3
K963819 ORSONIQUE, INC. 4025 BOUL. INDUSTRIEL
LAVAL, QUEBEC H7L 4S3
K972373 ORSONIQUE, INC. 4025 BLVD. INDUSTRIEL, #100
LAVAL, QUEBEC H7L 4S3
K963820 ORSONIQUE, INC. 4025 BOUL. INDUSTRIEL
LAVAL, QUEBEC H7L 4S3
K963788 OTICON CORP. 29 SCHOOLHOUSE RD.
SOMERSET NJ 08873
K961059 OTICON, INC. 29 SCHOOLHOUSE RD.
SOMERSET NJ 08873
K964683 OTICON, INC. 29 SCHOOLHOUSE RD.
SOMERSET NJ 08873
K960284 OTICON, INC. 29 SCHOOLHOUSE RD.
SOMERSET NJ 08873
K973886 OTICON, INC. 29 SCHOOLHOUSE RD.
SOMERSET NJ 08873
K973885 OTICON, INC. 29 SCHOOLHOUSE RD.
SOMERSET NJ 08873
K962228 OTOTECH INTL., INC. 3400 N.W. 56TH
OKLAHOMA CITY OK 73112
K960410 PERFECT EAR P.O. BOX 958405
LAKE MARY FL 32795
K973972 PERFECT EAR 130 EAST EVERGREEN AVE.,
LONGWOOD FL 32750
K972818 PHILIPS HEARING INSTRUMENTS CO. 91 MCKEE DR.
MAHWAH NJ 07430
K965088 PHILIPS HEARING INSTRUMENTS CO. 91 MCKEE DR.
MAHWAH NJ 07430
K961770 PHILIPS HEARING INSTRUMENTS CO. 91 MCKEE DR.
MAHWAH NJ 07430
K971804 PHILIPS HEARING INSTRUMENTS CO. 91 MCKEE DR.
MAHWAH NJ 07430
K130790 PHONAK LLC 555 THIRTEENTH STREET, NW
WASHINGTON DC 20004
K972105 PHONAK, INC. 850 E. DIEHL RD.
NAPERVILLE IL 60566
K964035 PHONAK, INC. 850 E. DIEHL RD.
NAPERVILLE IL 60566
K972097 PHONAK, INC. 850 E. DIEHL RD.
NAPERVILLE IL 60566
K972106 PHONAK, INC. 850 E. DIEHL RD.
NAPERVILLE IL 60566
K961622 PHONAK, INC. 850 E. DIEHL RD.
NAPERVILLE IL 60566
K961653 PHONAK, INC. 850 E. DIEHL RD.
NAPERVILLE IL 60566
K955466 QUALITONE 4931 WEST 35TH ST.
MINNEAPOLIS MN 55416
K961827 QUALITONE 4931 WEST 35TH ST.
MINNEAPOLIS MN 55416
K970215 RESOUND CORP. 220 SAGINAW DRIVE,
REDWOOD CITY CA 94063
K960684 RESOUND CORP. 220 SAGINAW DRIVE,
REDWOOD CITY CA 94063
K964557 RESOUND CORP. 220 SAGINAW DRIVE,
REDWOOD CITY CA 94063
K964115 RESOUND CORP. 220 SAGINAW DRIVE,
REDWOOD CITY CA 94063
K974257 RESOUND CORP. 2182 35TH AVE., CT.
GREELEY CO 80634
K971605 RESOUND CORP. 220 SAGINAW DRIVE,
REDWOOD CITY CA 94063
K960052 RESOUND CORP. 220 SAGINAW DRIVE,
REDWOOD CITY CA 94063
K955867 RESOUND CORP. 220 SAGINAW DRIVE,
REDWOOD CITY CA 94063
K960680 RESOUND CORP. 220 SAGINAW DRIVE,
REDWOOD CITY CA 94063
K974081 RESOUND CORP. 220 SAGINAW DRIVE,
REDWOOD CITY CA 94063
K960295 REXTON, INC. 2415 XENIUM LN.
PLYMOUTH MN 55441
K964451 REXTON, INC. 2415 XENIUM LN.
PLYMOUTH MN 55441
K970537 REXTON, INC. 2415 XENIUM LN.
PLYMOUTH MN 55441
K954922 REXTON, INC. 2415 XENIUM LN.
PLYMOUTH MN 55441
K974129 ROCKWIN CORP. 105 NORTH FIRST ST.
DEKALB IL 60115
K971299 SCIENTIFIC PLASTICS, INC. 243 WEST 30TH ST.
NEW YORK NY 10001
K961670 SEIG TECHNOLOGIES, INC. 126 HWY 64W
MURPHY NC 28906
K972998 SIEMENS HEARING INSTRUMENTS, INC. 10 CONSTITUTION AVE.
PISCATAWAY NJ 08855
K962170 SIEMENS HEARING INSTRUMENTS, INC. 10 CONSTITUTION AVE.
PISCATAWAY NJ 08855
K003558 SIEMENS HEARING INSTRUMENTS, INC. 10 CONSTITUTION AVE.
PISCATAWAY NJ 08855
K984518 SONIC INNOVATIONS, INC. 5330 SOUTH 900 EAST, SUITE 240
SALT LAKE CITY UT 84117
K973880 SONIX TECHNOLOGIES, INC. 5330 SOUTH 900 EAST, SUITE 240
SALT LAKE CITY UT 84117
K232999 Sonova AG 28 Laubisruetistrasse
Staefa 8712
K971845 SOUND HEARING INSTRUMENTS, INC. 4808 NICOLLET AVE SO.
MINNEAPOLIS MN 55409
K963519 STARKEY LABORATORIES, INC. 6600-6700 WASHINGTON AVE.SOUTH
EDEN PRAIRIE MN 55344
K960494 STARKEY LABORATORIES, INC. 6600 WASHINGTON AVE. SOUTH
EDEN PRAIRIE MN 55344
K970952 STARKEY LABORATORIES, INC. 6700 WASHINGTON AVE. SOUTH
EDEN PRAIRIE MN 55344
K964245 STARKEY LABORATORIES, INC. 6600-6700 WASHINGTON AVE.SOUTH
EDEN PRAIRIE MN 55344
K964214 STARKEY LABORATORIES, INC. 6600-6700 WASHINGTON AVE.SOUTH
EDEN PRAIRIE MN 55344
K964244 STARKEY LABORATORIES, INC. 6600 WASHINGTON AVE. SOUTH
EDEN PRAIRIE MN 55344
K961082 TECHNA TONE 350 N. BELT EAST #255
HOUSTON TX 77060
K963915 TELEX COMMUNICATIONS, INC. 9600 ALDRICH AVENUE SOUTH
MINNEAPOLIS MN 55420
K964639 TELEX COMMUNICATIONS, INC. 9600 ALDRICH AVENUE SOUTH
MINNEAPOLIS MN 55420
K961143 TELEX COMMUNICATIONS, INC. 9600 ALDRICH AVENUE SOUTH
MINNEAPOLIS MN 55420
K972552 TRUTONE 3113 SOUTH 115TH EAST AVE.
TULSA OK 74146
K972550 TRUTONE 3113 SOUTH 115TH EAST AVE.
TULSA OK 74146
K972542 TRUTONE 3113 SOUTH 115TH EAST AVE.
TULSA OK 74146
K972543 TRUTONE 3113 SOUTH 115TH EAST AVE.
TULSA OK 74146
K962388 UNIQUE HEARING TECHNOLOGY, INC. 7000 57TH AVE. NORTH, #125
CRYSTAL MN 55429
K970828 UNITED HEARING SYSTEMS, INC. 731-B NORWICH RD.
PLAINFIELD CT 06374
K974338 UNITRON INDUSTRIES, INC. 3555 WALNUT ST.
PORT HURON MI 48061-5010
K964508 UNITRON INDUSTRIES, INC. 3555 WALNUT ST.
PORT HURON MI 48061-5010
K964510 UNITRON INDUSTRIES, INC. 3555 WALNUT ST.
PORT HURON MI 48061-5010
K964504 UNITRON INDUSTRIES, INC. 3555 WALNUT ST.
PORT HURON MI 48061-5010
K963122 UNITRON INDUSTRIES, INC. 3555 WALNUT ST.
PORT HURON MI 48061-5010
K964503 UNITRON INDUSTRIES, INC. 3555 WALNUT ST.
PORT HURON MI 48061-5010
K970692 UNITRON INDUSTRIES, INC. 3555 WALNUT ST.
PORT HURON MI 48061-5010
K970519 UNITRON INDUSTRIES, INC. 3555 WALNUT ST.
PORT HURON MI 48061-5010
K964511 UNITRON INDUSTRIES, INC. 3555 WALNUT ST.
PORT HURON MI 48061-5010
K974339 UNITRON INDUSTRIES, INC. 3555 WALNUT ST.
PORT HURON MI 48061-5010
K960155 UNITRON INDUSTRIES, INC. 3555 WALNUT ST.
PORT HURON MI 48061-5010
K964502 UNITRON INDUSTRIES, INC. 3555 WALNUT ST.
PORT HURON MI 48061-5010
K974340 UNITRON INDUSTRIES, INC. 3555 WALNUT ST.
PORT HURON MI 48061-5010
K972755 VISTA LABS 409 S. TOWER
CENTRALIA WA 98531
K970939 VISTA LABS 409 S. TOWER
CENTRALIA WA 98531
K965218 WIDEX HEARING AID CO., INC. 35-53 24TH ST.
LONG ISLAND CITY NY 11106
K955879 WIDEX HEARING AID CO., INC. 35-53 24TH ST.
LONG ISLAND CITY NY 11106
K955878 WIDEX HEARING AID CO., INC. 35-53 24TH ST.
LONG ISLAND CITY NY 11106
K965254 WIDEX HEARING AID CO., INC. 35-53 24TH ST.
LONG ISLAND CITY NY 11106
K970904 WIDEX HEARING AID CO., INC. 35-53 24TH ST.
LONG ISLAND CITY NY 11106
K971535 WIDEX HEARING AID CO., INC. 35-53 24TH ST.
LONG ISLAND CITY NY 11106




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