ClearanceBrief
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

Company510(k)sRecalls
Unitron Industries, Inc.690
Miracle-Ear, Inc.640
Electone, Inc.630
Oticon Corp.630
Widex Hearing Aid Co., Inc.510
Rion Acoustic Instruments, Inc.470
Starkey Laboratories, Inc.390
Telex Communications, Inc.390
Phonak, Inc.370
Beltone Electronics Corp.360
Decided510(k)Device and applicantCode
Aug 22, 1995K953047Z20
Electone, Inc.
ESD
Aug 15, 1995K953054AM 260 OHM
Electone, Inc.
ESD
Aug 15, 1995K953053AM 260 PP
Electone, Inc.
ESD
Aug 15, 1995K953052AM 260 K-AMP
Electone, Inc.
ESD
Aug 15, 1995K953051Z35
Electone, Inc.
ESD
Aug 15, 1995K953049Z24
Electone, Inc.
ESD
Aug 15, 1995K953048Z22
Electone, Inc.
ESD
Aug 7, 1995K952986SPI-SECRET PERSONAL INSTRUMENT CIC
Midwest City Hearing Aid Center
ESD
Jul 28, 1995K952658HEARING AID
Philips Hearing Instruments Co.
ESD
Jul 26, 1995K953266RESOUND PERSONAL HEARING SYSTEM BT250 MZ W/REMOTE CONTROL OPTION
Resound Corp.
ESD
Jul 26, 1995K952940PERSONAL PROGRAMMER 2000
Siemens Hearing Instruments, Inc.
ESD
Jul 21, 1995K953038DYNAMIC EQ/CLASS D
Midwest City Hearing Aid Center
ESD
Jul 21, 1995K953036DB PUSH-PULL HEARING AID
Midwest City Hearing Aid Center
ESD
Jul 21, 1995K952821MWCHAC 95 FS 12345
Midwest City Hearing Aid Center
ESD
Jul 21, 1995K952820MWCHAC 95 C 12345
Midwest City Hearing Aid Center
ESD
Jul 20, 1995K953037CUSTOM CANAL & FULL CONCHA INSTR (CLASS D CIR OPT)
Midwest City Hearing Aid Center
ESD
Jul 11, 1995K951642GOLD CD ULTRA MINI CANAL - MODULE
Electone, Inc.
ESD
Jul 6, 1995K952452OUTPUT COMPRESSION LIMITER WITH ACTIVE TONE CONTROL
Argosy Electronics
ESD
Jul 6, 1995K952451CLASS D LINEAR WITH ACTIVE TONE CONTROL
Argosy Electronics
ESD
Jul 6, 1995K952450WIDE DYNAMIC RANGE COMPRESSION WITH ACTIVE TONE CONTROL
Argosy Electronics
ESD
Jul 3, 1995K952711LORI-A
Lori Medical Laboratories, Inc.
ESD
Jun 30, 1995K951828FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT
Siemens Hearing Instruments, Inc.
ESD
Jun 30, 1995K951587BELTONE PETITE PLUS BELTONE PETITE PLUS CLEARVIOCE K
Beltone Electronics Corp.
ESD
Jun 30, 1995K946232ACURA-EX
Lustgarten Multi-Tech Intl.
ESD
Jun 28, 1995K952097OTOSONIC (OSI) CF 10-K, 10-D
Beltone Electronics Corp.
ESD
Jun 28, 1995K950868BELTONE COMPOSER 2000
Beltone Electronics Corp.
ESD
Jun 21, 1995K952455IMPROVED MANHATTAN II
Argosy Electronics
ESD
Jun 21, 1995K952454EXPANDER WITH ACTIVE TONE CONTROL
Argosy Electronics
ESD
Jun 21, 1995K952453INPUT COMPRSSION LIMITER WITH ACTIVE TONE CONTROL
Argosy Electronics
ESD
Jun 19, 1995K952229WIDEX MODEL LOGO 32 (L32)
Widex Hearing Aid Co., Inc.
ESD
Jun 5, 1995K952263PROGRAMMABLE TWO MEMORY, SINGLE BAND BEHIND THE EAR HEARING INSTRUMENT
Siemens Hearing Instruments, Inc.
ESD
Jun 5, 1995K952228SONAR CIC COMPLETELY IN-THE-CANAL HEARING DEVICE
Resound Corp.
ESD
Jun 2, 1995K951677RIONET HEARING AID HM-02
Authorized Hearing Systems, Inc.
ESD
May 30, 1995K951896INTELIVENIENCE PROGRAMMABLE FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT
Siemens Hearing Instruments, Inc.
ESD
May 25, 1995K950963AUDIOTECH MODEL SPI
Muskogee Regional Hearing Aid Lab
ESD
May 24, 1995K943808RIONET HM-02
Rockwin Corp.
ESD
May 15, 1995K943961THE MODEL ACAPPELLA IN THE EAR HEARING AID
Telex Communications, Inc.
ESD
May 12, 1995K951068RESOUND ED4-M MINI-CANAL PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (RESOUND PHS ED4-M)
Resound Corp.
ESD
May 12, 1995K951067RESOUND ED4-C CANAL PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (RESOUND PHS ED4-C)
Resound Corp.
ESD
Apr 27, 1995K951379RESOUND PERSONAL HEARING SYSTEM MODELS ED3A & ED3A/S W/REMONTE CONTROL OPTION
Resound Corp.
ESD
Apr 27, 1995K951378RESOUND PERSONAL HEARING SYSTEM MODELS BTP2 & BTP2/S W/REMOTE CONTROL OPTION
Resound Corp.
ESD
Apr 14, 1995K951377RESOUND PERSONAL HEARING SYSTEM BTP/S-A W/REMOTE CONTROL OPTION
Resound Corp.
ESD
Apr 14, 1995K951376RESOUND PERSONAL HEARING SYSTEM BT2/S SERIES W/REMOTE CONTROL OPTION
Resound Corp.
ESD
Apr 14, 1995K951375RESOUND PERSONAL HEARING SYSTEM ED3/S-E
Resound Corp.
ESD
Apr 14, 1995K951374RESOUND PERSONAL HEARING SYSTEM BT2/S-E
Resound Corp.
ESD
Apr 13, 1995K946340BELTONE COMPARAFIT
Beltone Electronics Corp.
ESD
Mar 31, 1995K950759UNITRON MODEL ESTEEM
Unitron Industries, Inc.
ESD
Mar 31, 1995K950693MIRACLE-EAR MODEL PM1/PM2 PROGRAMMABLE HEARING AID
Miracle-Ear, Inc.
ESD
Mar 31, 1995K950692MIRACLE-EAR MODEL PBS PROGRAMMABLE HEARING AID
Miracle-Ear, Inc.
ESD
Mar 31, 1995K950691MIRACLE-EAR MODEL PBM PROGRAMMABLE HEARING AID
Miracle-Ear, Inc.
ESD

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