EWO · Audiometer
Ear, Nose, Throat · 21 CFR 874.1050 · Class 2
Overview
| Product Code | EWO |
|---|---|
| Device Name | Audiometer |
| Regulation | 21 CFR 874.1050 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
Identification
An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.
Classification Rationale
Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.
Cleared Devices (235)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K234095 | OtoNova/OtoNova Pro | Otodynamics | Jun 21, 2024 | SESE |
| K240430 | Otoport Pro | Otodynamics, Ltd. | Mar 15, 2024 | SESE |
| K231545 | hearOAE | Hearx SA (Pty) , Ltd. | Oct 27, 2023 | SESE |
| K213345 | Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE | Path Medical GmbH | Jun 22, 2022 | SESE |
| K191372 | Lyra | Interacoustics A/S | Jul 15, 2019 | SESE |
| K180287 | GSI Corti | Grason-Stadler, Inc. | May 11, 2018 | SESE |
| K173567 | Sera | Interacoustics A/S | Feb 14, 2018 | SESE |
| K172403 | GSI Novus | Grason-Stadler, Inc. | Oct 20, 2017 | SESE |
| K171506 | Easyscreen | Maico Diagnostics GmbH | Aug 29, 2017 | SESE |
| K151025 | iHearTest | Ihear Medical, Inc. | Dec 29, 2015 | SESE |
| K150491 | ER36 Series OAE Test System | Etymotic Research, Inc. | Mar 26, 2015 | SESE |
| K141524 | NEURO-AUDIO | Teleemg, LLC USA | Mar 12, 2015 | SESE |
| K143395 | Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit | Otodynamics, Ltd. | Feb 23, 2015 | SESE |
| K133012 | SENTIERO | Path Medical GmbH | Jun 9, 2014 | SESE |
| K130795 | TITAN | Interacoustics A/S | Jun 20, 2013 | SESE |
| K123624 | OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM | Mimosa Acoustics, Inc. | Mar 28, 2013 | SESE |
| K122496 | AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM | Bio-Logic Systems Corp. | Nov 1, 2012 | SESE |
| K121512 | SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM | Bio-Logic Systems Corp. | Jul 26, 2012 | SESE |
| K112992 | EARLOGIC OAE TESTER | Earlogic Corporation | Apr 20, 2012 | SESE |
| K112247 | A BAER WITH ABAER I/O FUNCTION | Natus Medical Incorporated | Apr 2, 2012 | SESE |
| K111618 | AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION | Natus Medical Incorporated | Dec 28, 2011 | SESE |
| K112733 | ER35 ERO-SCAN PRO HEARING TEST SYSTEM | Etymotic Research, Inc. | Dec 16, 2011 | SESE |
| K103298 | ACAM 5 AUDIOMETER SYSTEM | Acousticon GmbH | Apr 8, 2011 | SESE |
| K092089 | CLARUJUST | Audigence, Inc. | Mar 10, 2010 | SESE |
| K092244 | MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS | Diagnostic Group, LLC | Mar 1, 2010 | SESE |
| K092111 | ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204 | Entomed AB | Oct 2, 2009 | SESE |
| K090406 | EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE | Interacoustics AS | Jul 22, 2009 | SESE |
| K081234 | GN OTOMETRICS INSERT EARPHONES | Gn Otometrics | Jul 14, 2008 | SESE |
| K072033 | OTODYNAMICS OTOPORT | Otodynamics, Ltd. | Nov 13, 2007 | SESE |
| K070880 | ER35 ERO-SCAN PRO HEARING TEST SYSTEM | Etymotic Research, Inc. | Jun 7, 2007 | SESE |
| K063452 | MA 55 MAESTRO | Maico Diagnostics (Diagnostic Group, LLC) | Mar 29, 2007 | SESE |
| K070118 | OTOGRAM, CA3350 | Tympany, Inc. | Mar 7, 2007 | SESE |
| K063338 | HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER | Mimosa Acoustics, Inc. | Jan 4, 2007 | SESE |
| K061744 | COCHLEA-SCAN / COCHLEA-SCAN PLUS | Bio-Logic Systems Corp. | Sep 15, 2006 | SESE |
| K060883 | PILOT TEST OR DETECTIVE AUDIOMETERS | Interacoustics A/S | Jun 23, 2006 | SESE |
| K060885 | MODEL MI 44 TYMPANOMETER | Maico-Diagnostics | Jun 5, 2006 | SESE |
| K060539 | DPOAE20 , ECLIPSE | Interacoustics A/S, Assens | May 30, 2006 | SESE |
| K053216 | HEARID WIDEBAND MIDDLE EAR POWER ANALYZER | Mimosa Acoustics, Inc. | Feb 10, 2006 | SESE |
| K052562 | ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS. | Interacoustics AS | Dec 23, 2005 | SESE |
| K043219 | AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS | Interacoustics AS | Feb 4, 2005 | SESE |
| K033108 | VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER | Vivosonic, Inc. | Oct 27, 2003 | SESE |
| K031713 | AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS | Viasys Healthcare, Inc. | Aug 12, 2003 | SESE |
| K031986 | ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS | Ics Medical | Jul 24, 2003 | SESE |
| K031352 | BIO-LOGIC INSERT EARPHONES | Bio-Logic Systems Corp. | Jul 16, 2003 | SESE |
| K030016 | TEOAE25 | Interacoustics A/S, Assens | Mar 28, 2003 | SESE |
| K024205 | AUDIOSCREENER OAE+ABR | Everest Biomedical Instruments Co. | Mar 7, 2003 | SESE |
| K023859 | SMARTTROAE | Intelligent Hearing Systems | Jan 8, 2003 | SESE |
| K021801 | BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS | Bio-Logic Systems Corp. | Jun 27, 2002 | SESE |
| K011135 | GSI AUDERA | Nicolet Biomedical | Jul 26, 2001 | SESE |
| K003364 | VIVO 200 DPS VIVOSCAN | Vivosonic, Inc. | Jul 18, 2001 | SESE |
| K011114 | ETYMOTIC RESEARCH ER-10D OAE PROBE | Etymotic Research | Jul 3, 2001 | SESE |
| K011181 | ICS MEDICAL CHARTR OAE WITH TYMP | Ics Medical Corp. | Jun 25, 2001 | SESE |
| K003913 | HINT AUDIOMETER, OR HINT | Maico-Diagnostics | Mar 16, 2001 | SESE |
| K010165 | ERO SCAN OAE TEST SYSTEM | Etymotic Research | Mar 12, 2001 | SESE |
| K002200 | CAPELLA | Madsen Electronics, Inc. | Aug 25, 2000 | SESE |
| K001058 | AUDIOSCREENER OAE + ABR | Kedly, Inc. | Jun 2, 2000 | SESE |
| K994033 | HORTMANN ECHOMASTER OAE ANALYZER | Hortmann AG | Feb 24, 2000 | SESE |
| K000184 | AUDIOSCREENER OAE | Kedly, Inc. | Feb 11, 2000 | SESE |
| K984547 | DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS | Resound Corp. | Mar 19, 1999 | SESE |
| K983915 | AMPLAID A315 AND A319 | Amplifon S.P.A. | Jan 29, 1999 | SESE |
| K983851 | CAPELLA COCHLEAR EMISSIONS ANALYZER | Madsen Electronics, Inc. | Jan 28, 1999 | SESE |
| K983712 | AMPLAID A311 SERIES | Amplifon S.P.A. | Jan 12, 1999 | SESE |
| K983352 | ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK | Otodynamics, Ltd. | Dec 11, 1998 | SESE |
| K983351 | ILO292 DP ECHOPORT PLUS OAE SYSTEM | Otodynamics, Ltd. | Dec 11, 1998 | SESE |
| K983350 | ILO292 DP ECHOPORT PLUS OAE SYSTEM | Otodynamics, Ltd. | Dec 11, 1998 | SESE |
| K983048 | AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER | American Electromedics Corp. | Nov 17, 1998 | SESE |
| K982878 | EARSCAN 3 | Micro Audiometrics Corp. | Nov 3, 1998 | SESE |
| K982723 | MAICO MA42 | Bernafon-Maico, Inc. | Oct 28, 1998 | SESE |
| K982642 | ECHO-SCREEN | Fischer-Zoth Audiologic Systems, Inc. | Oct 21, 1998 | SESE |
| K982566 | AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM) | Bar - Advanced Control Systems , Ltd. | Oct 21, 1998 | SESE |
| K982441 | CCA-220 | Benson Medical Instruments Co. | Oct 9, 1998 | SESE |
| K982249 | INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER | Idem (Int'L Dist. of Electronics For Medicine) | Aug 7, 1998 | SESE |
| K981511 | OTO WIZZARD | Medrx, Inc. | Jul 24, 1998 | SESE |
| K981439 | CCA-200 | Benson Medical Instruments Co. | Jun 15, 1998 | SESE |
| K981460 | CUB DIS II DPOAE MEASUREMENT SYSTEM | Mimosa Acoustics, Inc. | May 20, 1998 | SESE |
| K981327 | INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER | Idem (Int'L Dist. of Electronics For Medicine) | May 11, 1998 | SESE |
| K981142 | MAICO MA53 | Bernafon-Maico, Inc. | Apr 22, 1998 | SESE |
| K980505 | HORTMANN AMDIS-OAE OAE ANALYZER | Hortmann AG | Apr 7, 1998 | SESE |
| K980533 | ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34) | Etymotic Research | Mar 23, 1998 | SESE |
| K973377 | SIBELMED AC50D | Trutone | Mar 10, 1998 | SESE |
| K974237 | GSI 70 AUDIOPATH SCREENER | Grason-Stadler, Inc. | Feb 10, 1998 | SESE |
| K974076 | SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE | Bio-Logic Systems Corp. | Jan 22, 1998 | SESE |
| K973320 | ARTICULATE FITTING SYSTEM | Decibel Instruments, Inc. | Nov 25, 1997 | SESE |
| K972862 | AMPLAID 171S | Amplifon S.P.A. | Oct 31, 1997 | SESE |
| K972221 | K 15 AUDIOMETER | American Electromedics Corp. | Sep 8, 1997 | SESE |
| K971747 | AMPLAID 460 | Amplifon S.P.A. | Aug 5, 1997 | SESE |
| K971080 | MAICO MA52 | Bernafon-Maico, Inc. | Jun 6, 1997 | SESE |
| K964132 | MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT | Bio-Logic Systems Corp. | May 13, 1997 | SESE |
| K970279 | RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK TYMP 2(AE-QUIK 2) | American Electromedics Corp. | Mar 18, 1997 | SESE |
| K970555 | IL0292 DP ECHOPORT | Smith | Mar 17, 1997 | SESE |
| K964426 | SMARTOAE | Intelligent Hearing Systems | Feb 3, 1997 | SESE |
| K964340 | PORTAREM-3000, PFS-6000 | Starkey Laboratories, Inc. | Jan 10, 1997 | SESE |
| K962995 | ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC | Otodynamics, Ltd. | Jan 10, 1997 | SESE |
| K963681 | CCA-100 (MODIFIED) | Benson Medical Instruments Co. | Oct 8, 1996 | SESE |
| K962275 | MAICO MA25 SERIES II WITH SPEECH | Bernafon-Maico, Inc. | Sep 5, 1996 | SESE |
| K962012 | ETHICAL HEARING INSTRUMENTS/WIZARD HEARING PROFILE TESTER | Ethical Hearing Instruments | Aug 21, 1996 | SESE |
| K961447 | SCOUT SPORT - A MODIFICATION TO (FORMERLY EMAV) OTOACOUSTIC EMISSIONS (OAE) TEST INSTRUMENT | Bio-Logic Systems Corp. | May 29, 1996 | SESE |
| K953814 | OTOSCAPE | Soundscape Technologies, Inc. | Dec 21, 1995 | SESE |
| K953884 | PROPHET | Qualitone | Oct 27, 1995 | SESE |
| K953684 | GSI 61 CLINICAL AUDIOMETER | Grason-Stadler, Inc. | Oct 27, 1995 | SESE |
| K943616 | BELTONE PERSONAL HEARING SCREENER | Beltone Electronics Corp. | Jul 12, 1995 | SESE |
| K951759 | GSI 65 COMPUTERIZED AUDIOMETER | Grason-Stadler, Inc. | Jul 6, 1995 | SESE |
| K943215 | DISPOSABLE AUDIOMETER EARPHONE CUSHION COVER | Kenneth Ullrich | May 12, 1995 | SESE |
| K951527 | THE PILOT AUDIOMETER | American Electromedics Corp. | May 3, 1995 | SESE |
| K945199 | RH2000 REAL EAR MEASUREMENT SYSTEM | Madsen Electronics, Inc. | Apr 11, 1995 | SESE |
| K950888 | SCREENING AUDIOMETRY WORD RECOGNITION AUDIOMETRY | Calmed Technology, Inc. | Mar 21, 1995 | SESE |
| K945689 | GAME AUDIOMETERY WORD IDENTIFICATION AUDIOMETRY FOR USE WITH PRODIGIT(TM) 2000 PERSONAL DIGITAL AUDIOMETER(TM) | Calmed Technology, Inc. | Feb 8, 1995 | SESE |
| K945032 | VOYAGER 522 | Madsen Electronics, Inc. | Feb 2, 1995 | SESE |
| K944735 | BIO-LOGIC EMAV EMISSION AVERAGING OTOACOUSTIC TEST | Bio-Logic Systems Corp. | Dec 21, 1994 | SESE |
| K941920 | INTERACOUSTICS CLINICAL AUDIOMETER | Precision Acoustics Ind., Inc. | Sep 16, 1994 | SESE |
| K942716 | AUDIO EXPERT AUDIOMETER | Beltone Electronics Corp. | Sep 2, 1994 | SESE |
| K943066 | INTERACOUSTICS COMPUTER AUDIOMETER BA 20 | Precision Acoustics Ind., Inc. | Aug 24, 1994 | SESE |
| K931322 | KS 5 - CLINICAL AUDIOMETER | Maico Hearing Instruments, Inc. | Aug 19, 1994 | SESE |
| K943065 | INTERACOUSTICS CLINICAL AUDIOMETER | Precision Acoustics Ind., Inc. | Aug 17, 1994 | SESE |
| K940216 | BELTONE SERIES 100 AUDIOMETERS | Beltone Electronics Corp. | Jul 29, 1994 | SESE |
| K935719 | DAIL A HEARING SCREENING TEST | Occupational Hearing Services | Jul 7, 1994 | SESE |
| K942006 | INTERACOUSTICS DIAGNOSTIC AUDIOMETER | Precision Acoustics Ind., Inc. | Jun 20, 1994 | SESE |
| K934715 | MODEL 222 CLINICAL AUDIOMETER | Virtual Corp. | May 10, 1994 | SESE |
| K940999 | PRODIGIT 2000 | Calmed Technology, Inc. | Apr 22, 1994 | SESE |
| K931325 | OTOACOUSTIC EMISSIONS UNIT CELESTA 503 | Madsen Electronics (Canada) , Ltd. | Feb 18, 1994 | SESE |
| K935348 | ODYSSEY CLINICAL AUDIOMETER | Qualitone | Feb 9, 1994 | SESE |
| K934658 | GSI 60 DPOAE SYSTEM | Lucas Grason-Stadler, Inc. | Feb 1, 1994 | SESE |
| K933097 | SOUND SELECTOR FULL-SERVICE AUDIOMETER | Ensoniq Corp. | Jan 24, 1994 | SESE |
| K934343 | GLASER RT60, RT80, RT150 AUDIOMETER | Glaser Instruments AG | Jan 21, 1994 | SESE |
| K933220 | SELECTOR SL 01 | Futuremed Div. of Future Impex Corp. | Nov 24, 1993 | SESE |
| K931324 | ORBITER 922 CLINICAL AUDIOMETER | Madsen Electronics (Canada) , Ltd. | Nov 19, 1993 | SESE |
| K933222 | AUDIOMETER DA 323 | Futuremed Div. of Future Impex Corp. | Nov 1, 1993 | SESE |
| K930553 | CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT | Etymotic Research | Sep 29, 1993 | SESE |
| K930112 | MAICO MA790 AUDIOMETER | Maico Hearing Instruments, Inc. | Aug 5, 1993 | SESE |
| K926439 | MA25 - PORTABLE AUDIOMETER, MODIFICATION | Maico Hearing Instruments, Inc. | Aug 5, 1993 | SESE |
| K930260 | ACOUSTIC ANALYZER AA30 | Precision Acoustics Ind., Inc. | Jul 13, 1993 | SESE |
| K930003 | TUBEPHONE MODELS ER-3A & ER-3 INSERT EARPHONES | Etymotic Research | Jun 18, 1993 | SESE |
| K926336 | AUDIOSCAN | Electrocaine Medical System | Mar 4, 1993 | SESE |
| K924543 | DSP SCREENING AUDIOMETER | Micro Audiometrics Corp. | Feb 26, 1993 | SESE |
| K923007 | AT-2 | Qualitone | Feb 26, 1993 | SESE |
| K922383 | THE MONITOR MODEL MI-1.2.3 TONE COUNT SCREEN AUDIO | Monitor Instruments, Inc. | Jan 15, 1993 | SESE |
| K922746 | ST 20 PORTABLE AUDIOMETER | Maico Hearing Instruments, Inc. | Nov 5, 1992 | SESE |
| K923074 | DANPLEX SCREENING AUDIOMETER | Life-Tech Intl., Inc. | Sep 23, 1992 | SESE |
| K923013 | ACOUSTIC APPRAISE CD-3 | Qualitone | Aug 14, 1992 | SESE |
| K921085 | PROGRAMMED AUDIOMETRIC DEVICE (PAD)/RECORS (PAR) | Hear-Well Technologies, Inc. | May 15, 1992 | SESE |
| K915323 | THE BELTONE AUDIO SCOUT | Beltone Electronics Corp. | May 11, 1992 | SESE |
| K914232 | ASRA, SCREENING AUDIOMETER | Mercury Electronics (Scot) , Ltd. | Jan 31, 1992 | SESE |
| K913356 | THE MONITOR/DEMLAR MODEL MI-5000 AUDIOMETER | Monitor Instruments, Inc. | Dec 5, 1991 | SESE |
| K913589 | EARSCAN DSP-1 PURE TONE AUDIOMETER | Micro Audiometrics Corp. | Nov 5, 1991 | SESE |
| K913276 | MICROTEK MEDICAL'S SOUND STIKS | Microbio-Medics, Inc. | Oct 21, 1991 | SESE |
| K911689 | MODEL 330 SCREENING AUDIOMETER | Virtual Corp. | Oct 21, 1991 | SESE |
| K913221 | TYPE FA10 AUDIOMETER | Frye Electronics, Inc. | Oct 11, 1991 | SESE |
| K904622 | HEARING CHECKER(TM), DESKTOP MODEL | Qualitone Hearing Aids and Audiometers | Sep 17, 1991 | SESE |
| K912669 | RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM | Resound Corp. | Sep 16, 1991 | SESE |
| K911368 | MAICO MA800 AUDIOMETER | Maico Hearing Instruments, Inc. | Jun 26, 1991 | SESE |
| K900197 | THE MAX SYSTEM, MODEL: BASIC, 1000,2000 AUDIOMETER | Sound Linked Data, Inc. | Apr 17, 1991 | SESE |
| K904544 | ACOUSTIC APPRAISER CD-2 AUDIOMETER/MASTER HEAR.AID | Qualitone | Oct 31, 1990 | SESE |
| K904270 | BIOLINK AUDIOMETER SOFTWARE ACCESSORY | Micro Audiometrics Corp. | Oct 9, 1990 | SESE |
| K903143 | OTOSCREENER-I AND OTO-SCREEN-I-P | Handtronix, Inc. | Sep 19, 1990 | SESE |
| K902068 | HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER | Starkey Laboratories, Inc. | Aug 6, 1990 | SESE |
| K902540 | GSI 17 SCREENING AUDIOMETER | Grason-Stadler, Inc. | Jul 13, 1990 | SESE |
| K894484 | AUDIOTESTER SCREENING AUDIOMETER | Prometex, Inc. | Jun 26, 1990 | SESE |
| K900096 | INTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA) | Artifical Hearing Systems Corp. | May 31, 1990 | SESE |
| K896710 | MIDIMATE 622 | Madsen North America, Inc. | Apr 13, 1990 | SESE |
| K896401 | MICROMATE 304 | Madsen North America, Inc. | Mar 27, 1990 | SESE |
| K896909 | MD5 AUTOMATIC AUDIOMETER | Singer Medical Products, Inc. | Mar 5, 1990 | SESE |
| K895310 | AUDIOMETER/MASTER HEARING AID, MAICO MODEL MF7 | Maico Hearing Instruments, Inc. | Jan 23, 1990 | SESE |
| K895200 | MODEL EB-22 NOISE STIK | Eckstein Brothers, Inc. | Jan 22, 1990 | SESE |
| K895785 | AUDIOMETER MODEL MD-4, MD-4P | Singer Medical Products, Inc. | Dec 5, 1989 | SESE |
| K895784 | IMPEDANCE ANALYZER/AUDIOMETER MODEL MD-3 | Singer Medical Products, Inc. | Dec 5, 1989 | SESE |
| K894748 | IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1P | Singer Medical Products, Inc. | Dec 5, 1989 | SESE |
| K891988 | AMPLAID A308 CLINICAL AUDIOMETER | Amplus Corp. | Oct 12, 1989 | SESE |
| K890993 | AUDIOMETER AI1, ME1 AND SA1 & MASTER HEARING AID | Maico Hearing Instruments, Inc. | Oct 12, 1989 | SESE |
| K883505 | BIOMETER AUDIOMETER | Micro Audiometrics Corp. | Aug 21, 1989 | SESE |
| K891373 | TRACOR RA500 AUDIOMETER | Tracor Instruments Austin, Inc. | Jul 14, 1989 | SESE |
| K890124 | ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER | Grason-Stadler, Inc. | Jul 14, 1989 | SESE |
| K890842 | 2400 AUDIOMETER, IMPEDANCE METER & HRNG. AID ANALY | Maico Hearing Instruments, Inc. | Jun 7, 1989 | SESE |
| K890497 | MODEL 20-P EXTENDED HIGH FREQUENCY AUDIOMETER | Monitor/Demlar | Jun 6, 1989 | SESE |
| K884218 | AUDIOSCOPE 3 MODEL 23300 ACCESSORIES | Welch Allyn, Inc. | Mar 10, 1989 | SESE |
| K884044 | AUDIOMETER DIGITAL HEARING SYSTEM | Resound Corp. | Feb 22, 1989 | SESE |
| K883169 | OTOMETER PORTABLE SCREENING AUDIOMETER | Otometer, Inc. | Dec 7, 1988 | SESE |
| K883478 | DIAGNOSTIC AUDIOMETER, MODEL MIDIMATE 602 | Madsen Electronics (Canada) , Ltd. | Nov 17, 1988 | SESE |
| K881760 | AE1162 CLINICAL/DIAGNOSTIC AUDIOMETER | American Electromedics Corp. | Jun 10, 1988 | SESE |
| K880059 | AMPLAID 309 CLINICAL AUDIOMETER | Amplus Corp. | Feb 23, 1988 | SESE |
| K875360 | THE BELTONE 2000 AUDIOMETER | Beltone Electronics Corp. | Feb 17, 1988 | SESE |
| K874516 | MODEL V4 AUDIOMETER | Digital Hearing Systems Corp. | Dec 14, 1987 | SESE |
| K872042 | PLAYTONE AUDIOMETER | Sensory Aids Corp. | Aug 11, 1987 | SESE |
| K863984 | MODEL 320 TWO CHANNEL AUDIOMETER | Virtual Corp. | Nov 18, 1986 | SESE |
| K863979 | MICROSCREEN I HEARING TESTER | Microscreen | Nov 18, 1986 | SESE |
| K862592 | PHOENIX SYSTEM SEVEN. | Nicolet Biomedical Instruments | Sep 16, 1986 | SESE |
| K862770 | AUDIOMETER/MASTER HEARING AID MF6 | Maico Hearing Instruments, Inc. | Aug 15, 1986 | SESE |
| K854835 | DAHLBERG MODEL GF MICROPROCESSOR AUDIOMETER | Miracle-Ear/Dahlberg, Inc. | Mar 4, 1986 | SESE |
| K854534 | DIGITAL SCREENING AUDIOMETER DSA6214 | Madsen Electronics (Canada) , Ltd. | Feb 13, 1986 | SESE |
| K854125 | CRAIGWELL AID FITTING SYSTEM AFS | Craigwell Electronics, Ltd. | Jan 16, 1986 | SESE |
| K853919 | MA25 PORTABLE AUDIOMETER | Maico Hearing Instruments, Inc. | Dec 18, 1985 | SESE |
| K853245 | TRACOR MODEL RA600 MICROPROCESSOR AUDIOMETER | Tracor Instruments, Inc. | Oct 16, 1985 | SESE |
| K851392 | TRACOR 200 MICROPROCESSOR AUDIOMETER/TRACOR RA 200 | Tracor Instruments, Inc. | Jun 20, 1985 | SESE |
| K851015 | TA-20 AUTOMATIC INDUSTIRAL AUDIOMETER | Teledyne Avionics Div. of Teledyne | Jun 4, 1985 | SESE |
| K845050 | UP800 A UNIVERSAL PRINTER | Madsen Electronics (Canada) , Ltd. | May 29, 1985 | SESE |
| K844069 | TA-201 CLINICAL AUDIOMETER | Teledyne Avionics Div. of Teledyne | Dec 3, 1984 | SESE |
| K843618 | AUDIOMETER | Grason-Stadler, Inc. | Dec 3, 1984 | SESE |
| K841567 | AUDIOMETER MA728 | Maico Hearing Instruments, Inc. | Jun 27, 1984 | SESE |
| K841167 | DEMLAR SYS I COMPUTER BASED AUDIOMETER | Demlar Medical, Inc. | Jun 27, 1984 | SESE |
| K833883 | DIGITAL AUDIOMETER/HEARING AID 3100 | Frye Electronics, Inc. | Feb 21, 1984 | SESE |
| K831431 | AUDIOMETER MODEL-500 | Audimax | Jun 30, 1983 | SESE |
Top Applicants
- Maico Hearing Instruments, Inc. — 20 clearances
- Grason-Stadler, Inc. — 12 clearances
- Bio-Logic Systems Corp. — 9 clearances
- Tracor Instruments, Inc. — 7 clearances
- Otodynamics, Ltd. — 7 clearances
