Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Audiometer

FDA product code EWO · 230 cleared devices

Class 2 Ear, Nose, Throat

Regulation: 21 CFR 874.1050
Review panel: EN
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-10-29 – 2024-06-21

EWO 1995-03-21

SCREENING AUDIOMETRY WORD RECOGNITION AUDIOMETRY

Applicant Calmed Technology, Inc.

K number K950888

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EWO 1995-02-08

GAME AUDIOMETERY WORD IDENTIFICATION AUDIOMETRY FOR USE WITH PRODIGIT(TM) 2000 PERSONAL DIGITAL AUDIOMETER(TM)

Applicant Calmed Technology, Inc.

K number K945689

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EWO 1995-02-02

VOYAGER 522

Applicant Madsen Electronics, Inc.

K number K945032

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EWO 1994-12-21

BIO-LOGIC EMAV EMISSION AVERAGING OTOACOUSTIC TEST

Applicant Bio-Logic Systems Corp.

K number K944735

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EWO 1994-09-16

INTERACOUSTICS CLINICAL AUDIOMETER

Applicant Precision Acoustics Ind., Inc.

K number K941920

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EWO 1994-09-02

AUDIO EXPERT AUDIOMETER

Applicant Beltone Electronics Corp.

K number K942716

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EWO 1994-08-24

INTERACOUSTICS COMPUTER AUDIOMETER BA 20

Applicant Precision Acoustics Ind., Inc.

K number K943066

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EWO 1994-08-19

KS 5 - CLINICAL AUDIOMETER

Applicant Maico Hearing Instruments, Inc.

K number K931322

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EWO 1994-08-17

INTERACOUSTICS CLINICAL AUDIOMETER

Applicant Precision Acoustics Ind., Inc.

K number K943065

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EWO 1994-07-29

BELTONE SERIES 100 AUDIOMETERS

Applicant Beltone Electronics Corp.

K number K940216

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EWO 1994-07-07

DAIL A HEARING SCREENING TEST

Applicant Occupational Hearing Services

K number K935719

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EWO 1994-06-20

INTERACOUSTICS DIAGNOSTIC AUDIOMETER

Applicant Precision Acoustics Ind., Inc.

K number K942006

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EWO 1994-05-10

MODEL 222 CLINICAL AUDIOMETER

Applicant Virtual Corp.

K number K934715

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EWO 1994-04-22

PRODIGIT 2000

Applicant Calmed Technology, Inc.

K number K940999

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EWO 1994-02-18

OTOACOUSTIC EMISSIONS UNIT CELESTA 503

Applicant Madsen Electronics (Canada) , Ltd.

K number K931325

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EWO 1994-02-09

ODYSSEY CLINICAL AUDIOMETER

Applicant Qualitone

K number K935348

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EWO 1994-02-01

GSI 60 DPOAE SYSTEM

Applicant Lucas Grason-Stadler, Inc.

K number K934658

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EWO 1994-01-24

SOUND SELECTOR FULL-SERVICE AUDIOMETER

Applicant Ensoniq Corp.

K number K933097

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EWO 1994-01-21

GLASER RT60, RT80, RT150 AUDIOMETER

Applicant Glaser Instruments AG

K number K934343

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EWO 1993-11-24

SELECTOR SL 01

Applicant Futuremed Div. of Future Impex Corp.

K number K933220

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EWO 1993-11-19

ORBITER 922 CLINICAL AUDIOMETER

Applicant Madsen Electronics (Canada) , Ltd.

K number K931324

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EWO 1993-11-01

AUDIOMETER DA 323

Applicant Futuremed Div. of Future Impex Corp.

K number K933222

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EWO 1993-09-29

CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT

Applicant Etymotic Research

K number K930553

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EWO 1993-08-05

MAICO MA790 AUDIOMETER

Applicant Maico Hearing Instruments, Inc.

K number K930112

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EWO 1993-08-05

MA25 - PORTABLE AUDIOMETER, MODIFICATION

Applicant Maico Hearing Instruments, Inc.

K number K926439

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EWO 1993-07-13

ACOUSTIC ANALYZER AA30

Applicant Precision Acoustics Ind., Inc.

K number K930260

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EWO 1993-06-18

TUBEPHONE MODELS ER-3A & ER-3 INSERT EARPHONES

Applicant Etymotic Research

K number K930003

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EWO 1993-03-04

AUDIOSCAN

Applicant Electrocaine Medical System

K number K926336

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EWO 1993-02-26

DSP SCREENING AUDIOMETER

Applicant Micro Audiometrics Corp.

K number K924543

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EWO 1993-02-26

AT-2

Applicant Qualitone

K number K923007

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EWO 1993-01-15

THE MONITOR MODEL MI-1.2.3 TONE COUNT SCREEN AUDIO

Applicant Monitor Instruments, Inc.

K number K922383

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EWO 1992-11-05

ST 20 PORTABLE AUDIOMETER

Applicant Maico Hearing Instruments, Inc.

K number K922746

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EWO 1992-09-23

DANPLEX SCREENING AUDIOMETER

Applicant Life-Tech Intl., Inc.

K number K923074

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EWO 1992-08-14

ACOUSTIC APPRAISE CD-3

Applicant Qualitone

K number K923013

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EWO 1992-05-15

PROGRAMMED AUDIOMETRIC DEVICE (PAD)/RECORS (PAR)

Applicant Hear-Well Technologies, Inc.

K number K921085

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EWO 1992-05-11

THE BELTONE AUDIO SCOUT

Applicant Beltone Electronics Corp.

K number K915323

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EWO 1992-01-31

ASRA, SCREENING AUDIOMETER

Applicant Mercury Electronics (Scot) , Ltd.

K number K914232

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EWO 1991-12-05

THE MONITOR/DEMLAR MODEL MI-5000 AUDIOMETER

Applicant Monitor Instruments, Inc.

K number K913356

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EWO 1991-11-05

EARSCAN DSP-1 PURE TONE AUDIOMETER

Applicant Micro Audiometrics Corp.

K number K913589

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EWO 1991-10-21

MICROTEK MEDICAL'S SOUND STIKS

Applicant Microbio-Medics, Inc.

K number K913276

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EWO 1991-10-21

MODEL 330 SCREENING AUDIOMETER

Applicant Virtual Corp.

K number K911689

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EWO 1991-10-11

TYPE FA10 AUDIOMETER

Applicant Frye Electronics, Inc.

K number K913221

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EWO 1991-09-17

HEARING CHECKER(TM), DESKTOP MODEL

Applicant Qualitone Hearing Aids and Audiometers

K number K904622

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EWO 1991-09-16

RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM

Applicant Resound Corp.

K number K912669

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EWO 1991-06-26

MAICO MA800 AUDIOMETER

Applicant Maico Hearing Instruments, Inc.

K number K911368

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EWO 1991-04-17

THE MAX SYSTEM, MODEL: BASIC, 1000,2000 AUDIOMETER

Applicant Sound Linked Data, Inc.

K number K900197

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EWO 1990-10-31

ACOUSTIC APPRAISER CD-2 AUDIOMETER/MASTER HEAR.AID

Applicant Qualitone

K number K904544

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EWO 1990-10-09

BIOLINK AUDIOMETER SOFTWARE ACCESSORY

Applicant Micro Audiometrics Corp.

K number K904270

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EWO 1990-09-19

OTOSCREENER-I AND OTO-SCREEN-I-P

Applicant Handtronix, Inc.

K number K903143

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EWO 1990-08-06

HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER

Applicant Starkey Laboratories, Inc.

K number K902068

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EWO 1990-07-13

GSI 17 SCREENING AUDIOMETER

Applicant Grason-Stadler, Inc.

K number K902540

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EWO 1990-06-26

AUDIOTESTER SCREENING AUDIOMETER

Applicant Prometex, Inc.

K number K894484

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EWO 1990-05-31

INTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA)

Applicant Artifical Hearing Systems Corp.

K number K900096

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EWO 1990-04-13

MIDIMATE 622

Applicant Madsen North America, Inc.

K number K896710

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EWO 1990-03-27

MICROMATE 304

Applicant Madsen North America, Inc.

K number K896401

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EWO 1990-03-05

MD5 AUTOMATIC AUDIOMETER

Applicant Singer Medical Products, Inc.

K number K896909

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EWO 1990-01-23

AUDIOMETER/MASTER HEARING AID, MAICO MODEL MF7

Applicant Maico Hearing Instruments, Inc.

K number K895310

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EWO 1990-01-22

MODEL EB-22 NOISE STIK

Applicant Eckstein Brothers, Inc.

K number K895200

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EWO 1989-12-05

AUDIOMETER MODEL MD-4, MD-4P

Applicant Singer Medical Products, Inc.

K number K895785

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EWO 1989-12-05

IMPEDANCE ANALYZER/AUDIOMETER MODEL MD-3

Applicant Singer Medical Products, Inc.

K number K895784

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EWO 1989-12-05

IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1P

Applicant Singer Medical Products, Inc.

K number K894748

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EWO 1989-10-12

AMPLAID A308 CLINICAL AUDIOMETER

Applicant Amplus Corp.

K number K891988

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EWO 1989-10-12

AUDIOMETER AI1, ME1 AND SA1 & MASTER HEARING AID

Applicant Maico Hearing Instruments, Inc.

K number K890993

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EWO 1989-08-21

BIOMETER AUDIOMETER

Applicant Micro Audiometrics Corp.

K number K883505

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EWO 1989-07-14

TRACOR RA500 AUDIOMETER

Applicant Tracor Instruments Austin, Inc.

K number K891373

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EWO 1989-07-14

ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER

Applicant Grason-Stadler, Inc.

K number K890124

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EWO 1989-06-07

2400 AUDIOMETER, IMPEDANCE METER & HRNG. AID ANALY

Applicant Maico Hearing Instruments, Inc.

K number K890842

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EWO 1989-06-06

MODEL 20-P EXTENDED HIGH FREQUENCY AUDIOMETER

Applicant Monitor/Demlar

K number K890497

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EWO 1989-03-10

AUDIOSCOPE 3 MODEL 23300 ACCESSORIES

Applicant Welch Allyn, Inc.

K number K884218

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EWO 1989-02-22

AUDIOMETER DIGITAL HEARING SYSTEM

Applicant Resound Corp.

K number K884044

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EWO 1988-12-07

OTOMETER PORTABLE SCREENING AUDIOMETER

Applicant Otometer, Inc.

K number K883169

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EWO 1988-11-17

DIAGNOSTIC AUDIOMETER, MODEL MIDIMATE 602

Applicant Madsen Electronics (Canada) , Ltd.

K number K883478

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EWO 1988-06-10

AE1162 CLINICAL/DIAGNOSTIC AUDIOMETER

Applicant American Electromedics Corp.

K number K881760

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EWO 1988-02-23

AMPLAID 309 CLINICAL AUDIOMETER

Applicant Amplus Corp.

K number K880059

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EWO 1988-02-17

THE BELTONE 2000 AUDIOMETER

Applicant Beltone Electronics Corp.

K number K875360

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EWO 1987-12-14

MODEL V4 AUDIOMETER

Applicant Digital Hearing Systems Corp.

K number K874516

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EWO 1987-08-11

PLAYTONE AUDIOMETER

Applicant Sensory Aids Corp.

K number K872042

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EWO 1986-11-18

MODEL 320 TWO CHANNEL AUDIOMETER

Applicant Virtual Corp.

K number K863984

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EWO 1986-11-18

MICROSCREEN I HEARING TESTER

Applicant Microscreen

K number K863979

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EWO 1986-09-16

PHOENIX SYSTEM SEVEN.

Applicant Nicolet Biomedical Instruments

K number K862592

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EWO 1986-08-15

AUDIOMETER/MASTER HEARING AID MF6

Applicant Maico Hearing Instruments, Inc.

K number K862770

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EWO 1986-03-04

DAHLBERG MODEL GF MICROPROCESSOR AUDIOMETER

Applicant Miracle-Ear/Dahlberg, Inc.

K number K854835

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EWO 1986-02-13

DIGITAL SCREENING AUDIOMETER DSA6214

Applicant Madsen Electronics (Canada) , Ltd.

K number K854534

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EWO 1986-01-16

CRAIGWELL AID FITTING SYSTEM AFS

Applicant Craigwell Electronics, Ltd.

K number K854125

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EWO 1985-12-18

MA25 PORTABLE AUDIOMETER

Applicant Maico Hearing Instruments, Inc.

K number K853919

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EWO 1985-10-16

TRACOR MODEL RA600 MICROPROCESSOR AUDIOMETER

Applicant Tracor Instruments, Inc.

K number K853245

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EWO 1985-06-20

TRACOR 200 MICROPROCESSOR AUDIOMETER/TRACOR RA 200

Applicant Tracor Instruments, Inc.

K number K851392

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EWO 1985-06-04

TA-20 AUTOMATIC INDUSTIRAL AUDIOMETER

Applicant Teledyne Avionics Div. of Teledyne

K number K851015

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EWO 1985-05-29

UP800 A UNIVERSAL PRINTER

Applicant Madsen Electronics (Canada) , Ltd.

K number K845050

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EWO 1984-12-03

TA-201 CLINICAL AUDIOMETER

Applicant Teledyne Avionics Div. of Teledyne

K number K844069

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EWO 1984-12-03

AUDIOMETER

Applicant Grason-Stadler, Inc.

K number K843618

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EWO 1984-06-27

AUDIOMETER MA728

Applicant Maico Hearing Instruments, Inc.

K number K841567

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EWO 1984-06-27

DEMLAR SYS I COMPUTER BASED AUDIOMETER

Applicant Demlar Medical, Inc.

K number K841167

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EWO 1984-02-21

DIGITAL AUDIOMETER/HEARING AID 3100

Applicant Frye Electronics, Inc.

K number K833883

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EWO 1983-06-30

AUDIOMETER MODEL-500

Applicant Audimax

K number K831431

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EWO 1983-02-07

AUDIT

Applicant Axonics, Inc.

K number K822335

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EWO 1983-01-05

ACOH WELLNESS TESTER

Applicant Occupational Health, Inc.

K number K823554

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EWO 1982-09-30

THE SCREENING TYMPANOMETER

Applicant American Electromedics Corp.

K number K822745

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EWO 1982-08-30

TRACOR RA400 AUDIOMETER

Applicant Tracor Instruments, Inc.

K number K822414

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EWO 1982-04-09

MIDDLE EAR ANALYZER (IMPEDANCE AUDIO

Applicant Grason-Stadler, Inc.

K number K820715

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