| Integrity V500 (Integrity, Integrity with VEMP) (K242954) | Vivosonic, Inc. | 2024-12-19 |
| ALGO Pro Newborn Hearing Screener (ALGO Pro) (K233649) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2024-03-08 |
| QScreen (K220139) | Path Medical GmbH | 2022-08-03 |
| ALGO 7i (K211147) | Path Medical GmbH | 2021-10-14 |
| GSI Audera Pro (K193033) | Grason Stadler | 2020-04-24 |
| SmartEP (K163326) | Intelligent Hearing Systems | 2017-09-29 |
| Eclipse with VEMP (K162037) | Interacoustics A/S | 2017-03-23 |
| ICS CHARTR EP 200 WITH VEMP (K143670) | Gn Otometrics A/S | 2015-10-23 |
| ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER, (K141446) | Natus Medical Incorporated | 2014-08-22 |
| MADSEN ACCUSCREEN TYPE 1077 (K132957) | Gn Otometrics | 2014-02-27 |
| EARPROBE (K131141) | Path Medical GmbH | 2013-06-27 |
| HEARLAB ACA (K123701) | Frye Electronics, Inc. | 2013-04-05 |
| TYPE 1077 ACCUSCREEN (K122067) | Gn Otometrics | 2012-09-27 |
| CIRCUMAURAL ADHESIVE REPLACEMENT (K111555) | R & D Medical Products, Inc. | 2011-07-25 |
| TITAN (K103760) | Interacoustics A/S | 2011-05-05 |
| EARPROBE (K100661) | Path Medical GmbH | 2010-07-01 |
| ICS CHARTR EP 200 (K092373) | Gn Otometrics | 2009-09-03 |
| SMARTSCREENER-PLUS2 (K090579) | Intelligent Hearing Systems | 2009-07-07 |
| ICS CHARTR EP 200 (K083399) | Gn Otometrics A/S | 2009-02-20 |
| MAICO MB 11 WITH BERAPHONE PROBE (K082035) | Maico Diagnostics | 2009-01-29 |
| VIVOSONIC NEUROSCREEN (K080060) | Vivosonic, Inc. | 2008-04-04 |
| SMART COUPLER, MODEL M015401 (K073384) | Intelligent Hearing Systems | 2008-02-28 |
| BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM (K073626) | Bio-Logic Systems Corp. | 2008-02-05 |
| ALGO 5 NEWBORN HEARING SCREENER (K073665) | Natus Medical, Inc. | 2008-01-25 |
| SMARTEP, MODEL M010000 (K070608) | Intelligent Hearing Systems | 2007-07-18 |
| INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME) (K070696) | Interacoustics A/S | 2007-06-29 |
| SMART USBLITE, MODEL M011120 (K061443) | Intelligent Hearing Systems | 2006-06-23 |
| INTEGRITY, MODEL V500 (K043396) | Vivosonic, Inc. | 2005-01-24 |
| SMARTEP-ASSR, MODEL M811007 (K031051) | Intelligent Hearing Systems | 2004-02-20 |
| STACKED ABR FOR NAVIGATOR PRO (K030907) | Bio-Logic Systems Corp. | 2003-05-09 |
| MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM (K031009) | Bio-Logic Systems Corp. | 2003-04-28 |
| ALGO 3I NEWBORN HEARING SCREENER (K030823) | Natus Medical, Inc. | 2003-04-09 |
| BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM (K021895) | Bio-Logic Systems Corp. | 2002-07-01 |
| ECHO-SCREEN T, TA, TD, TDA, TC (K013977) | Fischer-Zoth Audiologic Systems, Inc. | 2002-06-14 |
| BIO-LOGIC ABAER CUB (K021215) | Bio-Logic Systems Corp. | 2002-05-15 |
| SABRE COMPAC (K011842) | Sle Limited | 2002-01-08 |
| AURIS AEP (K012415) | Synapsys, Inc. | 2001-12-18 |
| ALGO 3 NEWBORN HEARING SCREENER (K013137) | Natus Medical, Inc. | 2001-10-16 |
| MB 11 (K011746) | Maico Diagnostic GmbH | 2001-08-24 |
| ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS (K002985) | Ics Medical Corp. | 2000-12-13 |
| MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO. (K994149) | Bio-Logic Systems Corp. | 1999-12-27 |
| SABRE (K993177) | Sle Limited | 1999-11-16 |
| INTERACOUSTICS EP 15 ABR STAND ALONE UNIT (K991853) | Idem (Int'L Dist. of Electronics For Medicine) | 1999-10-25 |
| BIO-LOGIC EVOKED POTENTIAL FOR ABAER I (K992807) | Bio-Logic Systems Corp. | 1999-09-14 |
| EXCEL AV STIM 1000 (K972157) | Excel Tech. , Ltd. | 1998-01-30 |
| CHARTR EP (K960097) | Ics Medical Corp. | 1997-02-21 |
| TECA PREMIERE (K953732) | Medelec , Ltd. | 1995-10-19 |
| CLARITY SYSTEM II (K952080) | Sonamed Corp. | 1995-09-19 |
| ALGO-2 NEWBORN HEARING SCREENER (K936039) | Natus Medical, Inc. | 1995-01-05 |
| SMART-SCREENER (AUDITORY) (K925648) | Intelligent Hearing Systems | 1993-05-11 |
| MODEL 330 SCREENING AUDIO METER, MODIFIED (K926574) | Virtual Corp. | 1993-03-29 |
| DANTEC COUNTERPOINT MK2(TM) (K913957) | Dantec Medical, Inc. | 1992-01-30 |
| CORONET 100 (K913785) | Micro-Shev , Ltd. | 1991-12-31 |
| SMART-EP (K904926) | Intelligent Hearing Systems | 1991-08-02 |
| NICOLET MAPLELEAF SYSTEM (K905632) | Nicolet Instrument Corp. | 1991-06-07 |
| MICROSHEV MODEL 2000 (K874193) | Micro-Shev , Ltd. | 1988-03-21 |
| THE SCREENER GSI 55 ABR SCREENER (K870030) | Grason-Stadler, Inc. | 1987-03-13 |
| TECA/MEDELEC AS-10 SENSOR (K862906) | Teca, Inc. | 1987-02-04 |
| TECA/MEDELEC AUDIOSTAR (K863156) | Teca, Inc. | 1987-02-03 |
| EVOPORT 100 (K863985) | Jedmed Instrument Co. | 1987-01-29 |
| SIEGEN HEADPHONES (K862430) | Siegen Corp. | 1986-09-26 |
| 40-HZ AUDITORY EVOKED RESPONSE TEST (K862361) | Cadwell Laboratories, Inc. | 1986-09-17 |
| INSERT EARPHONES (K862363) | Cadwell Laboratories, Inc. | 1986-09-17 |
| ALGO I (K852687) | Algotek, Inc. | 1985-09-18 |
| EVOKED POTENTIALS SYSTEM MK10 (K832510) | Amplaid USA, Inc. | 1983-11-25 |
| MULTI-SIGNAL AUDITORY STIMULATOR SM700 (K830579) | Nicolet Biomedical Instruments | 1983-03-08 |
| AUDIOMETERS (VARIOUS MODELS) (K822177) | Kelleher Corp. | 1982-08-25 |
| TECA VISUAL/AUDIO STIMULATOR MODEL CS-2 (K813009) | Teca, Inc. | 1981-12-14 |
| MK6 ERA SYSTEM (K810473) | Amplaid USA, Inc. | 1981-04-29 |
| SYNAP-I INFANT SENSORY ASSESSMENT UNIT (K810138) | Infant Hearing Assessment Foundation | 1981-04-03 |
| MODEL S10CTCM AUDITORY STIMULATOR (K810539) | Grass Instrument Co. | 1981-03-17 |
| C-ERA-100 COMPUTERIZED ELECTRIC RESPON (K792085) | Micro-Shev , Ltd. | 1979-10-30 |
| AMPLAID MARK 4 AND MARK 5 (K781667) | Amplaid USA, Inc. | 1978-11-03 |
| ELECTRIC RESPONSE AUDIOMETER (K780540) | Life-Tech Instruments, Inc. | 1978-04-21 |
| SIGNAL PROCESSOR/AVERAGER MODEL 7S11 (K770878) | Medical Systems Corp. | 1977-06-01 |
| SYS. FOR REC. BSER RESPONSES (K770268) | Life-Tech Instruments, Inc. | 1977-02-28 |