Stimulator, Auditory, Evoked Response
FDA product code GWJ · Class II (moderate risk) · 21 CFR 882.1900 · Neurology
76510(k) clearances
0PMA approvals
4recalls
Manufacturers
- Intelligent Hearing Systems 8
- Bio-Logic Systems Corp. 7
- Natus Medical Incorporated 5
- Path Medical GmbH 4
- Amplaid USA, Inc. 3
- Micro-Shev , Ltd. 3
- Vivosonic, Inc. 3
- Teca, Inc. 3
- Interacoustics A/S 3
- Gn Otometrics 3
- Cadwell Laboratories, Inc. 2
- Ics Medical Corp. 2
- Sle Limited 2
- Grason-Stadler, Inc. 2
- Life-Tech Instruments, Inc. 2
- Gn Otometrics A/S 2
- Jedmed Instrument Co. 1
- Siegen Corp. 1
- Algotek, Inc. 1
- Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242954 | Integrity V500 (Integrity, Integrity with VEMP)GWJ · Traditional | Vivosonic, Inc. | 12/19/2024SE |
| K233649 | ALGO Pro Newborn Hearing Screener (ALGO Pro)GWJ · Traditional | Natus Medical Incorporated Dba Excel-Tech Ltd.… | 03/08/2024SE |
| K220139 | QScreenGWJ · Traditional | Path Medical GmbH | 08/03/2022SE |
| K211147 | ALGO 7iGWJ · Traditional | Path Medical GmbH | 10/14/2021SE |
| K193033 | GSI Audera ProGWJ · Traditional | Grason Stadler | 04/24/2020SE |
| K163326 | SmartEPGWJ · Traditional | Intelligent Hearing Systems | 09/29/2017SE |
| K162037 | Eclipse with VEMPGWJ · Traditional | Interacoustics A/S | 03/23/2017SE |
| K143670 | Ics Chartr Ep 200 with VempGWJ · Traditional | Gn Otometrics A/S | 10/23/2015SE |
| K141446 | Echo-Screen III Pro Hearing Screener with Barcode Scanner, Echo-Screen III Pro Hearing…GWJ · Special | Natus Medical Incorporated | 08/22/2014SE |
| K132957 | Madsen Accuscreen Type 1077GWJ · Traditional | Gn Otometrics | 02/27/2014SE |
| K131141 | EarprobeGWJ · Traditional | Path Medical GmbH | 06/27/2013SE |
| K123701 | Hearlab AcaGWJ · Traditional | Frye Electronics, Inc. | 04/05/2013SE |
| K122067 | Type 1077 AccuscreenGWJ · Traditional | Gn Otometrics | 09/27/2012SE |
| K111555 | Circumaural Adhesive ReplacementGWJ · Traditional | R & D Medical Products, Inc. | 07/25/2011SE |
| K103760 | TitanGWJ · Traditional | Interacoustics A/S | 05/05/2011SE |
| K100661 | EarprobeGWJ · Traditional | Path Medical GmbH | 07/01/2010SE |
| K092373 | Ics Chartr Ep 200GWJ · Special | Gn Otometrics | 09/03/2009SE |
| K090579 | SMARTSCREENER-PLUS2GWJ · Traditional | Intelligent Hearing Systems | 07/07/2009SE |
| K083399 | Ics Chartr Ep 200GWJ · Traditional | Gn Otometrics A/S | 02/20/2009SE |
| K082035 | Maico MB 11 with Beraphone ProbeGWJ · Traditional | Maico Diagnostics | 01/29/2009SE |
| K080060 | Vivosonic NeuroscreenGWJ · Traditional | Vivosonic, Inc. | 04/04/2008SE |
| K073384 | Smart Coupler, Model M015401GWJ · Traditional | Intelligent Hearing Systems | 02/28/2008SE |
| K073626 | Bio-Logic Master II Evoked Response SystemGWJ · Special | Bio-Logic Systems Corp. | 02/05/2008SE |
| K073665 | Algo 5 Newborn Hearing ScreenerGWJ · Special | Natus Medical, Inc. | 01/25/2008SE |
| K070608 | Smartep, Model M010000GWJ · Traditional | Intelligent Hearing Systems | 07/18/2007SE |
| K070696 | Interacoustics Assr, Eclipse System (Cabinet Name)GWJ · Traditional | Interacoustics A/S | 06/29/2007SE |
| K061443 | Smart Usblite, Model M011120GWJ · Special | Intelligent Hearing Systems | 06/23/2006SE |
| K043396 | Integrity, Model V500GWJ · Traditional | Vivosonic, Inc. | 01/24/2005SE |
| K031051 | Smartep-Assr, Model M811007GWJ · Traditional | Intelligent Hearing Systems | 02/20/2004SE |
| K030907 | Stacked Abr for Navigator ProGWJ · Special | Bio-Logic Systems Corp. | 05/09/2003SE |
| K031009 | Modification to Bio-Logic Evoked Potential (Ep) SystemGWJ · Special | Bio-Logic Systems Corp. | 04/28/2003SE |
| K030823 | Algo 3I Newborn Hearing ScreenerGWJ · Special | Natus Medical, Inc. | 04/09/2003SE |
| K021895 | Bio-Logic Master Evoked Response SystemGWJ · Special | Bio-Logic Systems Corp. | 07/01/2002SE |
| K013977 | Echo-Screen T, Ta, TD, Tda, TCGWJ · Traditional | Fischer-Zoth Audiologic Systems, Inc. | 06/14/2002SE |
| K021215 | Bio-Logic Abaer CubGWJ · Special | Bio-Logic Systems Corp. | 05/15/2002SE |
| K011842 | Sabre CompacGWJ · Traditional | Sle Limited | 01/08/2002SE |
| K012415 | Auris AepGWJ · Traditional | Synapsys, Inc. | 12/18/2001SE |
| K013137 | Algo 3 Newborn Hearing ScreenerGWJ · Special | Natus Medical, Inc. | 10/16/2001SE |
| K011746 | MB 11GWJ · Traditional | Maico Diagnostic GmbH | 08/24/2001SE |
| K002985 | Ics Medical Chartr Ep and Chartr Oae SystemsGWJ · Traditional | Ics Medical Corp. | 12/13/2000SE |
| K994149 | Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro.GWJ · Special | Bio-Logic Systems Corp. | 12/27/1999SE |
| K993177 | SabreGWJ · Traditional | Sle Limited | 11/16/1999SE |
| K991853 | Interacoustics Ep 15 Abr Stand Alone UnitGWJ · Traditional | Idem (Int'L Dist. of Electronics For Medicine) | 10/25/1999SE |
| K992807 | Bio-Logic Evoked Potential for Abaer IGWJ · Special | Bio-Logic Systems Corp. | 09/14/1999SE |
| K972157 | Excel Av Stim 1000GWJ · Traditional | Excel Tech. , Ltd. | 01/30/1998SE |
| K960097 | Chartr EpGWJ · Traditional | Ics Medical Corp. | 02/21/1997SE |
| K953732 | Teca PremiereGWJ · Traditional | Medelec , Ltd. | 10/19/1995SE |
| K952080 | Clarity System IIGWJ · Traditional | Sonamed Corp. | 09/19/1995SE |
| K936039 | ALGO-2 Newborn Hearing ScreenerGWJ · Traditional | Natus Medical, Inc. | 01/05/1995SE |
| K925648 | Smart-Screener (Auditory)GWJ · Traditional | Intelligent Hearing Systems | 05/11/1993SE |
| K926574 | Model 330 Screening Audio Meter, ModifiedGWJ · Traditional | Virtual Corp. | 03/29/1993SE |
| K913957 | Dantec Counterpoint MK2(TM)GWJ · Traditional | Dantec Medical, Inc. | 01/30/1992SE |
| K913785 | Coronet 100GWJ · Traditional | Micro-Shev , Ltd. | 12/31/1991SE |
| K904926 | Smart-EpGWJ · Traditional | Intelligent Hearing Systems | 08/02/1991SE |
| K905632 | Nicolet Mapleleaf SystemGWJ · Traditional | Nicolet Instrument Corp. | 06/07/1991SE |
| K874193 | Microshev Model 2000GWJ · Traditional | Micro-Shev , Ltd. | 03/21/1988SE |
| K870030 | The Screener Gsi 55 Abr ScreenerGWJ · Traditional | Grason-Stadler, Inc. | 03/13/1987SE |
| K862906 | Teca/Medelec AS-10 SensorGWJ · Traditional | Teca, Inc. | 02/04/1987SE |
| K863156 | Teca/Medelec AudiostarGWJ · Traditional | Teca, Inc. | 02/03/1987SE |
| K863985 | Evoport 100GWJ · Traditional | Jedmed Instrument Co. | 01/29/1987SE |
| K862430 | Siegen HeadphonesGWJ · Traditional | Siegen Corp. | 09/26/1986SE |
| K862363 | Insert EarphonesGWJ · Traditional | Cadwell Laboratories, Inc. | 09/17/1986SE |
| K862361 | 40-HZ Auditory Evoked Response TestGWJ · Traditional | Cadwell Laboratories, Inc. | 09/17/1986SE |
| K852687 | Algo IGWJ · Traditional | Algotek, Inc. | 09/18/1985SE |
| K832510 | Evoked Potentials System MK10GWJ · Traditional | Amplaid USA, Inc. | 11/25/1983SE |
| K830579 | Multi-Signal Auditory Stimulator SM700GWJ · Traditional | Nicolet Biomedical Instruments | 03/08/1983SE |
| K822177 | Audiometers (Various Models)GWJ · Traditional | Kelleher Corp. | 08/25/1982SE |
| K813009 | Teca Visual/Audio Stimulator Model CS-2GWJ · Traditional | Teca, Inc. | 12/14/1981SE |
| K810473 | MK6 Era SystemGWJ · Traditional | Amplaid USA, Inc. | 04/29/1981SE |
| K810138 | Synap-I Infant Sensory Assessment UnitGWJ · Traditional | Infant Hearing Assessment Foundation | 04/03/1981SE |
| K810539 | Model S10CTCM Auditory StimulatorGWJ · Traditional | Grass Instrument Co. | 03/17/1981SE |
| K792085 | C-ERA-100 Computerized Electric ResponGWJ · Traditional | Micro-Shev , Ltd. | 10/30/1979SE |
| K781667 | Amplaid Mark 4 and Mark 5GWJ · Traditional | Amplaid USA, Inc. | 11/03/1978SE |
| K780540 | Electric Response AudiometerGWJ · Traditional | Life-Tech Instruments, Inc. | 04/21/1978SE |
| K770878 | Signal Processor/Averager Model 7S11GWJ · Traditional | Medical Systems Corp. | 06/01/1977SE |
| K770268 | Sys. for Rec. Bser ResponsesGWJ · Traditional | Life-Tech Instruments, Inc. | 02/28/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0940-2026 Class II | MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at… | Path | 11/06/2025Open, Classified |
| Z-0170-2020 Class II | The ICS CHARTR EP 200There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces… | GN Otometrics | 05/28/2019Terminated |
| Z-2165-2010 | SonaMed Clarity System II; evoked response auditory stimulator; SonaMed Corp., Waltham…There is insufficient evidence to support any claims for safety and efficacy on the SonaMed Clarity devices. | Natus Medical Inc | 06/04/2010Terminated |
| Z-1704-2010 | Intelligent Hearing Systems Corporation, SmartEP with Vestibular Evoked Myogenic…This was a marketing correction mandated by the United States Food and Drug Administration (USFDA). USFDA… | Intelligent Hearing Systems Corp. | 10/21/2008Terminated |