Data / Medical devices / United States / Intelligent Hearing Systems Corp.
Intelligent Hearing Systems Corp.: FDA-registered device maker in Miami, FL, United States, 13 510(k) clearances
Intelligent Hearing Systems Corp. is registered with the FDA (registration 1052723) in Miami, FL, United States. It lists 8 device types. The FDA files 13 510(k) clearances under its listings, the newest dated September 29, 2017. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1052723
- FEI number
- 1000113738
- Address
- 6860 Sw 81st St, Miami, FL, United States, 33143
- Owner or operator
- INTELLIGENT HEARING SYSTEMS (9000078)
- Roles
- Contract manufacturer, Manufacturer, Manufacturer for export, Specification developer
- First device listed
- July 8, 1992
- Registered through
- 2026
- Brand names listed
- Aria, EarHug, IVRA, Intelligent VRA, Lilly TM-Wick Electrode, MADSEN Capella2 DP/TE/DP+TE, Opti-Amp DC Powered, OptiAmp and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Amplifier, Physiological Signal | GWL | 2 | Manufacturer | accessdata.fda.gov |
| Audiometer | EWO | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Cable, Electrode | IKD | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Auditory, Evoked Response | GWJ | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Stimulator, Electrical, Evoked Response | GWF | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve | ETN | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Photic, Evoked Response | GWE | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 29, 2017 | K163326 | SmartEP | GWJ | Substantially Equivalent | Intelligent Hearing Systems | accessdata.fda.gov |
| July 7, 2009 | K090579 | SMARTSCREENER-PLUS2 | GWJ | Substantially Equivalent | Intelligent Hearing Systems | accessdata.fda.gov |
| February 28, 2008 | K073384 | SMART COUPLER, MODEL M015401 | GWJ | Substantially Equivalent | Intelligent Hearing Systems | accessdata.fda.gov |
| July 18, 2007 | K070608 | SMARTEP, MODEL M010000 | GWJ | Substantially Equivalent | Intelligent Hearing Systems | accessdata.fda.gov |
| December 11, 2006 | K063402 | WICK ELECTRODE, MODEL M019260 | GXY | Substantially Equivalent | Intelligent Hearing Systems | accessdata.fda.gov |
| June 23, 2006 | K061443 | SMART USBLITE, MODEL M011120 | GWJ | Substantially Equivalent | Intelligent Hearing Systems | accessdata.fda.gov |
| August 31, 2005 | K052060 | OPTI-AMP DC-POWERED | GWL | Substantially Equivalent | Intelligent Hearing Systems | accessdata.fda.gov |
| February 20, 2004 | K031051 | SMARTEP-ASSR, MODEL M811007 | GWJ | Substantially Equivalent | Intelligent Hearing Systems | accessdata.fda.gov |
| January 8, 2003 | K023859 | SMARTTROAE | EWO | Substantially Equivalent | Intelligent Hearing Systems | accessdata.fda.gov |
| February 3, 1997 | K964426 | SMARTOAE | EWO | Substantially Equivalent | Intelligent Hearing Systems | accessdata.fda.gov |
| January 10, 1992 | K914876 | OPTI-AMP | GWL | Substantially Equivalent | Intelligent Hearing Systems | accessdata.fda.gov |
| August 2, 1991 | K904926 | SMART-EP | GWJ | Substantially Equivalent | Intelligent Hearing Systems | accessdata.fda.gov |
| May 31, 1990 | K900096 | INTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA) | EWO | Substantially Equivalent | Artifical Hearing Systems Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 21, 2008 | 54168 | Not yet classified | Terminated | Intelligent Hearing Systems Corporation, SmartEP with Vestibular Evoked Myogenic Potentials Version 3.96. Model M811016 | This was a marketing correction mandated by the United States Food and Drug Administration (USFDA). USFDA notified Intelligent Hearing Systems that 501(k) premarket notification application must be submitted and cleared in order to market and sell devices with Vestibular Evoked Myogenic Potential (VEMP) specific functions. The Food and Drug Administration co | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Auditory, Evoked Response
- All makers of Audiometer
- All makers of Amplifier, Physiological Signal
- All makers of Cable, Electrode
- All makers of Stimulator, Photic, Evoked Response
- All makers of Stimulator, Nerve
Updated September 29, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.