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Sign in to claim this brandIntelligent Hearing Systems Corp.
United States·US-MF-000011473
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 6860 SW 81st Street, Miami, United States
- Website
- ihsys.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Edward Miskiel
- EUDAMED SRN
- US-MF-000011473
- FDA FEI Number
- 1000113738
- DUNS Number
- —
Catalogue (101)
Page 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| IHS Angle Adaptors with Tubes | M015453 | FDA UDI | Class II | Active |
| SEP 4 Channel Fiber Optic Cable Long (Power) | M013214S | FDA UDI | Class II | Active |
| MADSEN Capella2 TE | M016000B | FDA UDI | Class II | Active |
| Bone Vibrator Head Band | M014420 | FDA UDI | Class II | Active |
| IntelligentVRA Software | M815000 | FDA UDI | Class II | Active |
| 3-Electrode Lead Patient Cable | M010331 | FDA UDI | Class II | Active |
| SmartScreener-Plus2 AEP Module | M812001 | FDA UDI | Class II | Active |
| Screener Cart | M998920 | FDA UDI | Class II | Active |
| SEP 8 Channel Fiber Optic Cable Long (Power) | M013218S | FDA UDI | Class II | Active |
| Opti-Amp Power Transmitter - Multi Channel | M013020P | FDA UDI | Class II | Active |
| Electrical Stimulation Box | M014910 | FDA UDI | Class II | Active |
| Universal Smart Box | M011110 | FDA UDI | Class II | Active |
| SEP 6 Channel Fiber Optic Cable Long (Power) | M013216S | FDA UDI | Class II | Active |
| 6 Channel Y-Adaptor Lead | M013901F | FDA UDI | Class II | Active |
| USB Response Box | M031501 | FDA UDI | Class II | Active |
| Video VRA Wireless Reponse Box | M020111 | FDA UDI | Class II | Active |
| SEP 6 Channel Fiber Optic Cable (Power) | M013206S | FDA UDI | Class II | Active |
| Video VRA USB Response Box | M020102 | FDA UDI | Class II | Active |
| DD45-300 Headphones | M015053 | FDA UDI | Class II | Active |
| Bone Vibrator w/ Cable and Headband (B81) | M014404 | FDA UDI | Class II | Active |
| OPTI-AMP USB Box | M012300 | FDA UDI | Class II | Active |
| EarHug | M015401 | FDA UDI | Class II | Active |
| Headphones 300 Ohms | M015050 | FDA UDI | Class II | Active |
| EarHug Pack | M015402 | FDA UDI | Class II | Active |
| Manual VRA Response Box | M020300 | FDA UDI | Class II | Active |
| SmartDPOAE Software | M813000 | FDA UDI | Class II | Active |
| 4 Channel Y-Adaptor Lead | M013901D | FDA UDI | Class II | Active |
| Bone Vibrator Cable | M014410 | FDA UDI | Class II | Active |
| 5-Electrode Lead Patient Cable | M010332 | FDA UDI | Class II | Active |
| ER3C Insert Earphones | M015302 | FDA UDI | Class II | Active |
| SEP 1 Channel Fiber Optic Cable (Power) | M013210S | FDA UDI | Class II | Active |
| Bone Vibrator 300 Ohms | M014400 | FDA UDI | Class II | Active |
| SmartScreener-Plus2 Screener Launch | M812002 | FDA UDI | Class II | Active |
| Feedback Box | M025500D | FDA UDI | Class II | Active |
| OAE 10D Probe | M032103 | FDA UDI | Class II | Active |
| Lilly TM-Wick Electrode | M013910 | EUDAMEDFDA UDI | Class I | Active |
| Smart Coupler, Model M015401 | K073384 | FDA 510(k) | Class II | Active |
| Smart-Ep | K904926 | FDA 510(k) | Class II | Active |
| Smartscreener-Plus2 | K090579 | FDA 510(k) | Class II | Active |
| Opti-Amp | K914876 | FDA 510(k) | Class II | Active |
| Smartoae | K964426 | FDA 510(k) | Class II | Active |
| Opti-Amp Dc-Powered | K052060 | FDA 510(k) | Class II | Active |
| Wick Electrode, Model M019260 | K063402 | FDA 510(k) | Class II | Active |
| Smart-Screener (auditory) | K925648 | FDA 510(k) | Class II | Active |
| Smart Usblite, Model M011120 | K061443 | FDA 510(k) | Class II | Active |
| Smartep, Model M010000 | K070608 | FDA 510(k) | Class II | Active |
| SmartEP | K163326 | FDA 510(k) | Class II | Active |
| Smartep-Assr, Model M811007 | K031051 | FDA 510(k) | Class II | Active |
| Smarttroae | K023859 | FDA 510(k) | Class II | Active |
| MADSEN Capella2 | 8-04-15320 | EUDAMEDFDA UDI | Class IIa | Active |
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Oct 21, 2008 | Z-1704-2010 | — | terminated | 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 considers that the VEMP testing functions |