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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 1 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SEP 8 Channel Fiber Optic Cable (Power) | M013208S | FDA UDI | Class II | Active |
| Reusable Safety Snap Leads (3) | M013933 | FDA UDI | Class II | Active |
| eABR Cable | M013152 | FDA UDI | Class II | Active |
| Duet Response Box | M031501D | FDA UDI | Class II | Active |
| Reusable Safety Snap Lead | M013903 | FDA UDI | Class II | Active |
| SEP 1 Channel Fiber Optic Cable Long (Power) | M013211S | FDA UDI | Class II | Active |
| SmartEP-ASSR Software | M811007 | FDA UDI | Class II | Active |
| Smart USBLite | M011120 | FDA UDI | Class II | Active |
| SoundField USBBox-to-Amp Cable (Mono Plugs) | M025701 | FDA UDI | Class II | Active |
| SmartEP Software | M811000 | FDA UDI | Class II | Active |
| 4-Snap Lead Patient Cable | M010322 | FDA UDI | Class II | Active |
| EarHug Pack - No Electrodes | M015404 | FDA UDI | Class II | Active |
| 2 Channel Y-Adaptor Lead | M013901 | FDA UDI | Class II | Active |
| USBLite Standard Safety Electrode Connector Cable | M011122a | FDA UDI | Class II | Active |
| Screener Cart (TUV Listed) | M998920L | FDA UDI | Class II | Active |
| MADSEN Capella2 DP | M016000A | FDA UDI | Class II | Active |
| Opti-Amp Power Transmitter - 2 Channel | M013010P | FDA UDI | Class II | Active |
| SmartTrOAE Software | M814000 | FDA UDI | Class II | Active |
| USBLite Shielded Snap Electrode Lead | M011122b | FDA UDI | Class II | Active |
| Video VRA System Software | M020101 | FDA UDI | Class II | Active |
| ER3A Insert Earphones | M015300 | FDA UDI | Class II | Active |
| Opti-Amp Power Transmitter - 1 Channel | M013009P | FDA UDI | Class II | Active |
| USB to Electrical Stimulation Box Cable | M014911 | FDA UDI | Class II | Active |
| EarHug Adaptor with Tubes | M015451 | FDA UDI | Class II | Active |
| Manual VRA Master Control Box | M020201 | FDA UDI | Class II | Active |
| 8 Channel Y-Adaptor Lead | M013901H | FDA UDI | Class II | Active |
| SoundField USBBox-to-Amp Cable (RCA Plugs) | M025704 | FDA UDI | Class II | Active |
| 3-Snap Lead Patient Cable | M010321 | FDA UDI | Class II | Active |
| Reusable Safety Snap Leads (5) | M013953 | FDA UDI | Class II | Active |
| OAE 10D Probe | M032103G | FDA UDI | Class II | Active |
| USB IVRA Master Control Box | M025301 | FDA UDI | Class II | Active |
| SmartScreener-Plus2 OAE Module | M813010 | FDA UDI | Class II | Active |
| USBLite Cart Sound-Output-Electrode Box w 10D Grounded | M011202G | FDA UDI | Class II | Active |
| ER3C Insert Earphones for Solo | M015302S | FDA UDI | Class II | Active |
| Electrical Stimulator Probe | M014920 | FDA UDI | Class II | Active |
| Bone Vibrator Cable for USBLite | M014411 | FDA UDI | Class II | Active |
| EarHugs for AccuScreen | M015411 | FDA UDI | Class II | Active |
| USBLite Solo | M011140 | FDA UDI | Class II | Active |
| Aria | M011160 | FDA UDI | Class II | Active |
| SEP 2 Channel Fiber Optic Cable (Power) | M013200S | FDA UDI | Class II | Active |
| SmartAudiometer Software | M817000 | FDA UDI | Class II | Active |
| Toy Cabinet | M025400 | FDA UDI | Class II | Active |
| External Talk Through Microphone | M025550 | FDA UDI | Class II | Active |
| SEP 2 Channel Fiber Optic Cable Long (Power) | M013201S | FDA UDI | Class II | Active |
| Visual Stimulation Box | M014700 | FDA UDI | Class II | Active |
| Linked Electrode Adaptor | M013940 | FDA UDI | Class II | Active |
| Bone Vibrator Peidatric Head Band | M014430 | FDA UDI | Class II | Active |
| TM-Wick Electrode Cable | M013914 | FDA UDI | Class II | Active |
| Capella2 Starter Kit | 8-69-42800 | FDA UDI | Class II | Active |
| SEP 4 Channel Fiber Optic Cable (Power)) | M013204S | FDA UDI | Class II | 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 |