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Sign in to claim this brandEARLENS CORPORATION
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 1165 O'Brien Dr, Menlo Park, CA, 94025
- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
- 3010863048
- DUNS Number
- —
Catalogue (47)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Earlens Ear Tip | ET01X | FDA UDI | Class II | Unknown |
| Earlens Wireless Updater | EWU01 | FDA UDI | Class II | Unknown |
| Earlens Tympanic Lens | ITL01X | FDA UDI | Class II | Unknown |
| Earlens Light Driven Hearing Aid, Monaural, Right | MKEL1R | FDA UDI | Class II | Unknown |
| Earlens Processor | PREL1XX2 | FDA UDI | Class II | Unknown |
| Earlens Processor, Black | IPR01BL | FDA UDI | Class II | Active |
| Earlens Fitting Software, USB | ELF002 | FDA UDI | Class II | Unknown |
| Earlens Processor & Light Tip | PLEL1LR | FDA UDI | Class II | Unknown |
| Earlens Tympanic Lens | TLEL1X | FDA UDI | Class II | Unknown |
| Earlens Ear Tip, Binaural | ET01LR | FDA UDI | Class II | Active |
| Lateral Mixing Tips | IDT05 | FDA UDI | Class I | Active |
| Earlens Tympanic Lens, Binaural | ITL01LR | FDA UDI | Class II | Active |
| Earlens Ear Tip, Right | ET01R | FDA UDI | Class II | Active |
| Earlens Light Tip | LTEL1X | FDA UDI | Class II | Unknown |
| Soft Tipped Medial Mixing Tip(Blue) | IDT03 | FDA UDI | Class I | Unknown |
| Earlens Fidelity Software | ELF003 | FDA UDI | Class II | Active |
| Medial Impression Cartridges | IMC03 | FDA UDI | Class I | Active |
| Earlens Wireless Programmer | WPUSB01 | FDA UDI | Class II | Unknown |
| Earlens Light Driven Hearing Aid, Binaural | BKEL1 | FDA UDI | Class II | Unknown |
| Earlens Hybrid Impression Kit | HIK02 | FDA UDI | Class I | Active |
| Earlens Contact Hearing Solution, Monaural, Right | IK01R | FDA UDI | Class II | Active |
| Earlens Processor, Champagne | IPR01CH | FDA UDI | Class II | Active |
| Earlens Processor & Ear Tip | PET01X | FDA UDI | Class II | Unknown |
| Dispensing Tips (Blue) | IDT01 | FDA UDI | Class I | Unknown |
| Lateral Impression Cartridges | IMC04 | FDA UDI | Class I | Active |
| Earlens ELF USB | ELF001 | FDA UDI | Class II | Unknown |
| Impression Dispenser | IDG01 | FDA UDI | Class I | Active |
| Earlens Tympanic Lens, Right | ITL01R | FDA UDI | Class II | Active |
| Soft Medial Mixing Tips | IDT04 | FDA UDI | Class I | Active |
| Earlens Tympanic Lens, Left | ITL01L | FDA UDI | Class II | Active |
| Earlens Contact Hearing Solution, Binaural | IBK01 | FDA UDI | Class II | Active |
| Earlens Processor | PREL1XX | FDA UDI | Class II | Unknown |
| Earlens Ear Tip, Left | ET01L | FDA UDI | Class II | Active |
| Earlens Light Driven Hearing Aid, Monaural, Left | MKEL1L | FDA UDI | Class II | Unknown |
| Earlens Processor, Silver | IPR01SI | FDA UDI | Class II | Active |
| Earlens ELF USB | ELFW01 | FDA UDI | Class II | Unknown |
| Earlens Processor | IPR01XX | FDA UDI | Class II | Unknown |
| Earlens Processor & Light Tip | PLEL1X | FDA UDI | Class II | Unknown |
| Earlens Light Tip | LTEL1LR | FDA UDI | Class II | Unknown |
| Earlens Processor | IPR02XX | FDA UDI | Class II | Unknown |
| Earlens Contact Hearing Solution, Monaural, Left | IK01L | FDA UDI | Class II | Active |
| Earlens Charger | CHEL101 | FDA UDI | Class II | Active |
| Mixing Tips for 10ml Cartirdges | IDT02 | FDA UDI | Class I | Unknown |
| Earlens Tympanic Lens | TLEL1LR | FDA UDI | Class II | Unknown |
| Wireless Earlens Light Driven Hearing Aid | K153634 | FDA 510(k) | Class II | Active |
| EarLens Contact Hearing Device | DEN150002 | FDA 510(k) | Class II | Active |
| Earlens Contact Hearing Aid | K182480 | FDA 510(k) | Class II | Active |
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