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Earlens Light Driven Hearing Aid, Binaural

EARLENS CORPORATION · Model BKEL1 · UDI-DI 08500130070123

PLK Prescription
3
510(k) clearances
3
Adverse events
0
Recalls
1
Facilities

Description

Kit containing Left and Right Light Tip & Processor Assemblies Left and Right Tympanic Lens Charger Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black, BE - Beige, BR - Brown

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.