FDA Device Intelligence
Home › EARLENS CORPORATION › Earlens Contact Hearing Solution, Monaural, Right

Earlens Contact Hearing Solution, Monaural, Right

EARLENS CORPORATION · Model IK01R · UDI-DI 00850013007271

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

Description

Inductive Kit containing Right Ear Tip & Processor Assembly, Right Tympanic Lens, Charger. Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black,

Query this across every FDA database — by API.

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

Get your free API keyRead the docs
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.