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Earlens Corporation

FDA Regulatory Profile

Earlens Corporation has 0 FDA recalls, 1 inspection, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 10, 2025 · NAI
Latest 510(k)
Jan 25, 2019

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances3Oct 4, 2026Not statedCurrent
Inspections1Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 10, 2025Menlo Park, CADevicesNo Action Indicated (NAI)3010863048

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K182480Earlens Contact Hearing AidJan 25, 2019
K153634Wireless Earlens Light Driven Hearing AidApr 6, 2016
DEN150002EarLens Contact Hearing DeviceSep 29, 2015

FDA data resources