Earlens Contact Hearing Aid— 510(k) K182480

Name: FDA 510(k) clearance K182480
Creator: U.S. Food and Drug Administration
Published: 2019-01-25

Substantially Equivalent

Earlens Corporation

FDA 510(k) clearance K182480 for Earlens Contact Hearing Aid, Substantially Equivalent on 2019-01-25. Applicant: Earlens Corporation. Device class: 2.

Clearance details

Applicant: Earlens Corporation
Product code: Code PLK
Device class: Class 2
Regulation: 21 CFR 874.3315
Advisory panel: Ear, Nose, Throat
Date received: 2018-09-10
Decision date: 2019-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menlo Park, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PLK

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K153634 — Wireless Earlens Light Driven Hearing Aid2016-04-06
DEN150002 — EarLens Contact Hearing Device2015-09-29

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