FDA 510(k)

Earlens Contact Hearing Aid

K-Number: K182480 · 2019-01-25

Decision Date2019-01-25

Product CodePLK

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

Earlens Contact Hearing Aid is the device name listed in this FDA 510(k) record. The listed applicant is Earlens Corporation. It received FDA 510(k) clearance on 2019-01-25 under 510(k) number K182480. The device is classified under product code PLK. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Earlens Contact Hearing Aid?

Earlens Contact Hearing Aid is a medical device that received FDA 510(k) clearance on 2019-01-25. The listed applicant is Earlens Corporation. The 510(k) number is K182480.

When did Earlens Contact Hearing Aid receive FDA 510(k) clearance?

Earlens Contact Hearing Aid received FDA 510(k) clearance on 2019-01-25, under 510(k) number K182480.

Who is the listed applicant for Earlens Contact Hearing Aid?

The FDA 510(k) record lists Earlens Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Earlens Contact Hearing Aid?

The FDA product code for Earlens Contact Hearing Aid is PLK.

Other records listing Earlens Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K153634Wireless Earlens Light Driven Hearing Aid

Related Devices (Code: PLK)

K153634Wireless Earlens Light Driven Hearing AidEarlens Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.