Earlens Contact Hearing Aid
K-Number: K182480 · 2019-01-25
ApplicantEarlens Corporation
Decision Date2019-01-25
Product CodePLK
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
Earlens Contact Hearing Aid is a medical device manufactured by Earlens Corporation. It received FDA 510(k) clearance on 2019-01-25 under approval 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. It is manufactured by Earlens Corporation. The 510(k) number is K182480.
When was Earlens Contact Hearing Aid approved by the FDA?
Earlens Contact Hearing Aid received FDA 510(k) clearance on 2019-01-25, under approval number K182480.
What company makes Earlens Contact Hearing Aid?
Earlens Contact Hearing Aid is manufactured by Earlens Corporation.
What is the FDA product code for Earlens Contact Hearing Aid?
The FDA product code for Earlens Contact Hearing Aid is PLK.
Related PubMed Literature
Other Devices by Earlens Corporation
Related Devices (Code: PLK)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.