Wireless Earlens Light Driven Hearing Aid
K-Number: K153634 · 2016-04-06
ApplicantEarlens Corporation
Decision Date2016-04-06
Product CodePLK
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
Wireless Earlens Light Driven Hearing Aid is a medical device manufactured by Earlens Corporation. It received FDA 510(k) clearance on 2016-04-06 under approval number K153634. 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 Wireless Earlens Light Driven Hearing Aid?
Wireless Earlens Light Driven Hearing Aid is a medical device that received FDA 510(k) clearance on 2016-04-06. It is manufactured by Earlens Corporation. The 510(k) number is K153634.
When was Wireless Earlens Light Driven Hearing Aid approved by the FDA?
Wireless Earlens Light Driven Hearing Aid received FDA 510(k) clearance on 2016-04-06, under approval number K153634.
What company makes Wireless Earlens Light Driven Hearing Aid?
Wireless Earlens Light Driven Hearing Aid is manufactured by Earlens Corporation.
What is the FDA product code for Wireless Earlens Light Driven Hearing Aid?
The FDA product code for Wireless Earlens Light Driven Hearing Aid is PLK.
Related Clinical Trials
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.