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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Earlens Corporation. It received FDA 510(k) clearance on 2016-04-06 under 510(k) 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. The listed applicant is Earlens Corporation. The 510(k) number is K153634.

When did Wireless Earlens Light Driven Hearing Aid receive FDA 510(k) clearance?

Wireless Earlens Light Driven Hearing Aid received FDA 510(k) clearance on 2016-04-06, under 510(k) number K153634.

Who is the listed applicant for Wireless Earlens Light Driven 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 Wireless Earlens Light Driven Hearing Aid?

The FDA product code for Wireless Earlens Light Driven Hearing Aid is PLK.

Related Clinical Trials

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.

NCT06309264Comparing Hearing Aid Fitting Methods in Blast-exposed VeteransRECRUITING

Related PubMed Literature

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.

PMID: 28005723Light-Driven Contact Hearing Aid for Broad-Spectrum Amplification: Safety and Effectiveness Pivotal Study.Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology (2017)

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.

K182480Earlens Contact Hearing Aid

Related Devices (Code: PLK)

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.

K182480Earlens Contact 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.

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