510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K153634Substantially Equivalent

Wireless Earlens Light Driven Hearing Aid

Earlens Corporation, Menlo Park CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K153634 is the FDA 510(k) clearance record for Wireless Earlens Light Driven Hearing Aid, a class II device, cleared for Earlens Corporation on under FDA product code PLK (Tympanic Membrane Direct Contact Hearing Aid). FDA's definition for product code PLK reads: "A tympanic membrane contact hearing aid is intended to compensate for impaired hearing by transmitting amplified sound by vibrating the tympanic membrane through a transducer that is in direct contact with the tympanic membrane". FDA records list 3 510(k) clearances for Earlens Corporation, from to . As of , FDA records show no recalls naming K153634.

Clearance record

Decision date
Received
(110 days to decision)
Product code
PLK Tympanic Membrane Direct Contact Hearing Aid
Regulation
21 CFR 874.3315
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Earlens Corporation 4045-A Campbell Ave., Menlo Park CA
510(k) summary
Statement
Third party review
No

Clearances, product code PLK

Trailing 12 months

FDA records hold no clearances under product code PLK in the trailing twelve months.

FDA records show no clearances under product code PLK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PLK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260