PLK · Class II · 21 CFR 874.3315

FDA Product Code PLK: Tympanic Membrane Direct Contact Hearing Aid

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.

Leading manufacturers include Earlens Corporation.

3
Total
2
Cleared
172d
Avg days
2015
Since

FDA 510(k) Cleared Tympanic Membrane Direct Contact Hearing Aid Devices (Product Code PLK)

3 devices
1–3 of 3
Cleared Jan 25, 2019
Earlens Contact Hearing Aid
K182480
Earlens Corporation
Ear, Nose, Throat · 137d
Cleared Apr 06, 2016
Wireless Earlens Light Driven Hearing Aid
K153634
Earlens Corporation
Ear, Nose, Throat · 110d
Not Cleared Sep 29, 2015
EarLens Contact Hearing Device
DEN150002
Earlens Corporation
Ear, Nose, Throat · 270d

About Product Code PLK - Regulatory Context