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.

Total

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

About Product Code PLK - Regulatory Context

Related FDA 510(k) Regulatory Insights

What is a Predicate Device in FDA 510(k)?
What is an FDA Product Code?
What is 510(k) Clearance?
Browse all Ear, Nose, Throat FDA 510(k) clearances
FDA 510(k) regulatory consulting firms ranked by submission volume
FDA 510(k) submission cost and user fees FY 2026

Data Source

FDA 510(k) public files . 175,218 total devices indexed.

Latest clearance: Jan 25, 2019

Product Code Info

Code	PLK
Device class	Class II
CFR	21 CFR 874.3315
Panel	Ear, Nose, Throat

Verify on FDA.gov

View PLK classification on FDA.gov →