Earlens Contact Hearing Aid

FDA 510(k)

Class II (US FDA 510(k))

510(k) K182480

Identifiers

510(k) Number: K182480 FDA 510(k)
FDA Product Code: PLK FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 874.3315 FDA 510(k)
Regulation Number: 874.3315 FDA 510(k)
Advisory Committee: Ear, Nose, Throat FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Earlens Contact Hearing Aid is a Tympanic Membrane Direct Contact Hearing Aid, which transmits sound vibrations through direct contact. It is designed to compensate for impaired hearing. The device is classified as a class 2 device and is regulated under the regulation number 874.3315.

The Earlens Contact Hearing Aid is supplied as a single device and is intended for use in adults with mild-to-severe sensorineural hearing loss. It provides amplification across a range of frequencies, from 125 Hz to 10,000 Hz, and is available with the product code PLK and k number K182480. The device has been cleared under the FDA 510(k) clearance type.

Frequently asked questions

What type of hearing loss is the Earlens Contact Hearing Aid designed for?

The Earlens Contact Hearing Aid is designed for adults with mild-to-severe sensorineural hearing loss, providing amplification across a range of frequencies.

How is the Earlens Contact Hearing Aid supplied?

The Earlens Contact Hearing Aid is supplied as a single device.

What is the frequency range of the Earlens Contact Hearing Aid?

The Earlens Contact Hearing Aid provides amplification across a range of frequencies, from 125 Hz to 10,000 Hz.

What is the regulatory classification of the Earlens Contact Hearing Aid?

The Earlens Contact Hearing Aid is classified as a class 2 device and is regulated under the regulation number 874.3315.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Contact Us — Earlens, Earlens, Earlens Contact Hearing Aid (K182480) — FDA 510(k) | Innolitics, Earlens Contact Hearing Solution Hearing Aid User Manual, EarLens Contact Hearing Device (DEN150002) — FDA 510 (k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K182480	Class II	Active

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Manufacturer

Manufacturer: Earlens Corporation

Sources (1)

FDA 510(k) K182480 24 fields · synced Sep 22, 2026