# K182480: Earlens Contact Hearing Aid

- Pathway: 510(k) (Traditional)
- Applicant: Earlens Corporation
- Decided: Jan 25, 2019 after 137 days
- Product code: PLK (Tympanic Membrane Direct Contact Hearing Aid)
- Device class: 2
- Regulation: 21 CFR 874.3315
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K153634 (2016). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153634: Wireless Earlens Light Driven Hearing Aid, Earlens Corporation (2016) Summary page 4.

## Indications for use
The Earlens Contact Hearing Aid transmits amplified sound by vibrating the eardrum through direct contact. It is indicated for individuals 18 years and older with a mild to severe sensorineural hearing impairment who can benefit from amplification. The device can provide the full spectrum of amplification that includes 125 Hz - 10,000 Hz.

Source page: https://510kreport.com/device/K182480
Methodology: https://510kreport.com/methodology