# DEN150002: EarLens Contact Hearing Device

- Pathway: De Novo (Direct)
- Applicant: Earlens Corporation
- Decided: Sep 29, 2015 after 270 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
EarLens™ Contact Hearing Device 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/DEN150002
Methodology: https://510kreport.com/methodology