# K153634: Wireless Earlens Light Driven Hearing Aid

- Pathway: 510(k) (Traditional)
- Applicant: Earlens Corporation
- Decided: Apr 6, 2016 after 110 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K182480: Earlens Contact Hearing Aid (2019), 0 descendants of its own

## Indications for use
The wireless Earlens Light Driven Hearing Aid (a.k.a. Earlens 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/K153634
Methodology: https://510kreport.com/methodology