510(k) · Cleared
ClearedWireless Earlens Light Driven Hearing Aid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Earlens Corporation · PLK Tympanic Membrane Direct Contact Hearing Aid
Cleared on Apr 6, 2016 after a 110-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Apr 6, 2016
- Review
- 110 days
- Class
- Class II
- Product code
- PLK
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK153634 Wireless Earlens Light Driven Hearing AidEarlens Corporation · 2016
- Descendant · cites it directly · 0 of its ownK182480 Earlens Contact Hearing AidEarlens Corporation · 2019
Most influential descendants
Showing 1 of 1 · See all- K182480Earlens Contact Hearing AidEarlens Corporation · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K153634 | Wireless Earlens Light Driven Hearing Aid | Earlens Corporation | 2016 | — |
| +1 | K182480 | Earlens Contact Hearing Aid | Earlens Corporation | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PLK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182480 | Earlens Contact Hearing Aid | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K182480 (Earlens Corporation, 2019) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PLK devicesPLK Tympanic Membrane Direct Contact Hearing Aid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PLK
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · PLK
Too few PLK 510(k)s in any year since 2007 to give a median.
Recalls per year · PLK
No recall names PLK since 2007.
Adverse event reports per year · PLK
2in 2023
MAUDE reports naming product code PLK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K153634 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153634: Wireless Earlens Light Driven Hearing Aid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153634
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026