510(k) · Cleared
ClearedEarlens Contact 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 Jan 25, 2019 as substantially equivalent to K153634 (Earlens Corporation, 2016) after a 137-day review. Its family tree reaches back 1 generation to 2016.
- Decided
- Jan 25, 2019
- Review
- 137 days
- Class
- Class II
- Product code
- PLK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K153634 (2016). No later device cites it as a predicate yet.
- Root · 1 generation backK153634 Wireless Earlens Light Driven Hearing AidEarlens Corporation · 2016
- This deviceK182480 Earlens Contact Hearing AidEarlens Corporation · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K153634 | Wireless Earlens Light Driven Hearing Aid | Earlens Corporation | 2016 | — |
| 0 (this device) | K182480 | Earlens Contact Hearing Aid | Earlens Corporation | 2019 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K153634 | Wireless Earlens Light Driven Hearing AidSummary page 4…tact Hearing Aid DEVICE CLASSIFICATION: 21 CFR874.3315 PRODUCT CODE: PLK PREDICATE DEVICE: Wireless Earlens Light Driven Hearing Aid (K153634) DATE PREPARED: September 6, 2018 INTENDED USE: The Earlens Contact Hearing Aid is intended to compensate for imp… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
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. 2019, 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 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182480 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182480: Earlens Contact 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/K182480
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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