510(k) · Cleared
ClearedEarscan 3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro Audiometrics Corp. · EWO Audiometer
Cleared on Nov 3, 1998 as substantially equivalent to K812529 (Micro Audiometrics Corp., 1981) and 1 other predicate after an 81-day review. Its family tree reaches back 1 generation to 1981. 1 later device descends from it.
- Decided
- Nov 3, 1998
- Review
- 81 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K812529 (1981). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K151025iHearTestIhear Medical, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K812529 | Earscan | Micro Audiometrics Corp. | 1981 | — |
| 0 (this device) | K982878 | Earscan 3 | Micro Audiometrics Corp. | 1998 | — |
| +1 | K151025 | iHearTest | Ihear Medical, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
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 EWO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EWO device
- #1 K234095 OtoNova/OtoNova Proscore 9.4 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K812529 | EarscanSummary page 1…udiometer Common/Usual Name - Air Conduction, bone conduction, and speech audiometer Proprietary name - Earscan 3 Predicate Device: =~ Micro Audiometrics Corp. Earscan (K812529) Micro Audiometrics Corp. Earscan II (K812529) Decibel Instruments, Inc. ProDigit 2000 (K940999) Device Description, Intended Us… | 1981 |
| * | K940999 | Prodigit 2000Summary page 1…name - Earscan 3 Predicate Device: =~ Micro Audiometrics Corp. Earscan (K812529) Micro Audiometrics Corp. Earscan II (K812529) Decibel Instruments, Inc. ProDigit 2000 (K940999) Device Description, Intended Use & Effectiveness: The Earscan 3 is similar to and predicated upon the Micro Audiometrics Corp.… | 1994 |
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 |
|---|---|---|---|
| K151025 | iHearTest | 2015 | 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K151025 (Ihear Medical, Inc., 2015) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EWO devicesEWO Audiometer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EWO
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · EWO
173in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EWO
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EWO
13in 2025
MAUDE reports naming product code EWO, 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 | 5 | 69 | 0 | 1 |
| 2008 | 1 | — | 1 | 1 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 4 |
| 2011 | 3 | 151 | 0 | 2 |
| 2012 | 4 | 137 | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 4 | 173 | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 1 | — | 0 | 6 |
| 2023 | 1 | — | 4 | 3 |
| 2024 | 2 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 13 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Earscan 3 is a peripheral used with a computer that creates an air conduction, bone conduction and speech audiometer, as defined by the standards shown in the labeling of the About Screen and the Splash Screen of the Earscan 3 software.
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/K982878 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982878: Earscan 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982878
Report an extraction error
Are you the manufacturer?
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