510(k) · Cleared
ClearediHearTest
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ihear Medical, Inc. · EWO Audiometer
Cleared on Dec 29, 2015 as substantially equivalent to K982878 (Micro Audiometrics Corp., 1998) and 1 other predicate after a 257-day review. Its family tree reaches back 3 generations to 1985.
- Decided
- Dec 29, 2015
- Review
- 257 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K850123 (1985). 9 ancestors in all, the oldest K812529 (1981). No later device cites it as a predicate yet.
- Root · 3 generations backK850123 IN-TH-Ear Hearing AidGeneral Hearing Instruments, Inc. · 1985
- 2 generations backK964603 Articular Hearing AidsDecibel Instruments, Inc. · 1996
- 1 generation backK021867 Insound XT Series Hearing AidInsound Medical, Inc. · 2002
- This deviceK151025 iHearTestIhear Medical, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K850123 | IN-TH-Ear Hearing Aid | General Hearing Instruments, Inc. | 1985 | — |
| −2 | K964603 | Articular Hearing Aids | Decibel Instruments, Inc. | 1996 | — |
| −1 | K021867 | Insound XT Series Hearing Aid | Insound Medical, Inc. | 2002 | — |
| 0 (this device) | K151025 | iHearTest | Ihear Medical, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 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 9.3 · 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? (3)
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 |
|---|---|---|---|
| * | K982878 | Earscan 3Summary page 4…Predicate Devices: 1. Maico MA1 Handheld Audiometer, (Establishment # 2113281) Maico Diagnostics, Exempt under 21 CFR §874.1050 2. Earscan 3 Screening Audiometer (K 982878) Micro Audiometric Corp.; approved for marketing on November 3, 1998 3. InSound HandFit (K 021867) InSound Medical, part of th… | 1998 |
| * | K021867 | Insound XT Series Hearing AidSummary page 4…Exempt under 21 CFR §874.1050 2. Earscan 3 Screening Audiometer (K 982878) Micro Audiometric Corp.; approved for marketing on November 3, 1998 3. InSound HandFit (K 021867) InSound Medical, part of the InSound XT Hearing Aid and HandFit system, approved for marketing on November 19, 2002… | 2002 |
| * | — | Maico MA1 Handheld Audiometer Named without a submission number |
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?
- The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 11.7 years on median.
- None of the 9 ancestors has a recall.
How does its category compare?
All EWO devicesEWO Audiometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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?
The iHearTest is an air-conduction over the counter hearing screener for profiling your hearing ability based on guidelines
by the World Health Organization (WHO). The iHearTest is intended for home use by adults of at least 18 years of age.
Hearing test results are displayed on the computer screen and stored in our HIPAA-compliant remote server for review
anytime using secure online access.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151025 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151025: iHearTest.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151025
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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