510(k) · Cleared
ClearedAcam 5 Audiometer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acousticon GmbH · EWO Audiometer
Cleared on Apr 8, 2011 as substantially equivalent to K071462 (Siemens Hearing Instruments, Inc., 2007) after a 151-day review. Its family tree reaches back 1 generation to 2007.
- Decided
- Apr 8, 2011
- Review
- 151 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K071462 (2007). No later device cites it as a predicate yet.
- Root · 1 generation backK071462 Unity 2 Hia & Probe ( for Use with Unity 2)Siemens Hearing Instruments, Inc. · 2007
- This deviceK103298 Acam 5 Audiometer SystemAcousticon GmbH · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K071462 | Unity 2 Hia & Probe ( for Use with Unity 2) | Siemens Hearing Instruments, Inc. | 2007 | — |
| 0 (this device) | K103298 | Acam 5 Audiometer System | Acousticon GmbH | 2011 | — |
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? (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 |
|---|---|---|---|
| * | K071462 | Unity 2 Hia & Probe ( for Use with Unity 2)Summary page 1…EWO Subsequent Product Codes: ETW, ETS Predicate Device Information: *Siemens Unity 2 (K# unknown) and Siemens Unity 2 HIA and Probe, K071462 510(k) SUMMARY, continued Device Description ACAMO 5 isan audiometer with optional components for performing Rea… | 2007 |
| * | — | Siemens Unity 2 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?
- Its one ancestor has no recall.
How does its category compare?
All EWO devicesEWO Audiometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
ACAM® 5 is intended as an aid in diagnosing hearing loss and fitting of hearing aids. The device consists of an audiometer that can be used individually or with the other ACAM modules for performing Real Ear Measurements (REM), Hearing Instrument Test (HIT) and loudness scaling. ACAM 5® should be used by persons trained in audiology on patients of any age who are able to understand the basic principles of the test method when explained by the operator.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103298 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103298: Acam 5 Audiometer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103298
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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