510(k) · Cleared
ClearedUnity 2 Hia & Probe ( for Use with Unity 2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Hearing Instruments, Inc. · ETW Calibrator, Hearing Aid / Earphone And Analysis Systems
Cleared on Jun 5, 2007 after an 11-day review. The FDA summary names no predicate by number. 1 later device descends from it.
- Decided
- Jun 5, 2007
- Review
- 11 days
- Class
- Class II
- Product code
- ETW
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK071462 Unity 2 Hia & Probe ( for Use with Unity 2)Siemens Hearing Instruments, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK103298 Acam 5 Audiometer SystemAcousticon GmbH · 2011
Most influential descendants
Showing 1 of 1 · See all- K103298Acam 5 Audiometer SystemAcousticon GmbH · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K071462 | Unity 2 Hia & Probe ( for Use with Unity 2) | Siemens Hearing Instruments, Inc. | 2007 | — |
| +1 | K103298 | Acam 5 Audiometer System | Acousticon GmbH | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 ETW? 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?
The FDA summary names no predicate by number.
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 |
|---|---|---|---|
| K103298 | Acam 5 Audiometer System | 2011 | 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, K103298 (Acousticon GmbH, 2011) has gone furthest, with 0 descendants of its own.
How does its category compare?
All ETW devicesETW Calibrator, Hearing Aid / Earphone And Analysis Systems: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · ETW
2in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · ETW
Too few ETW 510(k)s in any year since 2007 to give a median.
Recalls per year · ETW
No recall names ETW since 2007.
Adverse event reports per year · ETW
1in 2025
MAUDE reports naming product code ETW, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Unity 2 HIA and Probe are intended to be used as a system to: (1) perform Real Ear Measurement; (2) get an objective indication of the characteristics of a hearing aid; and (3) assist in the adjustment of hearing aids while in use by the patient. It is used by ENT-professionals and in clinics for hearing aid fitting.
This device can either be sold individually or together with other Unity 2 modules.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071462 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071462: Unity 2 Hia & Probe ( for Use with Unity 2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071462
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