510(k) Report

510(k) · Cleared

Cleared

Aurical Hit

K122028510(k) TraditionalCleared Oct 23, 2012105-day reviewClass II21 CFR 874.3310

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Gn Otometrics · ETW Calibrator, Hearing Aid / Earphone And Analysis Systems

Cleared on Oct 23, 2012 as substantially equivalent to K113831 (Auditdata A/S, 2012) after a 105-day review. Its family tree reaches back 2 generations to 1995.

Decided
Oct 23, 2012
Review
105 days
Class
Class II
Product code
ETW
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K945199 (1995). No later device cites it as a predicate yet.

K945199 · RH2000 Real Ear Measurement System · Madsen Electronics, Inc. · 1995K113831 · Primus Hearing Instrument Test Unit · Auditdata A/S · 20121995200020052010
K113831 · Primus Hearing Instrument Test Unit · Auditdata A/S · 2012K945199 · RH2000 Real Ear Measurement System · Madsen Electronics, Inc. · 19950
  1. Root · 2 generations backK945199 RH2000 Real Ear Measurement SystemMadsen Electronics, Inc. · 1995
  2. 1 generation backK113831 Primus Hearing Instrument Test UnitAuditdata A/S · 2012
  3. This deviceK122028 Aurical HitGn Otometrics · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K945199RH2000 Real Ear Measurement SystemMadsen Electronics, Inc.1995—
−1K113831Primus Hearing Instrument Test UnitAuditdata A/S2012—
0 (this device)K122028Aurical HitGn Otometrics2012—
FIG. 1 — Lineage of K122028, 1995–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K113831Primus Hearing Instrument Test Unit
Summary page 2
…sting. Software validation and risk analysis was performed. 8. Substantial Equivalence Chart Characteristic Auditdata Primus K1 13831 ]Aurical HIT Type 1082 Intended Use: Hearing Aid Testing JHearing Aid…
Auditdata A/S2012—

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 17 years and passes through 3 companies; a new generation was cleared every 17.0 years on median.
  • None of the 2 ancestors has a recall.

How does its category compare?

All ETW devices

ETW Calibrator, Hearing Aid / Earphone And Analysis Systems: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · ETW

2in 2012

2007: 12009: 12011: 12012: 2
2007high 2 (2012) · low 0 (2008)2026

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

2019: 52020: 42021: 52022: 22024: 22025: 1
2007high 5 (2019) · low 0 (2007)2025

MAUDE reports naming product code ETW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—00
20091—00
20100—00
20111—00
20122—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—05
20200—04
20210—05
20220—02
20230—00
20240—02
20250—01
20260—0—

What is it indicated for?

The Aurical HIT Type 1082 is intended to be used by audiologists, technicians, and other professionals who perform hearing instrument testing. Used in conjunction with the OTOSuite software, the Type 1082 permits presentation of acoustic sounds and magnetic field stimuli in order to assess the audio processing and telecoil functionality of the hearing instrument.

Indications for use as stated in the FDA summary.

More from Gn Otometrics

8 FDA decisions under this applicant name. See the company

  • K161707Madsen ZodiacGn Otometrics · 2016
  • K151504ICS ImpulseGn Otometrics · 2015
  • K132957Madsen Accuscreen Type 1077Gn Otometrics · 2014
  • K122550Ics ImpulseGn Otometrics · 2013
  • K122067Type 1077 AccuscreenGn Otometrics · 2012

Recent decisions in ETW

The ETW category page

  • K113831Primus Hearing Instrument Test UnitAuditdata A/S · 2012
  • K110286GN Otometrics Type 1053 FreefitGn Otometrics A/S · 2011
  • K093006Fonix ,Model 8000Frye Electronics, Inc. · 2009
  • K071462Unity 2 Hia & Probe ( for Use with Unity 2)Siemens Hearing Instruments, Inc. · 2007
  • K061104Speechlink 100 Type 1053Gn Otometrics A/S · 2006

https://510kreport.com/device/K122028 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122028: Aurical Hit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122028

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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