Cleared Traditional

K122028 - AURICAL HIT (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K122028 · Gn Otometrics · Ear, Nose, Throat device
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Oct 2012
Decision
105d
Days
Class 2
Risk

K122028 is an FDA 510(k) clearance for the AURICAL HIT. Classified as Calibrator, Hearing Aid / Earphone And Analysis Systems (product code ETW), Class II - Special Controls.

Submitted by Gn Otometrics (Naples, US). The FDA issued a Cleared decision on October 23, 2012 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3310 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K122028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2012
Decision Date October 23, 2012
Days to Decision 105 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 89d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ETW Calibrator, Hearing Aid / Earphone And Analysis Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3310
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.