Cleared Traditional

K013253 - HISONIC-TRD TINNITUS RELIEF DEVICE

K013253 is an FDA 510(k) clearance for HISONIC-TRD TINNITUS RELIEF DEVICE, manufactured by Hearing Innovations, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code KLW cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K013253 · Hearing Innovations, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
189d
Days
Class 2
Risk

K013253 is an FDA 510(k) clearance for the HISONIC-TRD TINNITUS RELIEF DEVICE. Classified as Masker, Tinnitus (product code KLW), Class II - Special Controls.

Submitted by Hearing Innovations, Inc. (Washington, D.C., US). The FDA issued a Cleared decision on April 5, 2002 after a review of 189 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3400 - 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.

View all Hearing Innovations, Inc. devices

FDA 510(k) Submission Details - K013253

510(k) Number K013253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2001
Decision Date April 05, 2002
Days to Decision 189 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
100d slower than avg
Panel avg: 89d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLW Device Classification - Class 2, Special Controls

Product Code KLW Masker, Tinnitus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3400
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.

Regulatory Peers - KLW Masker, Tinnitus

All 22
Devices cleared under the same product code (KLW) and FDA review panel - the closest regulatory comparables to K013253.
Tinnitus Sound Generator Module
K181586 · GN Hearing A/S · Jul 2018
ZEN PROGRAM (MIND 440 HEARING AID)
K080955 · Widex Hearing Aid Co., Inc. · Jun 2008
CRESCENT TINNITUS RETAINING SOUND GENERATOR
K030180 · Starkey Laboratories, Inc. · Sep 2003
CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)
K011364 · Siemens Hearing Instruments, Inc. · Jun 2001
CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
K011366 · Siemens Hearing Instruments, Inc. · Jun 2001
TCI (TINNITUS CONTROL INSTRUMENT)
K003559 · Siemens Hearing Instruments, Inc. · Apr 2001