Cleared Traditional

K151558 - Desyncra for Tinnitus Therapy System

K151558 is an FDA 510(k) clearance for Desyncra for Tinnitus Therapy System, manufactured by Neurotherapies Reset GmbH. The device is a Class 2 Ear, Nose, Throat device with product code KLW cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K151558 · Neurotherapies Reset GmbH · Ear, Nose, Throat device
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Jan 2016
Decision
224d
Days
Class 2
Risk

K151558 is an FDA 510(k) clearance for the Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System. Classified as Masker, Tinnitus (product code KLW), Class II - Special Controls.

Submitted by Neurotherapies Reset GmbH (Juelich, DE). The FDA issued a Cleared decision on January 20, 2016 after a review of 224 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 Neurotherapies Reset GmbH devices

FDA 510(k) Submission Details - K151558

510(k) Number K151558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2015
Decision Date January 20, 2016
Days to Decision 224 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 89d · This submission: 224d
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 K151558.
Tinnitus Sound Generator Module
K193303 · GN Hearing A/S · Feb 2020
Tinnitus Sound Generator Module
K180495 · GN Hearing A/S · Nov 2018
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