Cleared Traditional

K151558 - Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro 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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 90d · 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 Consultant

Deborah L. Sheffield Consulting
DEBORAH SHEFFIELD

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KLW Masker, Tinnitus

All 60
Devices cleared under the same product code (KLW) and FDA review panel - the closest regulatory comparables to K151558.
TinniLogic Mobile Tinnitus Management Device
K163094 · Jiangsu Betterlife Medical Co., Ltd. · May 2017
Sound Options Tinnitus Treatment
K161562 · Sound Options Tinnitus Treatments, Inc. · Sep 2016
HyperSound Tinnitus Module
K161331 · Turtle Beach Corporation · Aug 2016
REVE134
K151719 · Kw Ear Lab, Inc. · Oct 2015
Serenity
K150014 · Sanuthera, Inc. · Jul 2015
Tinnitus Sound Generator Module
K150171 · Gn Resound A/S · May 2015