Cleared Traditional

K133308 - TINNITUS SOUNDSUPPORT (FDA 510(k) Clearance)

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

K133308 · Oticon A/S · Ear, Nose, Throat device
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Mar 2014
Decision
141d
Days
Class 2
Risk

K133308 is an FDA 510(k) clearance for the TINNITUS SOUNDSUPPORT. Classified as Masker, Tinnitus (product code KLW), Class II - Special Controls.

Submitted by Oticon A/S (Smorum, DK). The FDA issued a Cleared decision on March 18, 2014 after a review of 141 days - within the typical 510(k) review window.

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 Oticon A/S devices

Submission Details

510(k) Number K133308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2013
Decision Date March 18, 2014
Days to Decision 141 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
52d slower than avg
Panel avg: 89d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 75
Devices cleared under the same product code (KLW) and FDA review panel - the closest regulatory comparables to K133308.
Peace N Quiet (0.7.0)
K233435 · Pnq Health · Feb 2024
Tinearity G1 (6103)
K223694 · Duearity AB · Jun 2023
Tinnitogram Signal Generator
K221168 · Goldenear Company, Inc. · Feb 2023
SilentCloud
K221125 · Aureliym GmbH · Jan 2023
Multiflex Tinnitus Technology
K201370 · Starkey Laboratories, Inc. · Jun 2020
Tinnitus Sound Generator Module
K193303 · GN Hearing A/S · Feb 2020