Cleared Traditional

K073636 - TINNITUS SOUND GENERATOR MODULE (FDA 510(k) Clearance)

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

K073636 · Gn Resound A/S · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Mar 2008
Decision
78d
Days
Class 2
Risk

K073636 is an FDA 510(k) clearance for the TINNITUS SOUND GENERATOR MODULE. Classified as Masker, Tinnitus (product code KLW), Class II - Special Controls.

Submitted by Gn Resound A/S (Ballerup, DK). The FDA issued a Cleared decision on March 13, 2008 after a review of 78 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gn Resound A/S devices

Submission Details

510(k) Number K073636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2007
Decision Date March 13, 2008
Days to Decision 78 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
11d faster than avg
Panel avg: 89d · This submission: 78d
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 K073636.
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