Cleared Traditional

K073636 - TINNITUS SOUND GENERATOR MODULE

K073636 is an FDA 510(k) clearance for TINNITUS SOUND GENERATOR MODULE, manufactured by Gn Resound A/S. The device is a Class 2 Ear, Nose, Throat device with product code KLW cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K073636 · Gn Resound A/S · Ear, Nose, Throat device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K073636

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 90d · This submission: 78d
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 60
Devices cleared under the same product code (KLW) and FDA review panel - the closest regulatory comparables to K073636.
SWITCH TRT
K091552 · Audifon GmbH & Co. KG · Aug 2009
JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT
K083488 · Audifon-USA, Inc. · Feb 2009
ZEN PROGRAM (MIND 440 HEARING AID)
K080955 · Widex Hearing Aid Co., Inc. · Jun 2008
CUSTOMIZED SOUND THERAPY (CST)
K070599 · Tinnitus Otosound Products, LLC · Jul 2007
THE INHIBITOR, MODEL 001
K070648 · Melmedtronics, Inc. · Jun 2007
TRANQUIL TRI-BTE
K061459 · General Hearing Instruments, Inc. · Jun 2006