Cleared Special

K110932 - TINNITUS SOUND GENERATOR MODULE

K110932 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 Special 510(k) pathway after a 29-day FDA review.

K110932 · Gn Resound A/S · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
29d
Days
Class 2
Risk

K110932 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 May 3, 2011 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Gn Resound A/S devices

FDA 510(k) Submission Details - K110932

510(k) Number K110932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2011
Decision Date May 03, 2011
Days to Decision 29 days
Submission Type Special
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
61d faster than avg
Panel avg: 90d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 K110932.
TINNITUS THERAPY SYSTEM ANM T30 CR
K112752 · Anm Adaptive Neuromodulation GmbH · Dec 2011
SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM
K111293 · Soundcure, Inc. · Aug 2011
IE-ZEN (IN CLEAR SERIES HEARING AID)
K110973 · Widex USA · May 2011
EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE
K093715 · Magnatone Hearing Aid Corp. Dba Persona Medical · Dec 2010
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