Cleared Traditional

K982432 - PILLOW MASKER, C2007M, C2008M,CE2000, WONDER EAR, MINI WONDER EAR, PT-2SM, PT-3SM, PT-3LFM, PT-3HFM, PT3CM, PT5-SM, PT5-

K982432 is an FDA 510(k) clearance for PILLOW MASKER, manufactured by Tinnitus Treatment Centers, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code KLW cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K982432 · Tinnitus Treatment Centers, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
196d
Days
Class 2
Risk

K982432 is an FDA 510(k) clearance for the PILLOW MASKER, C2007M, C2008M,CE2000, WONDER EAR, MINI WONDER EAR, PT-2SM, PT.... Classified as Masker, Tinnitus (product code KLW), Class II - Special Controls.

Submitted by Tinnitus Treatment Centers, Inc. (Dallas, US). The FDA issued a Cleared decision on January 25, 1999 after a review of 196 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 Tinnitus Treatment Centers, Inc. devices

FDA 510(k) Submission Details - K982432

510(k) Number K982432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1998
Decision Date January 25, 1999
Days to Decision 196 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
106d slower than avg
Panel avg: 90d · This submission: 196d
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 65
Devices cleared under the same product code (KLW) and FDA review panel - the closest regulatory comparables to K982432.
CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
K011366 · Siemens Hearing Instruments, Inc. · Jun 2001
TCI (TINNITUS CONTROL INSTRUMENT)
K003559 · Siemens Hearing Instruments, Inc. · Apr 2001
TTCGHI-T AND TTCTN3-T-T
K982451 · Tinnitus Treatment Centers, Inc. · May 1999
TELEX TINNITUS-COMPANION
K984243 · Telex Communications, Inc. · Jan 1999
AUREX-3
K981704 · Adm Tronics Unltd, Inc. · Aug 1998
DIGITAL TINNITUS MASKING SYSTEM
K974501 · Petroff Audio Technologies · Jan 1998