Cleared Traditional

K011366 - CUSTOM TCI-COMBI (TINNITUS CONTROL INST...

K011366 is the FDA 510(k) clearance for CUSTOM TCI-COMBI (TINNITUS CONTROL INST... by Siemens Hearing Instruments, Inc.. It is a Class 2 Ear, Nose, Throat device (product code KLW) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K011366 · Siemens Hearing Instruments, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
28d
Days
Class 2
Risk

K011366 is an FDA 510(k) clearance for the CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION). Classified as Masker, Tinnitus (product code KLW), Class II - Special Controls.

Submitted by Siemens Hearing Instruments, Inc. (Piscataway, US). The FDA issued a Cleared decision on June 1, 2001 after a review of 28 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 Siemens Hearing Instruments, Inc. devices

Submission Details

510(k) Number K011366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2001
Decision Date June 01, 2001
Days to Decision 28 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
61d faster than avg
Panel avg: 89d · This submission: 28d
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 21
Devices cleared under the same product code (KLW) and FDA review panel - the closest regulatory comparables to K011366.
ZEN PROGRAM (MIND 440 HEARING AID)
K080955 · Widex Hearing Aid Co., Inc. · Jun 2008
CRESCENT TINNITUS RETAINING SOUND GENERATOR
K030180 · Starkey Laboratories, Inc. · Sep 2003
CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)
K011364 · Siemens Hearing Instruments, Inc. · Jun 2001
TCI (TINNITUS CONTROL INSTRUMENT)
K003559 · Siemens Hearing Instruments, Inc. · Apr 2001
TELEX TINNITUS-COMPANION
K984243 · Telex Communications, Inc. · Jan 1999
STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER
K964216 · Starkey Laboratories, Inc. · Dec 1996