Cleared Traditional

CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) (K011366) - FDA 510(k) Clearance

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

K011366 · Siemens Hearing Instruments, Inc. · Ear, Nose, Throat device
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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
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 75
Devices cleared under the same product code (KLW) and FDA review panel - the closest regulatory comparables to K011366.
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SilentCloud
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Multiflex Tinnitus Technology
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K193303 · GN Hearing A/S · Feb 2020