Cleared Traditional

K030791 - ANMP (ACOUSTIC NEURO MODULATION PROTOCOL)

K030791 is an FDA 510(k) clearance for ANMP (ACOUSTIC NEURO MODULATION PROTOCOL), manufactured by Tinnitech, Ltd.. The device is a Class 2 Ear, Nose, Throat device with product code KLW cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K030791 · Tinnitech, Ltd. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
36d
Days
Class 2
Risk

K030791 is an FDA 510(k) clearance for the ANMP (ACOUSTIC NEURO MODULATION PROTOCOL). Classified as Masker, Tinnitus (product code KLW), Class II - Special Controls.

Submitted by Tinnitech, Ltd. (Sydney, AU). The FDA issued a Cleared decision on April 17, 2003 after a review of 36 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 Tinnitech, Ltd. devices

FDA 510(k) Submission Details - K030791

510(k) Number K030791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2003
Decision Date April 17, 2003
Days to Decision 36 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
53d faster than avg
Panel avg: 89d · This submission: 36d
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 22
Devices cleared under the same product code (KLW) and FDA review panel - the closest regulatory comparables to K030791.
Tinnitus Sound Generator Module
K181586 · GN Hearing A/S · Jul 2018
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
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