Cleared Abbreviated

K171243 - audifon Tinnitus-Module

K171243 is an FDA 510(k) clearance for audifon Tinnitus-Module, manufactured by Audiofon USA, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code KLW cleared through the Abbreviated 510(k) pathway after a 174-day FDA review.

K171243 · Audiofon USA, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
174d
Days
Class 2
Risk

K171243 is an FDA 510(k) clearance for the audifon Tinnitus-Module. Classified as Masker, Tinnitus (product code KLW), Class II - Special Controls.

Submitted by Audiofon USA, Inc. (Debary, US). The FDA issued a Cleared decision on October 19, 2017 after a review of 174 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Audiofon USA, Inc. devices

FDA 510(k) Submission Details - K171243

510(k) Number K171243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2017
Decision Date October 19, 2017
Days to Decision 174 days
Submission Type Abbreviated
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 89d · This submission: 174d
Pathway characteristics
Standards-based clearance path.

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 K171243.
Tinnitus Sound Generator Module
K193303 · GN Hearing A/S · Feb 2020
Tinnitus Sound Generator Module
K180495 · GN Hearing A/S · Nov 2018
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