Cleared Traditional

K080955 - ZEN PROGRAM (MIND 440 HEARING AID)

K080955 is an FDA 510(k) clearance for ZEN PROGRAM (MIND 440 HEARING AID), manufactured by Widex Hearing Aid Co., Inc.. The device is a Class 2 Ear, Nose, Throat device with product code KLW cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K080955 · Widex Hearing Aid Co., Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
85d
Days
Class 2
Risk

K080955 is an FDA 510(k) clearance for the ZEN PROGRAM (MIND 440 HEARING AID). Classified as Masker, Tinnitus (product code KLW), Class II - Special Controls.

Submitted by Widex Hearing Aid Co., Inc. (Lisle, US). The FDA issued a Cleared decision on June 27, 2008 after a review of 85 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 Widex Hearing Aid Co., Inc. devices

FDA 510(k) Submission Details - K080955

510(k) Number K080955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2008
Decision Date June 27, 2008
Days to Decision 85 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
5d faster than avg
Panel avg: 90d · This submission: 85d
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 57
Devices cleared under the same product code (KLW) and FDA review panel - the closest regulatory comparables to K080955.
SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM
K111293 · Soundcure, Inc. · Aug 2011
IE-ZEN (IN CLEAR SERIES HEARING AID)
K110973 · Widex USA · May 2011
TINNITUS SOUND GENERATOR MODULE
K110932 · Gn Resound A/S · May 2011
TINNITUS SOUND GENERATOR MODULE
K073636 · Gn Resound A/S · Mar 2008
CUSTOMIZED SOUND THERAPY (CST)
K070599 · Tinnitus Otosound Products, LLC · Jul 2007
THE INHIBITOR, MODEL 001
K070648 · Melmedtronics, Inc. · Jun 2007