Cleared Traditional

K912169 - WIDEX MODEL QX IN-THE-EAR HEARING AID

K912169 is an FDA 510(k) clearance for WIDEX MODEL QX IN-THE-EAR HEARING AID, manufactured by Widex Hearing Aid Co., Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K912169 · Widex Hearing Aid Co., Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1991
Decision
12d
Days
Class 1
Risk

K912169 is an FDA 510(k) clearance for the WIDEX MODEL QX IN-THE-EAR HEARING AID. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Widex Hearing Aid Co., Inc. (Long Island City, US). The FDA issued a Cleared decision on May 28, 1991 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3300 - 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 - K912169

510(k) Number K912169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1991
Decision Date May 28, 1991
Days to Decision 12 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 90d · This submission: 12d
Pathway characteristics
Predicate-based equivalence.

ESD Device Classification - Class 1, General Controls

Product Code ESD Hearing Aid, Air-conduction, Prescription
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.3300
Definition An Air-conduction Hearing Aid Is A Wearable Sound Amplifying Device Intended To Compensate For Impaired Hearing That Conducts Sound To The Ear Through The Air. This Is A Prescription Hearing Aid.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ESD Hearing Aid, Air-conduction, Prescription

All 952
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K912169.
QUILTONE MODEL 48 PP-AGC-I-D-BEHIND THE EAR
K912153 · Qualitone · Jun 1991
QUALITONE MODEL 48 C-WR-BEHIND THE EAR
K912154 · Qualitone · Jun 1991
PHILIPS M30 IN-THE-EAR HEARING AID
K912339 · Philips Hearing Instruments Co. · Jun 1991
CHAMPION, BEHIND-THE-EAR HEARING AID
K911705 · Electone, Inc. · May 1991
MODEL 800, BEHIND-THE-EAR HEARING AID
K911706 · Electone, Inc. · May 1991
REGAL, BEHIND-THE-EAR HEARING AID
K911707 · Electone, Inc. · May 1991