Cleared Traditional

K901316 - WIDEX MODEL Q9

K901316 is the FDA 510(k) clearance for WIDEX MODEL Q9 by Widex Hearing Aid Co., Inc.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K901316 · Widex Hearing Aid Co., Inc. · Ear, Nose, Throat device
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Apr 1990
Decision
20d
Days
Class 1
Risk

K901316 is an FDA 510(k) clearance for the WIDEX MODEL Q9, BTE W/QUATRO REMOTE CONTROL. 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 April 10, 1990 after a review of 20 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

Submission Details

510(k) Number K901316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1990
Decision Date April 10, 1990
Days to Decision 20 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 89d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 600
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K901316.
DAHLBERG MODEL JM IN-THE-EAR HEARING INSTRUMENT
K900862 · Miracle-Ear, Inc. · Apr 1990
SEARS MODEL LS9093 IN-THE-EAR HEARING INSTRUMENT
K901386 · Miracle-Ear, Inc. · Apr 1990
OTICON BTE HEARING AID (BEHIND-THE-EAR), MODEL E44
K901292 · Oticon Corp. · Apr 1990
WIDEX MODEL Q12 BTE WITH QUATRO REMOTE CONTROL
K901317 · Widex Hearing Aid Co., Inc. · Apr 1990
DAHLBERG MODEL JH IN-THE-EAR HEARING INSTRUMENT
K900861 · Miracle-Ear, Inc. · Apr 1990
WIDEX HEARING AID MODELS ES9T AND ES9H
K895981 · Widex Hearing Aid Co., Inc. · Mar 1990