Cleared Traditional

K901317 - WIDEX MODEL Q12 BTE WITH QUATRO REMOTE ...

K901317 is the FDA 510(k) clearance for WIDEX MODEL Q12 BTE WITH QUATRO REMOTE ... 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.

K901317 · Widex Hearing Aid Co., Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1990
Decision
20d
Days
Class 1
Risk

K901317 is an FDA 510(k) clearance for the WIDEX MODEL Q12 BTE WITH 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 K901317 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 K901317.
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 Q9, BTE W/QUATRO REMOTE CONTROL
K901316 · 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
WIDEX HEARING AID MODEL ES 10 ASP T
K895982 · Widex Hearing Aid Co., Inc. · Mar 1990