Cleared Traditional

K897033 - WIDEX BTE HEARING AID MODEL Q16 WITH RE...

K897033 is the FDA 510(k) clearance for WIDEX BTE HEARING AID MODEL Q16 WITH RE... 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 156-day FDA review.

K897033 · Widex Hearing Aid Co., Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1990
Decision
156d
Days
Class 1
Risk

K897033 is an FDA 510(k) clearance for the WIDEX BTE HEARING AID MODEL Q16 WITH REMOTE. 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 23, 1990 after a review of 156 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Widex Hearing Aid Co., Inc. devices

Submission Details

510(k) Number K897033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1989
Decision Date May 23, 1990
Days to Decision 156 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
67d slower than avg
Panel avg: 89d · This submission: 156d
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 609
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K897033.
AUDIOTONE ITE HEARING AID MODEL ZD (XT)
K901746 · Miracle-Ear, Inc. · May 1990
AUDIOTONE ITE HEARING AID MODEL ZG (MIRAGE)
K901747 · Miracle-Ear, Inc. · May 1990
AUDIOTONE ITE HEARING AID MODEL ZA (MICRO)
K901783 · Miracle-Ear, Inc. · May 1990
MIRACLE EAR MODEL PC PROG. IN-THE-EAR HEARING AID
K897035 · Miracle-Ear, Inc. · May 1990
MODEL 366 HEARING AID
K900846 · Telex Communications, Inc. · May 1990
WIDEX HEARING AID MODEL THE DISCOVERY
K901642 · Widex Hearing Aid Co., Inc. · May 1990