Cleared Traditional

K884113 - HEARING AID WIDEX BTE

K884113 is the FDA 510(k) clearance for HEARING AID WIDEX BTE 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 81-day FDA review.

K884113 · Widex Hearing Aid Co., Inc. · Ear, Nose, Throat device
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Dec 1988
Decision
81d
Days
Class 1
Risk

K884113 is an FDA 510(k) clearance for the HEARING AID WIDEX BTE. 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 December 19, 1988 after a review of 81 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 K884113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1988
Decision Date December 19, 1988
Days to Decision 81 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
8d faster than avg
Panel avg: 89d · This submission: 81d
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 597
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K884113.
RESOUND HES, DIGITALLY PROGR., ITE HEARING AID
K884871 · Resound Corp. · Feb 1989
BTE HEARING AID SIEMENS MODEL 284PP-ASP
K884583 · Siemens Hearing Instruments, Inc. · Jan 1989
HEARING AID, UNITRON BTE MODEL UM60-AGC0
K884288 · Unitron Industries, Inc. · Jan 1989
ITE HEARING AID, SIEMENS MODEL 007, WITH TELOS
K882678 · Siemens Hearing Instruments, Inc. · Sep 1988
HEARING AID, UNITRON MODEL VISTA 1000
K883513 · Unitron Industries, Inc. · Sep 1988
MODEL P4/P4X BEHIND-THE-EAR HEARING AID W/PHOX
K882691 · Maico Hearing Instruments, Inc. · Aug 1988