Cleared Traditional

K792389 - WIDEX HEARING AID MODEL S10

K792389 is the FDA 510(k) clearance for WIDEX HEARING AID MODEL S10 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 58-day FDA review.

K792389 · Widex Hearing Aid Co., Inc. · Ear, Nose, Throat device
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Jan 1980
Decision
58d
Days
Class 1
Risk

K792389 is an FDA 510(k) clearance for the WIDEX HEARING AID MODEL S10. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Widex Hearing Aid Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on January 23, 1980 after a review of 58 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 K792389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1979
Decision Date January 23, 1980
Days to Decision 58 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
31d faster than avg
Panel avg: 89d · This submission: 58d
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 612
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K792389.
OTICON MODEL E19VF EARETTE HEARING AID
K800316 · Oticon Corp. · Feb 1980
RIONET HEARING AID HE-71
K800011 · Rion Acoustic Instruments, Inc. · Jan 1980
RIONET HEARING AID HA-61
K800012 · Rion Acoustic Instruments, Inc. · Jan 1980
WIDEX HEARING AID MODEL 820
K792567 · Widex Hearing Aid Co., Inc. · Jan 1980
HEARING AID, MODELS DRI-35/DL1-35
K792643 · Unitron Industries, Inc. · Jan 1980
MODEL 339 TELECROS WIRELESS BICROS
K792462 · Telex Communications, Inc. · Jan 1980