Cleared Traditional

K926244 - WIDEX MODEL D8 (HEARING AID)

K926244 is an FDA 510(k) clearance for WIDEX MODEL D8 (HEARING AID), manufactured by Widex Hearing Aid Co., Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K926244 · Widex Hearing Aid Co., Inc. · Ear, Nose, Throat device
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Jan 1993
Decision
47d
Days
Class 1
Risk

K926244 is an FDA 510(k) clearance for the WIDEX MODEL D8 (HEARING AID). 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 January 27, 1993 after a review of 47 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

FDA 510(k) Submission Details - K926244

510(k) Number K926244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1992
Decision Date January 27, 1993
Days to Decision 47 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 90d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

ESD Device Classification - Class 1, General Controls

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 952
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K926244.
WIDEX MODEL D16
K926085 · Widex Hearing Aid Co., Inc. · Feb 1993
SOUNDCHOICE WITH VARIABLE SLOPE
K926476 · Bausch & Lomb, Inc. · Feb 1993
PHONAK PICONET 231-X
K930145 · Phonak, Inc. · Feb 1993
P54-0 BEHIND THE EAR HEARING AID
K924887 · Electone, Inc. · Nov 1992
P54 HEARING AID
K924888 · Electone, Inc. · Nov 1992
PHONAK PICO-FORTE PP-SC-2 BTE HEARING INSTRUMENT
K924911 · Phonak, Inc. · Nov 1992