Cleared Traditional

K965218 - SENSO DIGITAL (C18)

K965218 is an FDA 510(k) clearance for SENSO DIGITAL (C18), 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 25-day FDA review.

K965218 · Widex Hearing Aid Co., Inc. · Ear, Nose, Throat device
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Jan 1997
Decision
25d
Days
Class 1
Risk

K965218 is an FDA 510(k) clearance for the SENSO DIGITAL (C18). 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 24, 1997 after a review of 25 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 - K965218

510(k) Number K965218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1996
Decision Date January 24, 1997
Days to Decision 25 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
65d faster than avg
Panel avg: 90d · This submission: 25d
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 K965218.
AUDIOTONE (A-552)
K965063 · Miracle-Ear, Inc. · Jan 1997
COMFORTAID HEARING AID
K964680 · Ethical Hearing Instruments · Jan 1997
M11 SERIES: M11, M11M
K965088 · Philips Hearing Instruments Co. · Jan 1997
TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II
K964639 · Telex Communications, Inc. · Jan 1997
AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR
K964816 · Audina Hearing Instrument · Jan 1997
MIRACLE-EAR OR AUDIOTONE
K964669 · Miracle-Ear, Inc. · Dec 1996