Cleared Traditional

K970904 - WIDEX SENSO DIGITAL (CIC)

K970904 is an FDA 510(k) clearance for WIDEX SENSO DIGITAL (CIC), 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 14-day FDA review.

K970904 · Widex Hearing Aid Co., Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
14d
Days
Class 1
Risk

K970904 is an FDA 510(k) clearance for the WIDEX SENSO DIGITAL (CIC). 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 March 26, 1997 after a review of 14 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 - K970904

510(k) Number K970904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1997
Decision Date March 26, 1997
Days to Decision 14 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
76d faster than avg
Panel avg: 90d · This submission: 14d
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 K970904.
AUDALLION II HEARING SYSTEM
K970215 · Resound Corp. · Mar 1997
MULTI-CHANNEL COMPRESSION BTE (SD)
K970262 · Miracle-Ear, Inc. · Mar 1997
REXTON MODEL 48 AND 49PP
K970537 · Rexton, Inc. · Mar 1997
WIDEX MODEL SENSO DIGITAL (C9)
K965254 · Widex Hearing Aid Co., Inc. · Mar 1997
ADAPTIVE COMPRESSION - CLASS D/ CLASS D AGCI
K970430 · Midwest City Hearing Aid Center · Mar 1997
AHS OMEGA SP
K970057 · Authorized Hearing Systems, Inc. · Feb 1997