Cleared Traditional

K964683 - DIGIFOCUS ITE

K964683 is an FDA 510(k) clearance for DIGIFOCUS ITE, manufactured by Oticon, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K964683 · Oticon, Inc. · Ear, Nose, Throat device
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Dec 1996
Decision
20d
Days
Class 1
Risk

K964683 is an FDA 510(k) clearance for the DIGIFOCUS ITE. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Oticon, Inc. (Somerset, US). The FDA issued a Cleared decision on December 12, 1996 after a review of 20 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 Oticon, Inc. devices

FDA 510(k) Submission Details - K964683

510(k) Number K964683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1996
Decision Date December 12, 1996
Days to Decision 20 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 89d · This submission: 20d
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 740
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K964683.
TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II
K964639 · Telex Communications, Inc. · Jan 1997
MIRACLE-EAR OR AUDIOTONE
K964669 · Miracle-Ear, Inc. · Dec 1996
DAHLBERG K-AMP BTE
K964794 · Miracle-Ear, Inc. · Dec 1996
AHS OMEGA CONCEPT
K963877 · Authorized Hearing Systems, Inc. · Dec 1996
AHS OMEGA HF
K963878 · Authorized Hearing Systems, Inc. · Dec 1996
IMPRESS, PERFECTA, ACU-FORM, AND ACUFIT
K963958 · Beltone Electronics Corp. · Dec 1996