Cleared Traditional

K961059 - DIGIFOCUS COMPACT

K961059 is an FDA 510(k) clearance for DIGIFOCUS COMPACT, 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 50-day FDA review.

K961059 · Oticon, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
50d
Days
Class 1
Risk

K961059 is an FDA 510(k) clearance for the DIGIFOCUS COMPACT. 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 May 7, 1996 after a review of 50 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 - K961059

510(k) Number K961059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1996
Decision Date May 07, 1996
Days to Decision 50 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 90d · This submission: 50d
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 953
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K961059.
PHONAK PICONET2 P2 AZ
K961622 · Phonak, Inc. · May 1996
CLARITY
K961670 · Seig Technologies, Inc. · May 1996
COMFORTONE PHS
K960741 · Comfortone America'S Value Hearing Aid Line · May 1996
TECHNA TONE
K961082 · Techna Tone · May 1996
TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40
K961143 · Telex Communications, Inc. · May 1996
AUDIO 'D' INTIMA CIC
K961308 · Hearing Solutions, Inc. · May 1996