Cleared Traditional

K963788 - PRIMOFOCUS COMPACT

K963788 is the FDA 510(k) clearance for PRIMOFOCUS COMPACT by Oticon Corp.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K963788 · Oticon Corp. · Ear, Nose, Throat device
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Nov 1996
Decision
68d
Days
Class 1
Risk

K963788 is an FDA 510(k) clearance for the PRIMOFOCUS COMPACT. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Oticon Corp. (Somerset, US). The FDA issued a Cleared decision on November 27, 1996 after a review of 68 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 Corp. devices

Submission Details

510(k) Number K963788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1996
Decision Date November 27, 1996
Days to Decision 68 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
21d faster than avg
Panel avg: 89d · This submission: 68d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 739
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K963788.
AHS OMEGA HF
K963878 · Authorized Hearing Systems, Inc. · Dec 1996
IMPRESS, PERFECTA, ACU-FORM, AND ACUFIT
K963958 · Beltone Electronics Corp. · Dec 1996
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K964035 · Phonak, Inc. · Dec 1996
AHS OMEGA K-AMP
K963875 · Authorized Hearing Systems, Inc. · Nov 1996
STARKEY A-13 SEQUEL PROGRAMMABLE, A-13 K-AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS
K964214 · Starkey Laboratories, Inc. · Nov 1996
STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS
K964244 · Starkey Laboratories, Inc. · Nov 1996