Cleared Traditional

K960494 - EUROLINE A312 SERIES OF BEHIND THE EAR ...

K960494 is the FDA 510(k) clearance for EUROLINE A312 SERIES OF BEHIND THE EAR ... by Starkey Laboratories, Inc.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K960494 · Starkey Laboratories, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
31d
Days
Class 1
Risk

K960494 is an FDA 510(k) clearance for the EUROLINE A312 SERIES OF BEHIND THE EAR AIR CONDUCTION HEARING AIDS. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Starkey Laboratories, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on March 1, 1996 after a review of 31 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 Starkey Laboratories, Inc. devices

Submission Details

510(k) Number K960494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1996
Decision Date March 01, 1996
Days to Decision 31 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
58d faster than avg
Panel avg: 89d · This submission: 31d
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 400
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K960494.
MIRACLE EAR & AUDIOTONE MODEL ITE/ITC/CIC
K960804 · Miracle-Ear, Inc. · Apr 1996
AUDIOFLEX 120
K960031 · Maico Hearing Instruments, Inc. · Mar 1996
UNITRON MODEL SOUND F/XP
K960155 · Unitron Industries, Inc. · Mar 1996
WIDEX MODEL SENSO DIGITAL (C16)
K955879 · Widex Hearing Aid Co., Inc. · Feb 1996
SONATA U-01
K955702 · Electone, Inc. · Feb 1996
WIDEX MODEL SENSO DIGITAL (C8)
K955878 · Widex Hearing Aid Co., Inc. · Feb 1996