Cleared Traditional

K950319 - RESOUND(R) PERSONAL HEARING SYSTEM ED-3 ENCORE

K950319 is an FDA 510(k) clearance for RESOUND PERSONAL HEARING SYSTEM ED-3 ENCORE, manufactured by Resound Corp.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K950319 · Resound Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
13d
Days
Class 1
Risk

K950319 is an FDA 510(k) clearance for the RESOUND(R) PERSONAL HEARING SYSTEM ED-3 ENCORE. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Resound Corp. (Redwood City, US). The FDA issued a Cleared decision on February 8, 1995 after a review of 13 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 Resound Corp. devices

FDA 510(k) Submission Details - K950319

510(k) Number K950319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1995
Decision Date February 08, 1995
Days to Decision 13 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
77d faster than avg
Panel avg: 90d · This submission: 13d
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 K950319.
DYNA 231X
K950758 · Phonak, Inc. · Mar 1995
RESOUND(R) RESOURCE(TM)
K945750 · Resound Corp. · Mar 1995
MICRO MINI PRIMO AGC, MICRO-MINI PRIMO S-AGC
K944851 · Rexton, Inc. · Feb 1995
LX-ITC
K946071 · Widex Hearing Aid Co., Inc. · Jan 1995
MAICO IN-THE-EAR MODEL RD 201
K946253 · Maico Hearing Instruments, Inc. · Jan 1995
UNITRON MODEL VISTA 1000 SIGMA, AIR CONDUCTION HEARING AID
K946323 · Unitron Industries, Inc. · Jan 1995