Cleared Traditional

K971605 - RESOUND ED4 PERSONAL HEARING SYSTEM W/R...

K971605 is the FDA 510(k) clearance for RESOUND ED4 PERSONAL HEARING SYSTEM W/R... by Resound Corp.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K971605 · Resound Corp. · Ear, Nose, Throat device
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Jul 1997
Decision
63d
Days
Class 1
Risk

K971605 is an FDA 510(k) clearance for the RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION. 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 July 3, 1997 after a review of 63 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

Submission Details

510(k) Number K971605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1997
Decision Date July 03, 1997
Days to Decision 63 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
26d faster than avg
Panel avg: 89d · This submission: 63d
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 K971605.
MIRACLE-EAR DIGITAL BTE
K972344 · Miracle-Ear, Inc. · Jul 1997
DAHLBERG/MIRACLE-EAR
K972345 · Miracle-Ear, Inc. · Jul 1997
MIRACLE-EAR ITE DIGITAL
K972346 · Miracle-Ear, Inc. · Jul 1997
WIDEX SENSO DIGITAL (MINI CANAL)
K971535 · Widex Hearing Aid Co., Inc. · Jun 1997
RIONET HB-79P
K971693 · Authorized Hearing Systems, Inc. · Jun 1997
UNITRON MODEL SOUND F/X CIC
K970692 · Unitron Industries, Inc. · May 1997