Cleared Traditional

K884871 - RESOUND HES

K884871 is the FDA 510(k) clearance for RESOUND HES by Resound Corp.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K884871 · Resound Corp. · Ear, Nose, Throat device
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Feb 1989
Decision
93d
Days
Class 1
Risk

K884871 is an FDA 510(k) clearance for the RESOUND HES, DIGITALLY PROGR., ITE HEARING AID. 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 22, 1989 after a review of 93 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Resound Corp. devices

Submission Details

510(k) Number K884871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1988
Decision Date February 22, 1989
Days to Decision 93 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 89d · This submission: 93d
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 K884871.
CUSTOM IN-THE-CANAL HEARING AID MODEL: I52A
K890703 · Oticon Corp. · Mar 1989
BTE HEARING AID OTICON MODEL: E42P
K890704 · Oticon Corp. · Mar 1989
WIDEX BTE HEARING AID MODEL Q8
K885128 · Widex Hearing Aid Co., Inc. · Mar 1989
BTE HEARING AID SIEMENS MODEL 284PP-ASP
K884583 · Siemens Hearing Instruments, Inc. · Jan 1989
HEARING AID, UNITRON BTE MODEL UM60-AGC0
K884288 · Unitron Industries, Inc. · Jan 1989
HEARING AID WIDEX BTE
K884113 · Widex Hearing Aid Co., Inc. · Dec 1988