Cleared Traditional

RESOUND PERSONAL HEARING SYSTEMS MODIFICATION (K934917) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K934917 · Resound Corp. · Ear, Nose, Throat device
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Jan 1995
Decision
463d
Days
Class 1
Risk

K934917 is an FDA 510(k) clearance for the RESOUND PERSONAL HEARING SYSTEMS MODIFICATION. 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 January 19, 1995 after a review of 463 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ear, Nose, Throat submissions.

View all Resound Corp. devices

Submission Details

510(k) Number K934917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1993
Decision Date January 19, 1995
Days to Decision 463 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
374d slower than avg
Panel avg: 89d · This submission: 463d
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 18
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K934917.
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8260 SERIES 3M PROGRAMMABLE HEARING INSTRUMENTS
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MODEL 80 HEARING AID DISPENSING SYSTEM
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K905740 · Zimmer, Inc. · Apr 1991