Cleared Traditional

K931942 - RESOUND PERSONAL HEARING SYSTEM BT-P W/...

K931942 is the FDA 510(k) clearance for RESOUND PERSONAL HEARING SYSTEM BT-P W/... by Resound Corp.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K931942 · Resound Corp. · Ear, Nose, Throat device
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Jul 1993
Decision
92d
Days
Class 1
Risk

K931942 is an FDA 510(k) clearance for the RESOUND PERSONAL HEARING SYSTEM BT-P W/PHS BT-P. 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 20, 1993 after a review of 92 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 K931942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1993
Decision Date July 20, 1993
Days to Decision 92 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
3d slower than avg
Panel avg: 89d · This submission: 92d
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 K931942.
PHONAK PICO-FORTE SC-D-2
K932735 · Phonak, Inc. · Jul 1993
STARKEY TRILOGY II PROGRAMMABLE HEARING AID
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351-AGCO BEHIND-THE-EAR HEARING AID
K933095 · Telex Communications, Inc. · Jul 1993
BELTONE OPERA/OPERA MHP/OPERA MAX
K932426 · Beltone Electronics Corp. · Jul 1993
PHONAK LEXA 231X ITE SERIES HEARING SINSTRUMENT
K932175 · Phonak, Inc. · Jul 1993
IN THE CANAL AID OTOSONIC ACS II WITH SRR
K931881 · Beltone Electronics Corp. · Jul 1993