Cleared Traditional

K951376 - RESOUND PERSONAL HEARING SYSTEM BT2/S S...

K951376 is the FDA 510(k) clearance for RESOUND PERSONAL HEARING SYSTEM BT2/S S... by Resound Corp.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K951376 · Resound Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
18d
Days
Class 1
Risk

K951376 is an FDA 510(k) clearance for the RESOUND PERSONAL HEARING SYSTEM BT2/S SERIES 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 April 14, 1995 after a review of 18 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 K951376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1995
Decision Date April 14, 1995
Days to Decision 18 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
71d faster than avg
Panel avg: 89d · This submission: 18d
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 K951376.
RESOUND PERSONAL HEARING SYSTEM MODELS ED3A & ED3A/S W/REMONTE CONTROL OPTION
K951379 · Resound Corp. · Apr 1995
RESOUND PERSONAL HEARING SYSTEM BT2/S-E
K951374 · Resound Corp. · Apr 1995
RESOUND PERSONAL HEARING SYSTEM ED3/S-E
K951375 · Resound Corp. · Apr 1995
RESOUND PERSONAL HEARING SYSTEM BTP/S-A W/REMOTE CONTROL OPTION
K951377 · Resound Corp. · Apr 1995
BELTONE COMPARAFIT
K946340 · Beltone Electronics Corp. · Apr 1995
SILVER ULTRA MINI CANAL
K950458 · Electone, Inc. · Mar 1995