Cleared Traditional

K963745 - MODEL WMR BTE HEARING INSTRUMENT (MODEL...

K963745 is an FDA 510(k) clearance for MODEL WMR BTE HEARING INSTRUMENT (MODEL..., manufactured by Hearing Innovations, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K963745 · Hearing Innovations, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
70d
Days
Class 1
Risk

K963745 is an FDA 510(k) clearance for the MODEL WMR BTE HEARING INSTRUMENT (MODEL WMR). Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Hearing Innovations, Inc. (Tucson, US). The FDA issued a Cleared decision on November 26, 1996 after a review of 70 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 Hearing Innovations, Inc. devices

FDA 510(k) Submission Details - K963745

510(k) Number K963745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1996
Decision Date November 26, 1996
Days to Decision 70 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
19d faster than avg
Panel avg: 89d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

ESD Device Classification - Class 1, General Controls

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 740
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K963745.
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K963874 · Authorized Hearing Systems, Inc. · Nov 1996
AHS OMEGA PP
K963876 · Authorized Hearing Systems, Inc. · Nov 1996