Cleared Traditional

K964816 - AUDINA 153 BEHIND THE EAR AND AUDINA 15...

K964816 is an FDA 510(k) clearance for AUDINA 153 BEHIND THE EAR AND AUDINA 15..., manufactured by Audina Hearing Instrument. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K964816 · Audina Hearing Instrument · Ear, Nose, Throat device
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Jan 1997
Decision
49d
Days
Class 1
Risk

K964816 is an FDA 510(k) clearance for the AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Audina Hearing Instrument (Longwood, US). The FDA issued a Cleared decision on January 17, 1997 after a review of 49 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 Audina Hearing Instrument devices

FDA 510(k) Submission Details - K964816

510(k) Number K964816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1996
Decision Date January 17, 1997
Days to Decision 49 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 89d · This submission: 49d
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 K964816.
AUDIOTONE (A-552)
K965063 · Miracle-Ear, Inc. · Jan 1997
SENSO DIGITAL (C18)
K965218 · Widex Hearing Aid Co., Inc. · Jan 1997
TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II
K964639 · Telex Communications, Inc. · Jan 1997
MIRACLE-EAR OR AUDIOTONE
K964669 · Miracle-Ear, Inc. · Dec 1996
DAHLBERG K-AMP BTE
K964794 · Miracle-Ear, Inc. · Dec 1996
AHS OMEGA CONCEPT
K963877 · Authorized Hearing Systems, Inc. · Dec 1996