Cleared Traditional

WIDEX HEARING AID MODELS ES9T AND ES9H (K895981) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K895981 · Widex Hearing Aid Co., Inc. · Ear, Nose, Throat device
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Mar 1990
Decision
154d
Days
Class 1
Risk

K895981 is an FDA 510(k) clearance for the WIDEX HEARING AID MODELS ES9T AND ES9H. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Widex Hearing Aid Co., Inc. (Long Island City, US). The FDA issued a Cleared decision on March 15, 1990 after a review of 154 days - an extended review 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: 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 Widex Hearing Aid Co., Inc. devices

Submission Details

510(k) Number K895981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1989
Decision Date March 15, 1990
Days to Decision 154 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 89d · This submission: 154d
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

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