Cleared Traditional

K895590 - ITE HEARING AID MODEL PA

K895590 is an FDA 510(k) clearance for ITE HEARING AID MODEL PA, manufactured by Best Aid, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K895590 · Best Aid, Inc. · Ear, Nose, Throat device
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Jan 1990
Decision
111d
Days
Class 1
Risk

K895590 is an FDA 510(k) clearance for the ITE HEARING AID MODEL PA. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Best Aid, Inc. (Crystal Lake, US). The FDA issued a Cleared decision on January 4, 1990 after a review of 111 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.

FDA 510(k) Submission Details - K895590

510(k) Number K895590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1989
Decision Date January 04, 1990
Days to Decision 111 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 90d · This submission: 111d
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 1059
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K895590.
MINI PRIMO PLUS ASP BEHIND-THE-EAR HEARING AID
K896057 · Rexton, Inc. · Jan 1990
REXTON RX12D CUSTOM IN-THE-EAR HEARING AID
K896056 · Rexton, Inc. · Jan 1990
AURAL-TECH ITE HEARING AID MODEL AT-1S, 1SA, 1SC
K895517 · Aural Technologies, Inc. · Jan 1990
FULL ITE, LOW PROFILE, HELIX, CANAL COMBIN/SD CANA
K894176 · Precision Hearing Instruments · Nov 1989
HEARING AID (IN-THE-EAR)
K894428 · Hearing Aid Express · Oct 1989
3M INSTANT FIT CUSTOM EARMOLD
K895134 · 3M Company · Oct 1989
K895590 · ITE HEARING AID MODEL PA
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