Cleared Traditional

K933963 - PAL (PERSONAL AMPLIFIER FOR LISTENING)

K933963 is an FDA 510(k) clearance for PAL (PERSONAL AMPLIFIER FOR LISTENING), manufactured by Hearing Care Products, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K933963 · Hearing Care Products, Inc. · Ear, Nose, Throat device
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Dec 1993
Decision
121d
Days
Class 1
Risk

K933963 is an FDA 510(k) clearance for the PAL (PERSONAL AMPLIFIER FOR LISTENING). Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Hearing Care Products, Inc. (Mill Valley, US). The FDA issued a Cleared decision on December 15, 1993 after a review of 121 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.

View all Hearing Care Products, Inc. devices

FDA 510(k) Submission Details - K933963

510(k) Number K933963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1993
Decision Date December 15, 1993
Days to Decision 121 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
32d slower than avg
Panel avg: 89d · This submission: 121d
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

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