Cleared Traditional

GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM) (K950730) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K950730 · Phonic Ear, Inc. · Ear, Nose, Throat device
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Jun 1995
Decision
134d
Days
Class 2
Risk

K950730 is an FDA 510(k) clearance for the GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM). Classified as Hearing Aid, Group And Auditory Trainer (product code EPF), Class II - Special Controls.

Submitted by Phonic Ear, Inc. (Petaluma, US). The FDA issued a Cleared decision on June 30, 1995 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3320 - 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 Phonic Ear, Inc. devices

Submission Details

510(k) Number K950730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1995
Decision Date June 30, 1995
Days to Decision 134 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
45d slower than avg
Panel avg: 89d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EPF Hearing Aid, Group And Auditory Trainer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3320
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.