Cleared Traditional

K960567 - HF MEGA EAR

K960567 is an FDA 510(k) clearance for HF MEGA EAR, manufactured by Maxi-Aids, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EPF cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K960567 · Maxi-Aids, Inc. · Ear, Nose, Throat device
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Oct 1996
Decision
250d
Days
Class 2
Risk

K960567 is an FDA 510(k) clearance for the HF MEGA EAR. Classified as Hearing Aid, Group And Auditory Trainer (product code EPF), Class II - Special Controls.

Submitted by Maxi-Aids, Inc. (Farmingdale, US). The FDA issued a Cleared decision on October 16, 1996 after a review of 250 days - an extended review cycle.

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 Maxi-Aids, Inc. devices

FDA 510(k) Submission Details - K960567

510(k) Number K960567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1996
Decision Date October 16, 1996
Days to Decision 250 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
161d slower than avg
Panel avg: 89d · This submission: 250d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EPF Device Classification - Class 2, Special Controls

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.

Regulatory Peers - EPF Hearing Aid, Group And Auditory Trainer

All 21
Devices cleared under the same product code (EPF) and FDA review panel - the closest regulatory comparables to K960567.
TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION
K982683 · Telex Communications, Inc. · Oct 1998
INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT
K974658 · Phonic Ear, Inc. · Feb 1998
FM RECEIVER - AUDITORY TRAINER
K974287 · Phonic Ear, Inc. · Feb 1998
GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM)
K950730 · Phonic Ear, Inc. · Jun 1995
PHONAK MICROVOX RESONAL FM SYSTEM
K941768 · Phonak, Inc. · Jun 1994
PHONIC EAR
K940313 · Phonic Ear, Inc. · Mar 1994