Cleared Traditional

HF MEGA EAR (K960567) - FDA 510(k) Clearance

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

K960567 · Maxi-Aids, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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.