Cleared Traditional

AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER (K970340) - FDA 510(k) Clearance

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

K970340 · Bellab · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Mar 1997
Decision
56d
Days
Class 2
Risk

K970340 is an FDA 510(k) clearance for the AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER. Classified as Device, Assistive Listening (product code LZI), Class II - Special Controls.

Submitted by Bellab (Gothenburg, SE). The FDA issued a Cleared decision on March 26, 1997 after a review of 56 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bellab devices

Submission Details

510(k) Number K970340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1997
Decision Date March 26, 1997
Days to Decision 56 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
33d faster than avg
Panel avg: 89d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LZI Device, Assistive Listening
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.