Cleared Traditional

RESOUND PERSONAL HEARING SYSTEM SOUNDLINK-1 (K922570) - FDA 510(k) Clearance

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

K922570 · Resound Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
66d
Days
Class 2
Risk

K922570 is an FDA 510(k) clearance for the RESOUND PERSONAL HEARING SYSTEM SOUNDLINK-1. Classified as Hearing Aid, Group And Auditory Trainer (product code EPF), Class II - Special Controls.

Submitted by Resound Corp. (Redwood City, US). The FDA issued a Cleared decision on August 6, 1992 after a review of 66 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 Resound Corp. devices

Submission Details

510(k) Number K922570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1992
Decision Date August 06, 1992
Days to Decision 66 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
23d faster than avg
Panel avg: 89d · This submission: 66d
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.