Cleared Traditional

PRIZM HEARING SYSTEM (K930909) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K930909 · Audioscience, Inc. · Ear, Nose, Throat device
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Aug 1993
Decision
180d
Days
Class 1
Risk

K930909 is an FDA 510(k) clearance for the PRIZM HEARING SYSTEM. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Audioscience, Inc. (Minnetonka, US). The FDA issued a Cleared decision on August 9, 1993 after a review of 180 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3300 - 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 Audioscience, Inc. devices

Submission Details

510(k) Number K930909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1993
Decision Date August 09, 1993
Days to Decision 180 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
91d slower than avg
Panel avg: 89d · This submission: 180d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ESD Hearing Aid, Air-conduction, Prescription
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.3300
Definition An Air-conduction Hearing Aid Is A Wearable Sound Amplifying Device Intended To Compensate For Impaired Hearing That Conducts Sound To The Ear Through The Air. This Is A Prescription Hearing Aid.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ESD Hearing Aid, Air-conduction, Prescription

All 18
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K930909.
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RESORBABLE BONE PLUG
K905740 · Zimmer, Inc. · Apr 1991
3M MODEL 8240 ITE HEARING AID
K910690 · 3M Company · Mar 1991