Cleared Traditional

IN THE EAR HEARING AID (K915711) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K915711 · Zenith-Omni H.C., Inc. · Ear, Nose, Throat device
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Jun 1992
Decision
188d
Days
Class 1
Risk

K915711 is an FDA 510(k) clearance for the IN THE EAR HEARING AID. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Zenith-Omni H.C., Inc. (New Haven, US). The FDA issued a Cleared decision on June 10, 1992 after a review of 188 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 Zenith-Omni H.C., Inc. devices

Submission Details

510(k) Number K915711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1991
Decision Date June 10, 1992
Days to Decision 188 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
99d slower than avg
Panel avg: 89d · This submission: 188d
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 K915711.
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K935095 · 3M Company · Dec 1993
MODEL 80 HEARING AID DISPENSING SYSTEM
K913245 · 3M Company · Oct 1991
RESORBABLE BONE PLUG
K905740 · Zimmer, Inc. · Apr 1991
3M MODEL 8240 ITE HEARING AID
K910690 · 3M Company · Mar 1991