Cleared Traditional

K951712 - HEARING AID (ALL-IN-THE-EAR)

K951712 is an FDA 510(k) clearance for HEARING AID (ALL-IN-THE-EAR), manufactured by Omega Hearing Aid Center. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K951712 · Omega Hearing Aid Center · Ear, Nose, Throat device
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Sep 1995
Decision
152d
Days
Class 1
Risk

K951712 is an FDA 510(k) clearance for the HEARING AID (ALL-IN-THE-EAR). Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Omega Hearing Aid Center (Bakersfield, US). The FDA issued a Cleared decision on September 12, 1995 after a review of 152 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 Omega Hearing Aid Center devices

FDA 510(k) Submission Details - K951712

510(k) Number K951712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1995
Decision Date September 12, 1995
Days to Decision 152 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
63d slower than avg
Panel avg: 89d · This submission: 152d
Pathway characteristics
Predicate-based equivalence.

ESD Device Classification - Class 1, General Controls

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 740
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K951712.
MAICO PRODIGY CIC SERIES
K954054 · Maico Hearing Instruments, Inc. · Sep 1995
3M MODEL 8295
K954067 · 3M Company · Sep 1995
PHONAK 9900 CIC
K953921 · Phonak, Inc. · Sep 1995
UNITRON MODEL IKON AOHPL
K953646 · Unitron Industries, Inc. · Aug 1995
PHONAK PICONET 232X-AZ HEARING INSTRUMENT
K945439 · Phonak, Inc. · Aug 1995
3M MODEL 8200P MULTIPRO BTE
K953543 · 3M Company · Aug 1995