Cleared Traditional

K910148 - AM130 AGC-O (BEHIND THE EAR) HEARING AID

K910148 is the FDA 510(k) clearance for AM130 AGC-O (BEHIND THE EAR) HEARING AID by Electone, Inc.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K910148 · Electone, Inc. · Ear, Nose, Throat device
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Jan 1991
Decision
15d
Days
Class 1
Risk

K910148 is an FDA 510(k) clearance for the AM130 AGC-O (BEHIND THE EAR) HEARING AID. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Electone, Inc. (Winter Park, US). The FDA issued a Cleared decision on January 29, 1991 after a review of 15 days - a notably fast clearance 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: 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 Electone, Inc. devices

Submission Details

510(k) Number K910148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1991
Decision Date January 29, 1991
Days to Decision 15 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 89d · This submission: 15d
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 739
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K910148.
ELECTONE BTE MODEL AM 130 PP
K910101 · Electone, Inc. · Jan 1991
ELECTONE BTE MODEL AM 240 PPL
K910102 · Electone, Inc. · Jan 1991
ELECTONE BTE MODEL AM 130 HF
K910103 · Electone, Inc. · Jan 1991
ELECTONE BTE MODEL AM 240 PPI
K910098 · Electone, Inc. · Jan 1991
MEMORYMATE MODEL 8270 ITE HEARING AID
K905483 · 3M Company · Dec 1990
HEARSET TELEPHONE HEARING SYSTEM
K903145 · Starkey Laboratories, Inc. · Dec 1990