Cleared Traditional

K903145 - HEARSET TELEPHONE HEARING SYSTEM

K903145 is an FDA 510(k) clearance for HEARSET TELEPHONE HEARING SYSTEM, manufactured by Starkey Laboratories, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K903145 · Starkey Laboratories, Inc. · Ear, Nose, Throat device
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Dec 1990
Decision
156d
Days
Class 1
Risk

K903145 is an FDA 510(k) clearance for the HEARSET TELEPHONE HEARING SYSTEM. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Starkey Laboratories, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on December 21, 1990 after a review of 156 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 Starkey Laboratories, Inc. devices

FDA 510(k) Submission Details - K903145

510(k) Number K903145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1990
Decision Date December 21, 1990
Days to Decision 156 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
66d slower than avg
Panel avg: 90d · This submission: 156d
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 951
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K903145.
AM130 AGC-O (BEHIND THE EAR) HEARING AID
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MEMORYMATE MODEL 8270 ITE HEARING AID
K905483 · 3M Company · Dec 1990
MEMORYMATE HEARING AID WITH PMC PROGRAMMER
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QUALITONE ITE GENESIS
K904731 · Qualitone · Dec 1990
HEARING AID, UNITRON MODEL UM60-UH
K904576 · Unitron Industries, Inc. · Dec 1990