Cleared Traditional

K911183 - NHS 2044P BODY AID

K911183 is an FDA 510(k) clearance for NHS 2044P BODY AID, manufactured by Magnatone Hearing Aid Corp.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K911183 · Magnatone Hearing Aid Corp. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Jul 1991
Decision
113d
Days
Class 1
Risk

K911183 is an FDA 510(k) clearance for the NHS 2044P BODY AID, HEARING AID. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Magnatone Hearing Aid Corp. (Casselberry, US). The FDA issued a Cleared decision on July 9, 1991 after a review of 113 days - within the typical 510(k) review window.

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 Magnatone Hearing Aid Corp. devices

FDA 510(k) Submission Details - K911183

510(k) Number K911183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1991
Decision Date July 09, 1991
Days to Decision 113 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 89d · This submission: 113d
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 K911183.
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K911810 · Siemens Hearing Instruments, Inc. · Jun 1991
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K911811 · Siemens Hearing Instruments, Inc. · Jun 1991
PHONAK PHONICA MODEL 312-C ITE HEARING INSTRUMENT
K912570 · Phonak, Inc. · Jun 1991