Cleared Traditional

K895843 - AHAC ITE MODEL ENTENDRE

K895843 is an FDA 510(k) clearance for AHAC ITE MODEL ENTENDRE, manufactured by Aroostook Hearing Aid. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K895843 · Aroostook Hearing Aid · Ear, Nose, Throat device
Download Printable Device Report (PDF)
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Apr 1990
Decision
195d
Days
Class 1
Risk

K895843 is an FDA 510(k) clearance for the AHAC ITE MODEL ENTENDRE. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Aroostook Hearing Aid (Brewer, US). The FDA issued a Cleared decision on April 16, 1990 after a review of 195 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 Aroostook Hearing Aid devices

FDA 510(k) Submission Details - K895843

510(k) Number K895843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1989
Decision Date April 16, 1990
Days to Decision 195 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
106d slower than avg
Panel avg: 89d · This submission: 195d
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 K895843.
SEARS MODEL 9098 ITE HEARING AID
K901351 · Miracle-Ear, Inc. · Apr 1990
AUDIOTONE MODEL FFI ITE HEARING AID
K901556 · Miracle-Ear, Inc. · Apr 1990
BTE HEARING AID, UNITRON MODELS US80PP AND US80PPL
K901569 · Unitron Industries, Inc. · Apr 1990
SEARS MODEL LI9097 IN-THE-EAR HEARING INSTRUMENT
K901387 · Miracle-Ear, Inc. · Apr 1990
SEARS MODEL LM9091 IN-THE-EAR HEARING INSTRUMENT
K901388 · Miracle-Ear, Inc. · Apr 1990
SEARS MODEL LC9092 IN-THE-EAR HEARING INSTRUMENT
K901389 · Miracle-Ear, Inc. · Apr 1990