Cleared Traditional

K910702 - ACTIVE MODEL AHS HALF SHELL ITE HEARING AID

K910702 is an FDA 510(k) clearance for ACTIVE MODEL AHS HALF SHELL ITE HEARING AID, manufactured by Active Electronics, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K910702 · Active Electronics, Inc. · Ear, Nose, Throat device
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Feb 1991
Decision
8d
Days
Class 1
Risk

K910702 is an FDA 510(k) clearance for the ACTIVE MODEL AHS HALF SHELL ITE HEARING AID. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Active Electronics, Inc. (Blaine, US). The FDA issued a Cleared decision on February 28, 1991 after a review of 8 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 Active Electronics, Inc. devices

FDA 510(k) Submission Details - K910702

510(k) Number K910702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1991
Decision Date February 28, 1991
Days to Decision 8 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
81d faster than avg
Panel avg: 89d · This submission: 8d
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 K910702.
POST AURICULAR HEARING AID MODEL PICO SC-H
K910028 · Phonak, Inc. · Mar 1991
PHONAK MODEL PICO C-S-H-T, BTE HEARING AID
K910012 · Phonak, Inc. · Feb 1991
POST AURICULAR HEARING AID MODEL PICO-FORTE PP-SC
K910018 · Phonak, Inc. · Feb 1991
3M MODEL 8241 ITE HEARING AID
K910759 · 3M Company · Feb 1991
3M MODEL 8242 ITE HEARING AID
K910760 · 3M Company · Feb 1991
3M MODEL 8243 ITE HEARING AID
K910761 · 3M Company · Feb 1991