Cleared Traditional

K911498 - ADJUSTRETTE - DAO

K911498 is the FDA 510(k) clearance for ADJUSTRETTE - DAO by Qualitone. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K911498 · Qualitone · Ear, Nose, Throat device
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Apr 1991
Decision
21d
Days
Class 1
Risk

K911498 is an FDA 510(k) clearance for the ADJUSTRETTE - DAO, MODIFICATION. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Qualitone (Minneapolis, US). The FDA issued a Cleared decision on April 19, 1991 after a review of 21 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 Qualitone devices

Submission Details

510(k) Number K911498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1991
Decision Date April 19, 1991
Days to Decision 21 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
68d faster than avg
Panel avg: 89d · This submission: 21d
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 K911498.
STOCK CANAL, IN-THE-EAR HEARING AID
K911709 · Electone, Inc. · May 1991
STARKEY TRILOGY PROGRAM HEAR AID CC/CE MODELS
K911579 · Starkey Laboratories, Inc. · May 1991
CUSTOM PERSONAL EAR - CPE
K911497 · Qualitone · Apr 1991
ELEGANCE - DEO, MODIFICATION
K911499 · Qualitone · Apr 1991
ULTRA & ULTRA LITE II, MODIFICATION
K911504 · Qualitone · Apr 1991
PHONAK 9800 SC-AF ITE HEARING INSTRUMENT
K911210 · Phonak, Inc. · Apr 1991