Cleared Traditional

K905516 - MODEL FT40 TRANSONIC(TM) HEARING AID

K905516 is an FDA 510(k) clearance for MODEL FT40 TRANSONIC(TM) HEARING AID, manufactured by Sonovation, Inc. Dba Avr Sonovation. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K905516 · Sonovation, Inc. Dba Avr Sonovation · Ear, Nose, Throat device
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Apr 1991
Decision
123d
Days
Class 1
Risk

K905516 is an FDA 510(k) clearance for the MODEL FT40 TRANSONIC(TM) HEARING AID. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Sonovation, Inc. Dba Avr Sonovation (Minneapolis, US). The FDA issued a Cleared decision on April 9, 1991 after a review of 123 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.

FDA 510(k) Submission Details - K905516

510(k) Number K905516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1990
Decision Date April 09, 1991
Days to Decision 123 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
33d slower than avg
Panel avg: 90d · This submission: 123d
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 1027
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K905516.
PHONAK 9800 SC-AF ITE HEARING INSTRUMENT
K911210 · Phonak, Inc. · Apr 1991
PHONAK 9100 SC-AF ITE HEARING INSTRUMENT
K911211 · Phonak, Inc. · Apr 1991
PHONAK 9300 SC-AF ITE HEARING INSTRUMENT
K911209 · Phonak, Inc. · Apr 1991
RESORBABLE BONE PLUG
K905740 · Zimmer, Inc. · Apr 1991
ELECTONE ITE MODEL PREMIER
K910097 · Electone, Inc. · Apr 1991
DAHLBERG MODEL LB BEHIND-THE-EAR HEARING AID
K910809 · Miracle-Ear, Inc. · Mar 1991