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.

View all Sonovation, Inc. Dba Avr Sonovation devices

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
34d slower than avg
Panel avg: 89d · 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 740
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