Cleared Traditional

K220303 - MDHearingAid app, MDHearingAid Smart hearing aids (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence.

K220303 · Mdhearingaid · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2022
Decision
183d
Days
Class 2
Risk

K220303 is an FDA 510(k) clearance for the MDHearingAid app, MDHearingAid Smart hearing aids. Classified as Self-fitting Air-conduction Hearing Aid, Prescription (product code QDD), Class II - Special Controls.

Submitted by Mdhearingaid (Chicago, US). The FDA issued a Cleared decision on August 4, 2022 after a review of 183 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3325 - 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 Mdhearingaid devices

Submission Details

510(k) Number K220303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2022
Decision Date August 04, 2022
Days to Decision 183 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 89d · This submission: 183d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QDD Self-fitting Air-conduction Hearing Aid, Prescription
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3325
Definition A Self-fitting Air-conduction Hearing Aid Is A Wearable Sound Amplifying Device That Is Intended To Compensate For Impaired Hearing And Incorporates Technology, Including Software, That Allows Users To Program Their Hearing Aids. This Technology Integrates User Input With A Self-fitting Strategy And Enables Users To Independently Derive And Customize Their Hearing Aid Fitting And Settings. This Is A Prescription Hearing Aid.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Ear, Nose, Throat devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT05165121 Completed Interventional Industry-sponsored

Comparison of Hearing Aid Fitting Outcomes Between Self-fit and Professional Fit for MDHearing Smart Hearing Aids

91
Patients (actual)
1
Site
Other
Purpose
Open label
Masking
Condition studied Hearing Loss
Study design Parallel
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Yunfang Zheng, Sc.D. CCC-A
Sponsor MDHearingAid (industry)
Started 2020-09-21 → Primary completion 2021-08-30 → Completed 2021-09-24
Primary outcome
Number of Participants With Improvement at 1 Month as Measured by the Abbreviated Profile of Hearing Aid Benefit (APHAB) and Speech Spatial Qualities 12 (SSQ 12) Scale.
View full study on ClinicalTrials.gov

Regulatory Peers - QDD Self-fitting Air-conduction Hearing Aid, Prescription

Devices cleared under the same product code (QDD) and FDA review panel - the closest regulatory comparables to K220303.
Lumen 155-SF
K223911 · Intricon Corporation · Oct 2023
Vibe SF Self-Fitting Hearing Aid
K220403 · Wsaud A/S · Aug 2022
Jabra Enhance Plus
K213424 · GN Hearing A/S · Jan 2022
BHA100 Series Braun Clear Hearing Aid
K212609 · Kaz USA, Inc., A Helen of Troy Company · Jan 2022
Bose SoundControl Hearing Aids
K211008 · Bose Corporation · May 2021