Cleared Traditional

K221052 - Self-Fitting hearing aids (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K221052 · Huizhou Jinghao Medical Technology Co., Ltd. · Ear, Nose, Throat device
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Sep 2023
Decision
532d
Days
Class 2
Risk

K221052 is an FDA 510(k) clearance for the Self-Fitting hearing aids. Classified as Self-fitting Air-conduction Hearing Aid, Over The Counter (product code QUH), Class II - Special Controls.

Submitted by Huizhou Jinghao Medical Technology Co., Ltd. (Huizhou, CN). The FDA issued a Cleared decision on September 25, 2023 after a review of 532 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ear, Nose, Throat submissions.

View all Huizhou Jinghao Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K221052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2022
Decision Date September 25, 2023
Days to Decision 532 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
443d slower than avg
Panel avg: 89d · This submission: 532d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QUH Self-fitting Air-conduction Hearing Aid, Over The Counter
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 An Over The Counter Hearing Aid. For Information On The Final Rule “establishing Over-the-counter Hearing Aids,” Please See 87 Fr 50698, Available At Https://www.govinfo.gov/content/pkg/fr-2022-08-17/pdf/2022-17230.pdf.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Consultant

Shenzhen Reanny Medical Devices Management Consulting Co., Ltd.
Reanny Wang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - QUH Self-fitting Air-conduction Hearing Aid, Over The Counter

All 8
Devices cleared under the same product code (QUH) and FDA review panel - the closest regulatory comparables to K221052.
Concha Sol Hearing Aids (CL-1001)
K233747 · Concha Labs · Mar 2024
WSA Self-Fitting Hearing Aid Gen 2
K233464 · Wsaud A/S · Feb 2024
Sontro® OTC Hearing Aids (AI)
K231550 · Soundwave Hearing, LLC · Oct 2023
Intrisound™ Tuned Lumen® 155 Hearing Aids
K223848 · Tuned , Ltd. · Sep 2023
All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid
K230538 · Sonova AG · Jun 2023
Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application
K223137 · Hearx SA (Pty) , Ltd. · Mar 2023