Cleared Traditional

K231550 - Sontro® OTC Hearing Aids (AI) (FDA 510(k) Clearance)

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

K231550 · Soundwave Hearing, LLC · Ear, Nose, Throat device
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Oct 2023
Decision
149d
Days
Class 2
Risk

K231550 is an FDA 510(k) clearance for the Sontro® OTC Hearing Aids (AI). Classified as Self-fitting Air-conduction Hearing Aid, Over The Counter (product code QUH), Class II - Special Controls.

Submitted by Soundwave Hearing, LLC (Oak Brook, US). The FDA issued a Cleared decision on October 26, 2023 after a review of 149 days - within the typical 510(k) review window.

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 Soundwave Hearing, LLC devices

Submission Details

510(k) Number K231550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2023
Decision Date October 26, 2023
Days to Decision 149 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
60d slower than avg
Panel avg: 89d · This submission: 149d
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

Rook Quality Systems, Inc.
Kyle Rose

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 K231550.
Concha Sol Hearing Aids (CL-1001)
K233747 · Concha Labs · Mar 2024
WSA Self-Fitting Hearing Aid Gen 2
K233464 · Wsaud A/S · Feb 2024
Self-Fitting hearing aids
K221052 · Huizhou Jinghao Medical Technology Co., Ltd. · Sep 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