Sontro® OTC Hearing Aids (AI)— 510(k) K231550

Name: FDA 510(k) clearance K231550
Creator: U.S. Food and Drug Administration
Published: 2023-10-26

Substantially Equivalent

Soundwave Hearing, LLC

FDA 510(k) clearance K231550 for Sontro® OTC Hearing Aids (AI), Substantially Equivalent on 2023-10-26. Applicant: Soundwave Hearing, LLC. Device class: 2.

Clearance details

Applicant: Soundwave Hearing, LLC
Product code: Code QUH
Device class: Class 2
Regulation: 21 CFR 874.3325
Advisory panel: Ear, Nose, Throat
Date received: 2023-05-30
Decision date: 2023-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oak Brook, IL, US

Download summary PDF View on FDA.gov ↗

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K254108 — Jabra Enhance Select Self-fit (Jabra Enhance Select 550)2026-06-25
K233747 — Concha Sol Hearing Aids (CL-1001)2024-03-15
K233464 — WSA Self-Fitting Hearing Aid Gen 22024-02-09
K221052 — Self-Fitting hearing aids2023-09-25
K223848 — Intrisound Tuned Lumen® 155 Hearing Aids2023-09-08

Adverse events under product code QUH

product code QUH

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.