Intrisound Tuned Lumen® 155 Hearing Aids— 510(k) K223848

Name: FDA 510(k) clearance K223848
Creator: U.S. Food and Drug Administration
Published: 2023-09-08

Substantially Equivalent

Tuned , Ltd.

FDA 510(k) clearance K223848 for Intrisound Tuned Lumen® 155 Hearing Aids, Substantially Equivalent on 2023-09-08. Applicant: Tuned , Ltd.. Device class: 2.

Clearance details

Applicant: Tuned , Ltd.
Product code: Code QUH
Device class: Class 2
Regulation: 21 CFR 874.3325
Advisory panel: Ear, Nose, Throat
Date received: 2022-12-22
Decision date: 2023-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gan Yoshiya, IL

Download summary PDF View on FDA.gov ↗

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K233464 — WSA Self-Fitting Hearing Aid Gen 22024-02-09
K231550 — Sontro® OTC Hearing Aids (AI)2023-10-26
K221052 — Self-Fitting hearing aids2023-09-25

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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.