Nuheara IQbuds 2 PRO Hearing Aid— 510(k) K221064

Name: FDA 510(k) clearance K221064
Creator: U.S. Food and Drug Administration
Published: 2022-10-30

Substantially Equivalent

Nuheara Limited

FDA 510(k) clearance K221064 for Nuheara IQbuds 2 PRO Hearing Aid, Substantially Equivalent on 2022-10-30. Applicant: Nuheara Limited. Device class: 2.

Clearance details

Applicant: Nuheara Limited
Product code: Code QUH
Device class: Class 2
Regulation: 21 CFR 874.3325
Advisory panel: Ear, Nose, Throat
Date received: 2022-04-11
Decision date: 2022-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellevue, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QUH

view all

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
K231550 — Sontro® OTC Hearing Aids (AI)2023-10-26
K221052 — Self-Fitting hearing aids2023-09-25

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.