Cleared Traditional

K221064 - Nuheara IQbuds 2 PRO Hearing Aid (FDA 510(k) Clearance)

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

K221064 · Nuheara Limited · Ear, Nose, Throat device
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Oct 2022
Decision
202d
Days
Class 2
Risk

K221064 is an FDA 510(k) clearance for the Nuheara IQbuds 2 PRO Hearing Aid. Classified as Self-fitting Air-conduction Hearing Aid, Over The Counter (product code QUH), Class II - Special Controls.

Submitted by Nuheara Limited (Bellevue, US). The FDA issued a Cleared decision on October 30, 2022 after a review of 202 days - an extended review cycle.

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 Nuheara Limited devices

Submission Details

510(k) Number K221064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2022
Decision Date October 30, 2022
Days to Decision 202 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
113d slower than avg
Panel avg: 89d · This submission: 202d
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

Darthur Consulting
Deborah Arthur

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 K221064.
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K230538 · Sonova AG · Jun 2023