Cleared Traditional

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

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

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

Submitted by Nuheara Limited (Bellevue, US). The FDA issued a Cleared decision on October 30, 2022, 202 days after receiving the submission on April 11, 2022.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3325. 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..

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

Device Classification

Product Code QUH - Self-fitting Air-conduction Hearing Aid, Over The Counter
Device Class Class II - 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.