# K221064: Nuheara IQbuds 2 PRO Hearing Aid

- Pathway: 510(k) (Traditional)
- Applicant: Nuheara Limited
- Decided: Oct 30, 2022 after 202 days
- Product code: QUH (Self-Fitting Air-Conduction Hearing Aid, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 874.3325
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN180026 (2018). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN180026: Bose Hearing Aid, Bose Corporation (2018) Summary page 5.

## Most influential descendants
- K223911: Lumen 155-SF (2023), 0 descendants of its own

## Indications for use
The IQbuds 2 PRO Hearing Aids are intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. They are adjusted by the user to meet the user’s hearing needs. No pre-programming or hearing test is necessary. The device is intended for over the counter sale and use without the assistance of a hearing care professional.

Source page: https://510kreport.com/device/K221064
Methodology: https://510kreport.com/methodology