# K220303: MDHearingAid app, MDHearingAid Smart hearing aids

- Pathway: 510(k) (Traditional)
- Applicant: Mdhearingaid
- Decided: Aug 4, 2022 after 183 days
- Product code: QDD (Self-Fitting Air-Conduction Hearing Aid, Prescription)
- 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.
No later device cites it as a predicate yet.
0 of 2 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 4.

## Indications for use
The MDHearing Smart Hearing Aids are self-fitting air-conduction hearing aids, 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 direct-to-consumer sale and use without the assistance of a hearing care professional.

Source page: https://510kreport.com/device/K220303
Methodology: https://510kreport.com/methodology