The following data is part of a premarket notification filed by Mdhearingaid with the FDA for Mdhearingaid App, Mdhearingaid Smart Hearing Aids.
| Device ID | K220303 |
| 510k Number | K220303 |
| Device Name: | MDHearingAid App, MDHearingAid Smart Hearing Aids |
| Classification | Self-fitting Air-conduction Hearing Aid |
| Applicant | MDHearingAid 150 N Michigan Avenue Suite 400 Chicago, IL 60601 |
| Contact | Doug Breaker |
| Correspondent | Doug Breaker MDHearingAid 150 N Michigan Avenue Suite 400 Chicago, IL 60601 |
| Product Code | QDD |
| CFR Regulation Number | 874.3325 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-02 |
| Decision Date | 2022-08-04 |