QDD — Self-Fitting Air-Conduction Hearing Aid, Prescription Class II
FDA product code QDD covers "Self-Fitting Air-Conduction Hearing Aid, Prescription", a Class II medical device regulated under 21 CFR 874.3325. Submissions are reviewed by the Ear, Nose, Throat panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QDD
- Device Class
- Class II
- Regulation Number
- 874.3325
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
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 a prescription hearing aid.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K223911 | intricon corporation | Lumen 155-SF | October 17, 2023 |
| K220403 | wsaud | Vibe SF Self-Fitting Hearing Aid | August 12, 2022 |
| K220303 | mdhearingaid | MDHearingAid app, MDHearingAid Smart hearing aids | August 4, 2022 |
| K213424 | gn hearing | Jabra Enhance Plus | January 19, 2022 |
| K212609 | kaz usa, inc., a helen of troy | BHA100 Series Braun Clear Hearing Aid | January 5, 2022 |
| K211008 | bose corporation | Bose SoundControl Hearing Aids | May 5, 2021 |
| DEN180026 | bose corporation | Bose Hearing Aid | October 5, 2018 |