QDD
7 FDA 510(k) clearances · Product code
147 daysmedian time to decision
292 days90th percentile
7clearances measured
FDA profile
- Official device name
- Self-Fitting Air-Conduction Hearing Aid, Prescription
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3325
- Medical specialty
- Ear, Nose, Throat
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| Lumen 155-SF (K223911) | Intricon Corporation | 2023-10-17 |
| Vibe SF Self-Fitting Hearing Aid (K220403) | Wsaud A/S | 2022-08-12 |
| MDHearingAid app, MDHearingAid Smart hearing aids (K220303) | Mdhearingaid | 2022-08-04 |
| Jabra Enhance Plus (K213424) | GN Hearing A/S | 2022-01-19 |
| BHA100 Series Braun Clear Hearing Aid (K212609) | Kaz USA, Inc., A Helen of Troy Company | 2022-01-05 |
| Bose SoundControl Hearing Aids (K211008) | Bose Corporation | 2021-05-05 |
| Bose Hearing Aid (DEN180026) | Bose Corporation | 2018-10-05 |
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Every clearance here is in the API, with alerts when new ones post.