QUH — Self-Fitting Air-Conduction Hearing Aid, Over The Counter Class II
FDA product code QUH covers "Self-Fitting Air-Conduction Hearing Aid, Over The Counter", a Class II medical device regulated under 21 CFR 874.3325. Submissions are reviewed by the Ear, Nose, Throat panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QUH
- 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 an over the counter hearing aid. For information on the final rule Establishing Over-the-Counter Hearing Aids, please see 87 FR 50698, available at https://www.govinfo.gov/content/pkg/FR-2022-08-17/pdf/2022-17230.pdf.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K254108 | gn hearing | Jabra Enhance Select Self-fit (Jabra Enhance Select 550) | June 25, 2026 |
| K233747 | concha labs | Concha Sol Hearing Aids (CL-1001) | March 15, 2024 |
| K233464 | wsaud | WSA Self-Fitting Hearing Aid Gen 2 | February 9, 2024 |
| K231550 | soundwave hearing | Sontro® OTC Hearing Aids (AI) | October 26, 2023 |
| K221052 | huizhou jinghao medical technology co | Self-Fitting hearing aids | September 25, 2023 |
| K223848 | tuned | Intrisound Tuned Lumen® 155 Hearing Aids | September 8, 2023 |
| K230538 | sonova | All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid | June 16, 2023 |
| K223137 | hearx sa (pty) | Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application | March 14, 2023 |
| K221698 | eargo | Eargo 5 , Eargo 6 | December 21, 2022 |
| K221064 | nuheara limited | Nuheara IQbuds 2 PRO Hearing Aid | October 30, 2022 |