Self-Fitting hearing aids
FDA 510(k) K221052 · Huizhou Jinghao Medical Technology Co., Ltd.
Submission
- Device name
- Self-Fitting hearing aids
- Applicant
- Huizhou Jinghao Medical Technology Co., Ltd.
Huizhou, CN - Received
- April 11, 2022
- Decision date
- September 25, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QUH – Self-Fitting Air-Conduction Hearing Aid, Over The Counter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3325
- Specialty
- Ear, Nose, Throat
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…
Other 510(k)s with product code QUH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254108 | Jabra Enhance Select Self-fit (Jabra Enhance Select 550)QUH · Traditional | GN Hearing A/S | 06/25/2026SE |
| K233747 | Concha Sol Hearing Aids (CL-1001)QUH · Traditional | Concha Labs | 03/15/2024SE |
| K233464 | WSA Self-Fitting Hearing Aid Gen 2QUH · Special | Wsaud A/S | 02/09/2024SE |
| K231550 | Sontro® OTC Hearing Aids (AI)QUH · Traditional | Soundwave Hearing, LLC | 10/26/2023SE |
| K223848 | Intrisound Tuned Lumen® 155 Hearing AidsQUH · Traditional | Tuned , Ltd. | 09/08/2023SE |
| K230538 | All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing AidQUH · Traditional | Sonova AG | 06/16/2023SE |
| K223137 | Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie ApplicationQUH · Traditional | Hearx SA (Pty) , Ltd. | 03/14/2023SE |
| K221698 | Eargo 5 , Eargo 6QUH · Traditional | Eargo, Inc. | 12/21/2022SE |
| K221064 | Nuheara IQbuds 2 PRO Hearing AidQUH · Traditional | Nuheara Limited | 10/30/2022SE |
Questions and answers
When was Self-Fitting hearing aids cleared by the FDA?
Self-Fitting hearing aids (K221052) received a 510(k) decision of Substantially Equivalent on September 25, 2023, 532 days after the submission was received.
What is the product code of K221052?
The FDA product code is QUH – Self-Fitting Air-Conduction Hearing Aid, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 874.3325.