Self-Fitting Air-Conduction Hearing Aid
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K221052 FDA 510(k)
- FDA Product Code
- QUH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.3325 FDA 510(k)
- Regulation Number
- 874.3325 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Self-Fitting Air-Conduction Hearing Aid, classified as an over-the-counter medical product designed to amplify sound for individuals with mild to moderate hearing loss. It operates by converting acoustic signals into electrical impulses, which are then processed and delivered to the ear via a receiver, improving auditory perception without requiring professional fitting adjustments.
The Self-Fitting Air-Conduction Hearing Aid is intended for home use and does not require clinical prescription or professional programming. Supplied in non-sterile packaging, these devices are reusable and must be cleaned and maintained according to manufacturer guidelines. They are classified under FDA regulation 874.3325 and have received FDA 510K clearance as Substantially Equivalent, with multiple registration numbers (e.g., 3018940143, 3023339161) under the MDR framework. No MRI safety information is specified, and devices vary by model, indicated by unique registration numbers.
Frequently asked questions
Are these hearing aids intended for individuals with severe hearing loss, or only mild to moderate cases?
These Self-Fitting Air-Conduction Hearing Aids are specifically designed for individuals with mild to moderate hearing loss. The device description explicitly states they are intended to amplify sound for this range of hearing impairment, without requiring professional fitting adjustments. They are not indicated for severe hearing loss.
Do these devices require professional fitting or programming, or can they be used right out of the box?
These hearing aids are over-the-counter and designed for self-fitting, meaning no clinical prescription or professional programming is required. They are intended for home use and can be used immediately after purchase, following the manufacturer’s instructions for setup and maintenance.
Are these hearing aids reusable, and if so, what cleaning and maintenance guidelines should be followed?
Yes, these devices are reusable and must be cleaned and maintained according to the manufacturer’s guidelines. Since they are supplied in non-sterile packaging, proper hygiene practices are essential to ensure longevity and safe use. The manufacturer’s instructions (not provided here) should outline specific cleaning protocols.
How do I determine which model of these hearing aids is right for me, given there are multiple registration numbers?
The device comes in multiple models, each identified by unique registration numbers (e.g., 3018940143, 3023339161, etc.). While the exact specifications for each model aren’t detailed here, the manufacturer likely provides compatibility guidance (e.g., ear canal size, hearing loss severity range) in their product documentation or packaging. Consulting the manufacturer’s instructions or a hearing care professional can help select the appropriate model.
Can these hearing aids be used near MRI machines, or are there any safety concerns?
The device data does not specify MRI safety information, meaning there is no confirmed guidance on whether these hearing aids are safe for use near MRI machines. If MRI exposure is a concern, it is critical to consult the manufacturer’s instructions or a healthcare provider to avoid potential risks, such as interference or damage to the device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K221052 | Class II | Active |
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Manufacturer
- Manufacturer
- Huizhou Jinghao Medical Technology Co., Ltd
- FDA Applicant
- Huizhou Jinghao Medical Technology Co., Ltd.
Sources (2)
- FDA 510(k) K221052 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026