Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application
FDA 510(k) K223137 · Hearx SA (Pty) , Ltd.
Submission
- Device name
- Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application
- Applicant
- Hearx SA (Pty) , Ltd.
Pretoria, ZA - Received
- October 4, 2022
- Decision date
- March 14, 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…
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|---|---|---|---|
| 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 |
| K221052 | Self-Fitting hearing aidsQUH · Traditional | Huizhou Jinghao Medical Technology Co., Ltd. | 09/25/2023SE |
| 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 |
| K221698 | Eargo 5 , Eargo 6QUH · Traditional | Eargo, Inc. | 12/21/2022SE |
| K221064 | Nuheara IQbuds 2 PRO Hearing AidQUH · Traditional | Nuheara Limited | 10/30/2022SE |
More from Nuheara Limited
| 510(k) | Device | Decision |
|---|---|---|
| K231545 | hearOAEEWO · Traditional | 10/27/2023SE |
Questions and answers
When was Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application cleared by the FDA?
Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application (K223137) received a 510(k) decision of Substantially Equivalent on March 14, 2023, 161 days after the submission was received.
What is the product code of K223137?
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.