All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid
FDA 510(k) K230538 · Sonova AG
Submission
- Device name
- All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid
- Applicant
- Sonova AG
Zurich, CH - Received
- February 27, 2023
- Decision date
- June 16, 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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| 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 |
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| K223848 | Intrisound Tuned Lumen® 155 Hearing AidsQUH · Traditional | Tuned , Ltd. | 09/08/2023SE |
| 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 |
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| K232999 | Lyric4 Hearing AidESD · Traditional | 04/11/2024SE |
Questions and answers
When was All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid cleared by the FDA?
All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid (K230538) received a 510(k) decision of Substantially Equivalent on June 16, 2023, 109 days after the submission was received.
What is the product code of K230538?
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.