Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.) Seocho-Daero, Seocho # 413 398 Platinum Tower Seoul Korea (the Republic of) ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Due to interference with the Live Listen feature of hearing aid or AirPods, the user's iPhone may perform automatic processing of the urination sound signal, resulting in lower urination volume and velocity values than expected.

Recommended Action

Per FDA guidance

On 04/21/2022, Soundable Health/ReedSmith LLP (Dain Technology, Inc.) emailed a Customer Notification informing customers that the firm has implemented a mobile application correction to the proudP application due to an issue regarding use of proudP mobile application with the iPhone Listen Live feature or hearing aids which could result in interference with the data collected by the proudP application and provide inaccurate readings. Customer are being informed that an update /correction to the application through the Apple App Store was released on April 21, 2022. If you downloaded your proudP before April 21, 2022, and have not updated the application since then, you will not be able to use proudP after April 21, 2022. Do not use any external devices or features (e.g., hearing aids, Listen Live feature) that activates your iPhone s audioprocessing function when collecting data with proudP. If for any reason you are not able to update the product, please email us at gayeong.kim@soundable.health. Do not use the product if you cannot update the product. For any questions - contact the Regulatory and Quality Assurance Manager at gayeong.kim@soundable.health