Medical Device App Records Inaccurate Urinary Flow When Hearing Aids Active
The ProudP Everyday Uroflow Tracker app may record lower-than-actual urination measurements when a hearing aid or AirPods Live Listen feature is active on the same iPhone, due to interference with the app's sound-based measurement system.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device providing diagnostic measurements. Documented software interference causes measurement inaccuracy that could affect medical decisions. No reported injuries or illnesses. Meets High severity criterion as risk-of-harm product without reported harm.
Plain-English summary
The FDA is recalling the ProudP Everyday Uroflow Tracker mobile app (Software Version 1.2.0 and earlier) manufactured by Dain Technology, Inc., a subsidiary of Soundable Health, Inc. The app is a medical device that measures urinary flow by analyzing sound patterns.
When a hearing aid or AirPods Live Listen feature is active on the same iPhone, the device's automatic audio processing interferes with the app's sound analysis. This causes the app to record lower urination volume and velocity values than actually measured.
Users who rely on this app for medical monitoring may receive inaccurate results when using compatible hearing aids or AirPods Live Listen. The app was distributed worldwide and in the US via the Apple App Store.
Consumers should discontinue relying on measurements recorded while hearing aids or AirPods Live Listen features are active on their device. Contact Dain Technology, Inc. for information about software updates or alternative measurement methods.
The recalled product
- Product
- ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- prouP Version - 1.2.0 UDI Code: (01)00860006184902(10)v1.x.x
Distribution
Distributed nationwide across the United States.
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