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# FDA Accepts Sibel Aria Cough Sensor in DDT
- URL: https://www.fdaweb.com/fda-accepts-sibel-aria-cough-sensor-in-ddt/
- Published: 2026-02-20T12:00:00.000Z
- Updated: 2026-09-14T13:34:08.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160699

FDA has accepted a Sibel Health Letter of Intent for its Aria cough monitor into the Clinical Outcome Assessment Qualification Program under the Drug Development Tool framework. A company [statement](https://www.prnewswire.com/news-releases/sibel-health-receives-fda-acceptance-into-drug-development-tool-qualification-program-for-innovative-cough-monitoring-sensor-302692175.html?ref=fdaweb.com) says the Aria sensor adheres directly to the suprasternal notch at the base of the neck and uses advanced acousto-mechanical sensing to detect and quantify cough events in real time.

The statement says chronic refractory coughs last more than eight weeks and remain resistant to conventional treatment. They often affect adults over age 50 and can arise from multiple causes, such as postnasal drip, asthma, and gastroesophageal reflux disease. It says that current clinical endpoints rely on subjective patient-reported outcomes that can be particularly unreliable in older adults.

Sibel says Aria:

- provides continuous objective monitoring while protecting patient privacy;
- enables 24-hour data collection with wireless charging and mobile device connectivity; and
- reduces patient and researcher burden through automated cough detection algorithms leveraging artificial intelligence.

Following this acceptance, Sibel says it will advance to the next phase of the FDA qualification process by submitting a comprehensive Qualification Plan.