Sibel Health, a pioneer in medical-grade wearable sensor technology, declared that its recent Letter of Intent (LOI) into the Clinical Outcome Assessment (COA) Qualification Program within the Drug Development Tool (DDT) framework has been approved by the U.S. Food and Drug Administration (FDA). With the use of a new Cough Monitoring sensor, the Aria sensor, objective cough frequency monitoring for adult patients with chronic refractory cough (CRC) has advanced to a major milestone.
Following approvals for a scratch sensor for atopic dermatitis (DDT COA #000120) and a swallow sensor for Parkinson’s illness (DDT COA #000165), this is Sibel Health’s third FDA DDT COA acceptance. As of February 12th, 2026, Sibel is jointly responsible for three of the eight digital health innovations that have ever been approved by the FDA’s stringent DDT COA program. Sibel just revealed that it has received a new $500,000 grant from the FDA to completely qualify its scratch sensor as an endpoint for atopic dermatitis, increasing its total FDA direct funding for the development of digital endpoints to over $1 million.
The newest wearable from Sibel Health, the Aria sensor, combines sophisticated acousto-mechanic sensing to identify and measure cough episodes in real time. It discreetly attaches to the suprasternal notch at the base of the neck. The gadget solves privacy issues with conventional audio recording devices by directly capturing mechanical vibrations and acoustic characteristics from the body while avoiding frequencies where voice is heard. Without recording recognizable speech, this method allows for ongoing, objective monitoring in both clinical and residential settings. Identifying cough occurrences no longer requires manual labeling thanks to an associated AI program for Aria.
“Receiving FDA acceptance into the DDT Qualification Program represents a major step forward in our mission to provide clinicians and researchers with reliable, patient-friendly tools for measuring chronic cough,” stated Steve Xu, MD, FAAD, CEO and Co-Founder of Sibel Health. “Chronic refractory cough affects up to 7 million adults annually in the U.S., significantly impacting quality of life through sleep disruption, social isolation, and emotional distress. Our sensor technology offers an objective, privacy-conscious alternative to subjective patient diaries and labor-intensive manual counting methods,” adds Benjamin Monteagudo, Senior Product Manager at Sibel Health.
Resolving an Important Unmet Need
A persistent cough that lasts longer than eight weeks and is unresponsive to standard treatment is known as chronic refractory cough. CRC, which primarily affects adults over 50, can result from a variety of factors, such as postnasal drip, asthma, and gastroesophageal reflux disease (GERD). According to studies, coughing frequently disrupts the quality of sleep and wakefulness after sleep begins, and nocturnal coughing is now one of the most common complaints from patients. In addition to medical symptoms, CRC patients describe major emotional and social effects, such as social isolation, stigma, and avoiding public places—issues that were exacerbated during the COVID-19 pandemic.
Subjective patient-reported outcomes (PROs), such as patient diaries and recollection-based questionnaires, are a major component of current clinical trial endpoints; however, they are subject to unpredictability, recall bias, and errors. In older individuals, whose cognitive impairment may further impair the accuracy of self-reported cough frequency and severity, these subjective assessments can be especially misleading. Alternative techniques that involve the laborious manual examination of audio recordings demand a large investment of time and skilled staff. Objective cough frequency is a crucial outcome indicator for therapeutic research programs aimed at adult refractory chronic cough, according to the FDA’s acceptance response to Sibel. The agency also notes that automated technologies that do not require longitudinal review by qualified persons would be extremely helpful.
The Aria sensor addresses this gap by:
- Providing continuous, objective monitoring while protecting patient privacy
- Enabling 24-hour data collection with wireless charging and mobile device connectivity
- Reducing patient and researcher burden through automated cough detection algorithms leveraging AI
Following this acceptance, Sibel Health will advance to the next phase of the FDA qualification process by submitting a comprehensive Qualification Plan (QP). “This FDA acceptance validates the clinical need for our technology and provides a clear regulatory pathway forward,” states Kevin Dwyer, Director of Regulatory Affairs and Quality Assurance at Sibel Health. “We’re committed to conducting rigorous validation studies that will support the qualification of the Aria sensor as a reliable tool for drug development and, ultimately, clinical care.”
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The information contained in this article is for educational and informational purposes only and is not intended as a health advice. We would ask you to consult a qualified professional or medical expert to gain additional knowledge before you choose to consume any product or perform any exercise.
