Spark Biomedical’s second-generation device, Sparrow® Ascent, Receives FDA Clearance for Opioid Withdrawal Relief in Adults

Spark Biomedical’s second-generation device, Sparrow® Ascent, Receives FDA Clearance for Opioid Withdrawal Relief in Adults

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This FDA-cleared wearable neuromodulation system offers game-changing access for patients to start the road to recovery without interruptions to daily living

DALLAS, TX, July 11, 2023 (GLOBE NEWSWIRE) — Spark Biomedical, Inc., a leading innovator in wearable neurostimulation development, is proud to announce that its next-generation, groundbreaking product, Sparrow Ascent, has received clearance from the U.S. Food and Drug Administration (FDA).  Sparrow Ascent is a wearable neurostimulation device designed to provide safe, comfortable, drug-free relief for individuals experiencing opioid withdrawal symptoms.

Spark’s original product, The Sparrow Therapy System, received FDA clearance in January of 2021 and was designed primarily for use within in-patient clinical settings. The next-generation product, Sparrow Ascent, has been reimagined for more versatile patient use including — in-patient, out-patient, or in the comfort of their homes via telehealth. Ascent also incorporates valuable insights and user feedback, including:

  • Ergonomically designed patient controller with LCD screen
  • Longer battery life
  • 28 lightweight, flexible, earpieces to address the prolonged withdrawal experience now seen with the prevalence of fentanyl

These changes, among others, were developed to give patients more control over their opioid withdrawal therapy and empower them to receive treatment on their own terms.

Daniel Powell, CEO of Spark Biomedical, stated, "This is a significant milestone for Spark Biomedical and a tremendous step forward in our mission to combat the opioid crisis. We are proud to offer a wearable solution that has the potential to revolutionize the way opioid withdrawal symptoms are managed, providing much-needed drug-free relief to individuals on their journey to recovery.

In developing this next-generation product, we’ve taken patient and physician feedback to heart, and we’re thrilled to have FDA clearance for Sparrow Ascent now in the rearview mirror. By removing as much friction as possible from the prescription process and therapy activation, we hope to offer the over two million U.S. adults affected by opioid use disorder (OUD) an easier path to regain control of their lives without the burden of systemic side effects or disruptions to their daily routines. It is only by listening to physicians, patients, and caregivers and then taking action that we can fulfill our commitment to transform the landscape of OUD treatment and empower individuals to overcome opioid dependency."

OUD continues to be a critical public health crisis in the United States, affecting millions of individuals and resulting in countless tragic deaths from opioid overdose. According to recent statistics from the National Institute on Drug Abuse (NIDA), over two million Americans suffer from OUD. In 2022 alone, more than 79,770 deaths occurred due to opioid-involved overdoses. The need for innovative solutions to address this devastating issue has never been more urgent.

Sparrow Ascent represents a breakthrough in the treatment of opioid withdrawal symptoms, offering hope to those navigating the challenging path of recovery. By utilizing neurostimulation technology, Sparrow Ascent targets specific regions of the brain associated with the withdrawal process, providing non-invasive relief from withdrawal symptoms such as nausea, vomiting, insomnia, anxiety, tremors, and muscle aches, among others.

Alejandro Covalin, Ph.D. Chief Technology Officer of Spark Biomedical, shared his excitement, saying, "The FDA clearance of Sparrow Ascent validates years of dedicated research, clinical trial work, and product development. We are confident that our wearable neurostimulation device will make a meaningful difference in the lives of those struggling with OUD, offering a new avenue for relief and helping them take control of their recovery."

Spark Biomedical is committed to partnering with healthcare providers, addiction treatment centers, and other stakeholders to ensure widespread access to Sparrow Ascent. The company is working diligently to obtain widespread reimbursement.

For further information or media inquiries, please contact:

Candace Rempe
Brand Engagement Manager
Spark Biomedical
844-655-7775 (SPRK)

Indication for Use

The Sparrow Ascent is a transcutaneous nerve field stimulator intended to be used in patients experiencing opioid withdrawal in conjunction with standard symptomatic medications and other therapies for opioid withdrawal symptoms under the supervision of trained clinical personnel.

About Spark Biomedical

Spark Biomedical, Inc. is a leading U.S.-based wearable neurostimulation solutions developer devoted to the life-saving work of helping 36.3 million people worldwide overcome withdrawal, heal from addiction, and achieve the better quality of life they deserve. With opioid-related misuse and overdose deaths on the rise, the company’s mission is to eliminate opioid use disorder by working to address the full lifecycle, including withdrawal management, opioid-sparing, relapse prevention, and PTSD/trauma abatement.

Spark Biomedical is helping patients take the first step of overcoming acute opioid withdrawal with its FDA-cleared wearable technology, the Sparrow Ascent— Transcutaneous Auricular Neurostimulation (tAN®) for Opioid Withdrawal Relief. Sparrow Ascent provides an easy, safe, and effective drug-free treatment option supported by clinical evidence. Next steps are underway with the launch of two NIDA-funded clinical trials to improve adult relapse rates and help infants suffering from Neonatal Opioid Withdrawal Syndrome (NOWS).

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