FDA Clears Neurostimulation Device for Opioid Withdrawal Relief

Spark Biomedical made changes to the next-gen device including a longer battery life.

Spark Biomedical

Spark Biomedical, Inc., an 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.

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.

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.

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