Closed-loop stimulation to restore voice and swallowing by reanimating paralyzed vocal folds - this direct to phase 2 sbir proposal will advance the development of a closed-loop electrical stimulation…

The National Institute on Deafness and Other Communication Disorders awarded Micro-Leads Inc. $1.486 million on August 1, 2026, under the Research Related to Deafness and Communication Disorders program (CFDA 93.173) to develop a closed-loop electrical stimulation therapy for unilateral vocal fold paralysis that restores natural voice and swallowing function.

Micro-Leads will design and develop a closed-loop laryngeal electrical stimulation system that detects and responds to physiological needs to reanimate paralyzed vocal folds, addressing the approximately 100,000 individuals annually who lack adequate treatment options. The proposed system builds on FDA-approved predecessor devices and incorporates novel elements including directional field delivery, closed-loop detect-and-treat capabilities, and ultra-miniaturized size. Phase 1 work will custom-design a two-sided injectable micro-paddle based on separately funded nerve-interface technology. This approach targets the 85 percent of chronic unilateral vocal fold paralysis patients who retain partial neural innervation, providing a biological basis for electrical reanimation to restore dynamic vocal fold closure and improve voice and airway protection outcomes compared to current surgical alternatives that offer only temporary improvement or require permanent laryngeal alteration.

Performance occurs in West Somerville, Massachusetts. The award period runs through July 31, 2028. This is a Small Business Innovation Research Phase 2 award, an assistance type for domestic small businesses developing innovative research solutions with commercial potential.

Closed-loop stimulation to restore voice and swallowing by reanimating paralyzed vocal folds - this direct to phase 2 sbir proposal will advance the development of a closed-loop electrical stimulation therapy for UVFP to restore natural voice. The most common neurogenic voice disorder is unilateral vocal fold paralysis (UVFP), which can cause a devastating reduction in quality of life. Currently available surgical treatments offer only temporary improvement in voice or involve permanent alterations of the larynx that only partially restore voice or require repeat surgeries. More advanced surgical procedures have not to widespread adoption, leaving 100,000 people every year without good treatment options to restore voice and extend life. Closed-loop electrical stimulation (CLES) has the potential to restore dynamic vocal fold (VF) closure, improving voice and airway protective outcomes for the UVFP patient population. Laryngeal electromyography (L-EMG) studies have shown that about 85% of those with chronic UVFP do not have complete VF denervation, providing the neural basis for CLES to reanimate paralyzed VFS. Several studies have also shown that laryngeal muscles can be effectively stimulated or "paced" to restore dynamic VF opening. Despite these successes, laryngeal pacing devices have thus far only stimulated VF abduction to facilitate breathing and have only used preset patterns of stimulation (open-loop control) rather than sensing and responding to the physiological needs of the individual (closed-loop control). This proposal describes a novel closed-loop laryngeal system for reanimation of VF closure to treat UVFP with electrical stimulation. The proposed CLES system builds upon previously FDA-approved devices, yet includes multiple innovative elements including directional field delivery, closed-loop detect-and-treat capabilities, and ultra-miniaturized size. Aim 1 will custom-design a two-sided injectable micro-paddle (based upon separately funded nerve-net technology) which will delivered through an injectable minimally-invasive catheter, providing independent stimulation amplitudes and parameters on opposite sides of the electrode. Independent stimulation is necessary for naturalistic glottic closure. The two-sided electrodes will be manufactured by a contract manufacturer, and the devices will be tested in cadaver larynxes. Aim 2 will upgrade our existing software, firmware, and hardware to realize closed-loop EMG and actigraphy recording algorithms by the neurostimulator. AIM3 will manufacture devices and perform large-animal safety study and essential performance of the micro-CLES system. The system will be tested using a large animal laryngeal model at MGH hospital. At the end of this program, we will have a micro-CLES product that can be advanced to commercial manufacturing (through CRP) towards a U01 study.