Dover, DE - May 26, 2026 - Fuzzle, a U.S.-based health technology company developing a non-invasive oral weight management system, has received Institutional Review Board approval to begin a randomized controlled clinical trial evaluating its patent-pending intraoral device and behavioral support program as an adjunct to lifestyle counseling for adults with obesity.
The 16-week study will assess whether adding the Fuzzle system, which includes a custom-made removable oral device, weekly coaching, nutrition guidance, and behavioral support, can improve weight-management outcomes compared with lifestyle counseling alone.
The Fuzzle system is designed to support adults with obesity during the moments when food-related cues, cravings, snacking triggers, and automatic eating behaviors often occur. The system includes a custom-made intraoral device worn during the day and removed for meals, along with weekly coaching and structured support.
The device is non-invasive, removable, and designed for at-home use under provider supervision. By modulating oral sensory input, Fuzzle is being studied as a behavioral support tool for people participating in a structured weight-management program.
“Receiving IRB approval is an important step in moving Fuzzle from product development into controlled clinical evaluation,” said Jordan Hidalgo, CMO of Fuzzle. “Obesity is not simply a willpower problem. Many people struggle with food noise, cravings, and what we call accidental snacking, the unplanned eating that happens between planned meals. Fuzzle was designed as a system, not just a device, to help support people in those real-world moments.”
The study will enroll adults ages 18 to 65 with obesity. Participants will be randomized to either use the Fuzzle system in combination with standardized dietary and behavioral support or receive lifestyle counseling alone. The primary objective is to assess whether the addition of the Fuzzle system leads to greater percent total body weight loss at 16 weeks.
The study will also evaluate the proportion of participants who reach predefined weight-management milestones. A subset of participants will provide blood samples for metabolic markers, including HbA1c, hsCRP, and ALT.
According to Fuzzle, the trial represents an important step in building clinical evidence around a non-invasive system designed to fit into everyday routines. By moving into clinical evaluation, the company is working to better understand how its device, combined with nutrition and coaching support, may help adults with obesity build healthier eating habits without surgery or medication.
Fuzzle is also evaluating how its system could eventually fit within broader obesity care pathways. Potential future uses may include behavioral weight management, support before medication-based treatment, adjunctive support alongside clinician-led obesity treatment, and ongoing weight maintenance after medication use. Any future use would depend on clinical results, regulatory review, and provider adoption.
Fuzzle is being evaluated in clinical research and has not been cleared or approved by the FDA for weight management.
For updates and information about Fuzzle, please visit http://www.fuzzle.com.
Social Media Handles: @FuzzleTeam
Media Contact
Company Name: Fuzzle
Contact Person: Logan Lauk
Email: Send Email
Phone: 833-389-9533
Country: United States
Website: http://www.fuzzle.com/
