Background <p>While there is some research on hypertension self-management programs for individuals with profound hearing loss who use sign language as their primary mode of communication (commonly referred to as Deaf), there is no systematic program that considers their unique needs and health literacy. Given the high prevalence of hypertension among Deaf individuals and their vulnerability to limited health literacy, we developed the Hypertension Self-Management Education for the Hearing-Impaired using Sign Language (H-SMILE) program, focusing on health literacy.</p> Methods <p>Following the Analysis, Design, Development, Implementation, and Evaluation model, this methodological study included: (1) analysis through a systematic review of health education interventions for Deaf populations, a survey of 95 Deaf individuals with hypertension, and in-depth interviews with 10 Deaf sign language users; (2) draft design of the program; and (3) program development and expert validation. A pilot test with five Deaf individuals was conducted to assess feasibility.</p> Results <p>A 12-session program was developed, covering key topics such as the definition of hypertension, dietary management, weight control, exercise, blood pressure monitoring, medication adherence, smoking and alcohol use cessation, and stress management. The program includes eight pre-recorded educational video sessions produced in Korean Sign Language (KSL) and four small-group in-person sessions for review and feedback. Expert validation of the program, including both the sign language videos and the group session materials, showed high content validity (CVI = 0.94). A pilot test with five Deaf individuals with hypertension demonstrated strong engagement, an over-80% completion rate, and satisfaction scores of 5 out of 5 across all evaluated components. The program integrates linguistic, functional, and digital health literacy to ensure a comprehensive and accessible approach for Deaf participants.</p> Conclusions <p>The H-SMILE program is designed for Deaf individuals with hypertension and may be particularly beneficial for those with limited health literacy who use sign language. The program, validated by experts and evaluated in a pilot test showing high satisfaction scores and strong feasibility, appears to be a promising intervention with the potential to enhance health literacy, promote self-management behaviors, and improve health outcomes among Deaf individuals.</p> Trial registration <p>Clinical Research Information Service (CRIS), South Korea (KCT0008292, registration date: March 7, 2023; <a href="https://cris.nih.go.kr/">https://cris.nih.go.kr/</a>).</p>