A Prospective, Open-label, Pivotal Study to Assess Spectacle Hearing Aid Safety and Efficacy
NCT07282028 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 89
Last updated 2025-12-15
Summary
Following informed consent signature and upon verification of eligibility and execution of informed consent, subjects will be assigned a study code. The study comprises two groups. Screening visit will be conducted for both groups and include hearing test battery to assess hearing aid safety and efficacy
Conditions
- Hearing Loss Mixed
Interventions
- DEVICE
-
Spectacle Hearing Aid
wearing hearing aid for effectiveness assessment by hearing tests and questionnaires
Sponsors & Collaborators
-
Assuta Medical Center
collaborator OTHER -
Nuance Hearing
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-27
- Primary Completion
- 2026-11-30
- Completion
- 2026-12-31
Countries
- Israel
Study Locations
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