NCT07282028

A Prospective, Open-label, Pivotal Study to Assess Spectacle Hearing Aid Safety and Efficacy

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 89 (estimated)
• Sponsor: Nuance Hearing · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Screening Written informed consent must be obtained for each study subject prior to the commencement of the study. Upon verification of eligibility and execution of informed consent, subjects will be assigned a study code. The study comprises two groups, stage 1 will include up to 30 participants. Stage 2 will include up to 29 participants. Stage 1 will be conducted before Stage 2, and individuals enrolled in Stage 1 will not be eligible to participate in Stage 2. The eligibility criteria for each group are outlined below. Screening procedures include: * ICF signature and process * Eligibility Assessment * Data collection: such as Age, Gender, demographic, ENT medical History * Otoscopy performed by ENT physician * Audiometry (Air conduction and bone conduction thresholds) might be performed as part of any other test day. * Spectacle Hearing Aid calibration and Fitting (this activity is subjected to test with Spectacle Hearing Aid ). * REM, aided only (optional) might be performed as part of any other test day. * Optometrist- for glasses prescription (stage 2 only) Stage 1 :This stage involves hearing evaluation tests , which will be conducted over up to four visits, depending on participant cooperation. Each visit will be scheduled on consecutive days or up to 3 weeks apart, based on the participant's and study staff availability. Stage 2 : After completing the screening visit, each participant will attend two additional visits. At the enrollment visit, participants will receive their Spectacle Hearing Aid along with the prescribed lenses. They will undergo training using the device and will be asked to fill out questionnaires and performed hearing tests. Additionally, the device application and Electronic Patient-Reported Outcome (ePRO) will be installed on the participants' smartphones, and a demonstration will be provided. Participants will then be required to complete the ePRO daily until the study concludes. Functional auditory test battery will be conducted. Few weeks later, participants will return to complete questionnaires.

Conditions

• Hearing Loss Mixed

Interventions

Type	Name	Description
DEVICE	Spectacle Hearing Aid	wearing hearing aid for effectiveness assessment by hearing tests and questionnaires

Timeline

• Start date: 2025-07-27
• Primary completion: 2026-11-01
• Completion: 2026-12-01
• First posted: 2025-12-15
• Last updated: 2025-12-15

Locations

1 site across 1 country: Israel