NCT07282028 A Prospective, Open-label, Pivotal Study to Assess Spectacle Hearing Aid Safety and Efficacy
| NCT ID | NCT07282028 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Nuance Hearing |
| Condition | Hearing Loss Mixed |
| Study Type | INTERVENTIONAL |
| Enrollment | 89 participants |
| Start Date | 2025-07-27 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 89 participants in total. It began in 2025-07-27 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
Inclusion Criteria: * Adults aged 18 years and older * Perceived mild to moderate hearing loss as indicated by at least 1 positive answer to any of the signs specified by FDA: a) You have trouble hearing speech in noisy places, b) You find it hard to follow speech in groups, c) You have trouble hearing on the phone. d) Listening makes youtired, e) You need to turn up the volume on the TV or radio, and other people complain it's too loud * Wearing corrective glasses for daily use * Cognitive ability to understand and follow study instructions. * The main language used in social interactions is Hebrew * Participants must be willing to use the investigational device according to the instructions for use during the study period * Participants must be able to use a smartphone Exclusion Criteria: * Hearing loss \>55 dB HL * Prior hearing aid usages for the last 12 months * Medical history of cognitive or neurological impairment. * Active inflammatory conditions affecting the ear * Asymmetric or unilateral hearing loss - more than 15dB between ears in PTA4- based on screening or hearing test from the last 18 months. * participation in stage 1 study * Congenital ear defect or a deformed or injured ear * In the past 6 months discharge of blood, pus or fluid * Wax that might disturb REM test * Sudden hearing loss in the past 6 months * Wearer of electromagnetic medical device * Other medical conditions/medications that would interfere with subject safety or data collection in the opinion of the PI
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07282028 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hearing Loss Mixed. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07282028 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07282028 currently recruiting?
Yes, NCT07282028 is actively recruiting participants. Contact the research team at yael@ay-impact.com for enrollment information.
Where is the NCT07282028 trial being conducted?
This trial is being conducted at Tel Aviv, Israel.
Who is sponsoring the NCT07282028 clinical trial?
NCT07282028 is sponsored by Nuance Hearing. The trial plans to enroll 89 participants.