A Prospective, Open-label, Pivotal Study to Assess Spectacle Hearing Aid Safety and Efficacy (NCT07282028) | Clinical Trial Compass
RecruitingPhase 2/3
A Prospective, Open-label, Pivotal Study to Assess Spectacle Hearing Aid Safety and Efficacy
Israel89 participantsStarted 2025-07-27
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 op…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.