Actively Recruiting
A Prospective, Open-label, Pivotal Study to Assess Spectacle Hearing Aid Safety and Efficacy
Led by Nuance Hearing · Updated on 2025-12-15
89
Participants Needed
1
Research Sites
70 weeks
Total Duration
On this page
Sponsors
N
Nuance Hearing
Lead Sponsor
A
Assuta Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Prospective, Open-label, Pivotal Study to Assess Spectacle Hearing Aid Safety and Efficacy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years and older
- Perceived mild to moderate hearing loss indicated by at least one positive answer to FDA signs: trouble hearing speech in noisy places, difficulty following speech in groups, trouble hearing on the phone, listening causes tiredness, or needing to turn up TV or radio volume
- Wearing corrective glasses for daily use
- Cognitive ability to understand and follow study instructions
- Main language used socially is Hebrew
- Willingness to use the investigational device as instructed during the study
- Ability to use a smartphone
You will not qualify if you...
- Hearing loss greater than 55 dB HL
- Hearing aid use in the last 12 months
- Medical history of cognitive or neurological impairment
- Active inflammatory conditions affecting the ear
- Asymmetric or unilateral hearing loss with more than 15 dB difference between ears in PTA4
- Participation in stage 1 of this study
- Congenital ear defect or deformed/injured ear
- Discharge of blood, pus, or fluid in the past 6 months
- Ear wax that may interfere with REM testing
- Sudden hearing loss in the past 6 months
- Use of electromagnetic medical devices
- Other medical conditions or medications that may affect safety or data collection per principal investigator's opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Asssuta ramat hachayal
Tel Aviv, Israel
Actively Recruiting
Research Team
Y
Yael Corcos, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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