RecruitingPhase 2Phase 3NCT07282028
A Prospective, Open-label, Pivotal Study to Assess Spectacle Hearing Aid Safety and Efficacy
Sponsor
Nuance Hearing
Enrollment
89 participants
Start Date
Jul 27, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria7
- 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 Criteria12
- 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
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Interventions
DEVICESpectacle Hearing Aid
wearing hearing aid for effectiveness assessment by hearing tests and questionnaires
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07282028