Open-label test of a spectacle hearing aid to check safety and effectiveness
A Prospective, Open-label, Pivotal Study to Assess Spectacle Hearing Aid Safety and Efficacy
This will test whether a hearing aid built into eyeglasses helps adults with mild to moderate hearing loss who wear corrective glasses.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 89 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nuance Hearing Industry-sponsored |
| Locations | 1 site (Tel Aviv) |
| Trial ID | NCT07282028 on ClinicalTrials.gov |
What this trial studies
This prospective, open-label pivotal trial enrolls adults with perceived mild to moderate mixed hearing loss who habitually wear corrective glasses and can use a smartphone. The study is conducted in two sequential stages (up to 30 participants in stage 1 and up to 29 in stage 2) with screening, audiometry, device calibration, fitting, and follow-up visits; stage 2 includes optometrist involvement for glasses prescriptions. Outcome measures include standard air- and bone-conduction audiometry and aided measurements, with real-ear measures optional, and safety monitoring by ENT physicians. Participants must be Hebrew speakers and attend in-person visits at the study site in Tel Aviv.
Who should consider this trial
Good fit: Adults aged 18 or older who perceive mild to moderate hearing loss, wear corrective glasses daily, are cognitively able to follow instructions, use a smartphone, and primarily communicate in Hebrew are ideal candidates.
Not a fit: People with hearing loss greater than 55 dB HL, active ear inflammation, significant cognitive or neurological impairment, recent hearing-aid use within the past 12 months, or those who do not wear glasses are unlikely to benefit from this device.
Why it matters
Potential benefit: If successful, the device could improve everyday hearing for people with mild to moderate loss by combining amplification with prescription eyewear, reducing the need for a separate hearing aid.
How similar studies have performed: Some pilot studies and early commercial devices have shown feasibility for spectacle-integrated amplification, but large pivotal efficacy data are still limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tel Aviv
- Asssuta ramat hachayal — Tel Aviv, Israel (Recruiting)
Study contacts
- Study coordinator: Yael Corcos, MPH
- Email: yael@ay-impact.com
- Phone: 972-54-8106010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.