Open-label test of a spectacle hearing aid to check safety and effectiveness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Asssuta ramat hachayal
  Tel Aviv, Israel Recruiting

Study contacts

• Study coordinator: Yael Corcos, MPH
• Email: yael@ay-impact.com
• Phone: 972-54-8106010

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Hearing and Brain Development in Children and Teens

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.