A Prospective, Open-label, Pivotal Study to Assess Spectacle Hearing Aid Safety and Efficacy

Recruiting now · Phase 2/Phase 3

Conditions studied: Hearing Loss Mixed

In brief

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

Key facts

Study ID

NCT07282028

Run by

Nuance Hearing

People needed

89

Starts

2025-07-27

Expected to finish

2026-12-01

Last updated by the study team

2025-12-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Asssuta ramat hachayal — Tel Aviv, Israel (enrolling)

Full record on ClinicalTrials.gov

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