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Taking peoplePhase 2/3

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

Key facts

Phase
Phase 2/3

This trial has no sites in United States.

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Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Trial details

Who runs it
Nuance Hearing
Trial code
NCT07282028
Record updated
15 December 2025
Original description
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 efficacyRead full original descriptionShow less

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

Inclusion: 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: Prior hearing aid usages for the last 12 months; Medical history of cognitive or neurological impairment; Active inflammatory conditions affecting the ear; Other medical conditions/medications that would interfere with subject safety or data collection in the opinion of the PI; Hearing loss >55 dB HL; 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.

ClinicalTrials.gov NCT07282028