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

NCT07282028 | Recruiting Phase 2

• 1 other identifier: 82CLD
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hearing Loss Mixed

Keywords

hearing aid; hearing disability

Outcome Measures

Primary Outcomes (2)

• Spectacle Hearing Aid effectiveness

  Difference in SNR-50 when performed unaided versus aided using Spectacle Hearing Aid

  2 weeks

• Spectacle Hearing Aid safety

  Incidence of device or procedure related adverse events

  2 weeks

Study Arms (1)

Active

EXPERIMENTAL

Spectacle Hearing Aid

Device: Spectacle Hearing Aid

Interventions

Spectacle Hearing Aid DEVICE

wearing hearing aid for effectiveness assessment by hearing tests and questionnaires

Active

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Assuta Medical Center: collaborator
• Nuance Hearing: lead

Study Sites (1)

Asssuta ramat hachayal

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Mixed Conductive-Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yael Corcos, MPH

CONTACT

972-54-8106010; yael@ay-impact.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 15, 2025
• Study Start: July 27, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)