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

December 2, 2025 updated by: Nuance Hearing
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Screening Written informed consent must be obtained for each study subject prior to the commencement of the study. Upon verification of eligibility and execution of informed consent, subjects will be assigned a study code.

The study comprises two groups, stage 1 will include up to 30 participants. Stage 2 will include up to 29 participants. Stage 1 will be conducted before Stage 2, and individuals enrolled in Stage 1 will not be eligible to participate in Stage 2. The eligibility criteria for each group are outlined below.

Screening procedures include:

  • ICF signature and process
  • Eligibility Assessment
  • Data collection: such as Age, Gender, demographic, ENT medical History
  • Otoscopy performed by ENT physician
  • Audiometry (Air conduction and bone conduction thresholds) might be performed as part of any other test day.
  • Spectacle Hearing Aid calibration and Fitting (this activity is subjected to test with Spectacle Hearing Aid ).
  • REM, aided only (optional) might be performed as part of any other test day.
  • Optometrist- for glasses prescription (stage 2 only) Stage 1 :This stage involves hearing evaluation tests , which will be conducted over up to four visits, depending on participant cooperation. Each visit will be scheduled on consecutive days or up to 3 weeks apart, based on the participant's and study staff availability.

Stage 2 : After completing the screening visit, each participant will attend two additional visits. At the enrollment visit, participants will receive their Spectacle Hearing Aid along with the prescribed lenses. They will undergo training using the device and will be asked to fill out questionnaires and performed hearing tests. Additionally, the device application and Electronic Patient-Reported Outcome (ePRO) will be installed on the participants' smartphones, and a demonstration will be provided. Participants will then be required to complete the ePRO daily until the study concludes. Functional auditory test battery will be conducted. Few weeks later, participants will return to complete questionnaires.

Study Type

Interventional

Enrollment (Estimated)

89

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Tel Aviv, Israel
        • Recruiting
        • Asssuta ramat hachayal
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active
Spectacle Hearing Aid
Device: Spectacle Hearing Aid
wearing hearing aid for effectiveness assessment by hearing tests and questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spectacle Hearing Aid effectiveness
Time Frame: 2 weeks
Difference in SNR-50 when performed unaided versus aided using Spectacle Hearing Aid
2 weeks
Spectacle Hearing Aid safety
Time Frame: 2 weeks
Incidence of device or procedure related adverse events
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nuance Hearing

Collaborators

Assuta Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 2, 2025

First Submitted That Met QC Criteria

December 2, 2025

First Posted (Actual)

December 15, 2025

Study Record Updates

Last Update Posted (Actual)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 82CLD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

for confidentiality reasons

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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