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RecruitingNCT07282028Updated Dec 15, 2025

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

A Phase 2/3 interventional study of Spectacle Hearing Aid in Hearing Loss Mixed, sponsored by Nuance Hearing. Recruiting at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-15.

Sponsored by Nuance Hearing (part of EssilorLuxottica) · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jul 2025, registered Dec 2025).
  • Started Jul 2025; still recruiting 1 year 3 months later.

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Phase
Phase 2/3
Study type
Interventional
Enrollment
89
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Hearing Loss Mixed

Keywords

  • hearing aid
  • hearing disability
03

In context

Hearing Loss, Mixed Conductive-Sensorineural

44 studies on the registry are indexed under Hearing Loss, Mixed Conductive-Sensorineural; 9 are open to participants now.

This study's planned enrollment of 89 is above the median of 25 across 33 interventional studies indexed under Hearing Loss, Mixed Conductive-Sensorineural.

Browse Hearing Loss, Mixed Conductive-Sensorineural studies →

Lead sponsor

Nuance Hearing is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Browse Nuance Hearing studies →All EssilorLuxottica studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 device according to the instructions for use during the study period
  • Participants must be able to use a smartphone

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
89 participants (estimated)

Study arms

  • Experimental
    Active

    Spectacle Hearing Aid

    Device: Spectacle Hearing Aid

Interventions

  • DeviceSpectacle Hearing Aid

    wearing hearing aid for effectiveness assessment by hearing tests and questionnaires

06

What researchers measure

Primary outcomes

  1. Spectacle Hearing Aid effectiveness

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

    Time frame: 2 weeks

  2. Spectacle Hearing Aid safety

    Incidence of device or procedure related adverse events

    Time frame: 2 weeks

07

Study locations

1 of 1 sites recruiting
  • Asssuta ramat hachayal
    Tel Aviv, Israel
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — for confidentiality reasons

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2025 (actual). Primary completion is estimated for Nov 2026, 16 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 2, 2025
First posted
Dec 15, 2025
StartActual
Jul 27, 2025
Primary completionEst.
Nov 2026
CompletionEst.
Dec 2026
Last update
Dec 15, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07282028
Lead sponsor
Nuance Hearing
Collaborators
Assuta Medical Center
Responsible party
Sponsor
First posted
Dec 15, 2025
Start date
Jul 27, 2025
Primary completion
Nov 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Dec 15, 2025

Study contacts

Yael Corcos, MPH
Contact
yael@ay-impact.com
972-54-8106010

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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