Efficacy and Effectiveness of an Investigational Behind-the-Ear Hearing Device Kit

February 9, 2026 updated by: Sonova AG

Evaluation of Efficacy and Effectiveness of the Investigational Sonova Behind-the-Ear Rechargeable Hearing Device Kit 2 - 2025

The goal of this clinical trial is to learn if Sonova's rechargeable behind-the-ear hearing device kit works to treat hearing loss in adults. The main questions it aims to answer are:

  • Does the rechargeable behind-the-ear hearing device kit address challenging listening situations identified by participants while providing a satisfactory user experience?
  • Does the rechargeable behind-the-ear hearing device kit improve speech understanding in noise in a lab setting?

Researchers will compare participants' performance with the rechargeable behind-the-ear hearing device kit to the unaided condition to see if it works to treat hearing loss. The rechargeable behind-the-ear hearing device kit will be subjectively compared to their personal hearing device experience.

Participants will:

  • Use the rechargeable behind-the-ear hearing device kit for approximately 2 weeks.
  • Visit the clinic for the initial fitting and follow-up testing at the end of the study. Additional study visits may take place, as needed.
  • Complete questionnaires to identify challenging listening situations and provide feedback on their experience with the devices.
  • Complete lab testing to assess speech intelligibility in the presence of background noise and provide subjective feedback on features in the Mobile application.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

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

  • Canada
    • Ontario
      • Kitchener, Ontario, Canada, N2E 1Y6
      • Mississauga, Ontario, Canada, L5L1J3

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 or older)
  • Current and experienced hearing aid users (actively using hearing aids for at least 3 months)
  • Audiograms that fit within the fitting range of the devices (mild to profound bilateral hearing loss)
  • Cognitive and functional capability to consent to study procedures, operate the controls for the devices and comply with all directions during the study.
  • Good understanding (read/write/speak) of the English language.
  • Willingness to comply with all study requirements including minimum wear-time (6-8 hrs/day) of binaural BTE(RIC) investigational devices.
  • Good overall health including healthy outer ear with no excessive wax/debris.
  • Ear canal size/shape must accommodate appropriate fitting of the hearing device.
  • Socially engaged participants are a top priority (out & active socially) who frequently encounter the noisy situations in which the devices are meant to be used.
  • Use/ownership of a smartphone to pair hearing aids with for use with phone calls and streaming.
  • Otherwise, the study population is representative of typical hearing instrument users in age and presence of hearing loss

Exclusion Criteria:

  • Significant medical conditions that, in the opinion of the investigators, are likely to interfere with study procedures or likely to confound study endpoint.
  • Contraindications to medical device (MD) in this study: known hypersensitivity or allergy to investigational product/domes.
  • Limited ability to describe listening impressions/experiences and the use of the hearing aid.
  • Acute tinnitus (<three months after onset).
  • Inability to attend scheduled visits (mobility and/or scheduling).

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: Hearing device kit users
Participants will use the rechargeable behind-the-ear hearing device kit for the duration of their study participation in the lab and during their take home trial.
Device: Rechargeable behind-the-ear hearing device kit
This intervention includes the following components: hearing aid, charger, applicable accessories

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective questionnaire feedback
Time Frame: From enrollment to the end of treatment at 2 weeks
Participants will complete subjective feedback questionnaires: Client Oriented Scale of Improvement (COSI), Online questionnaire, Mobile Application questionnaire. Results will be analyzed descriptively to assess the user experience with the hearing device kit.
From enrollment to the end of treatment at 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hearing in Noise Test (HINT)
Time Frame: At the end of treatment, after two weeks of device use.
An assessment of speech understanding in the presence of background noise in the lab setting.
At the end of treatment, after two weeks of device use.

Collaborators and Investigators

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

Sponsor

Sonova AG

Collaborators

National Hearing Services Inc

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)

January 30, 2026

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

April 15, 2026

Study Registration Dates

First Submitted

February 9, 2026

First Submitted That Met QC Criteria

February 9, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRF-33501
  • 401131 (Other Identifier: Health Canada)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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