Efficacy and Effectiveness of an Investigational Behind-the-Ear Hearing Device Kit
Evaluation of Efficacy and Effectiveness of the Investigational Sonova Behind-the-Ear Rechargeable Hearing Device Kit 2 - 2025
2 other identifiers
interventional
20
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2026
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 30, 2026
CompletedFirst Submitted
Initial submission to the registry
February 9, 2026
CompletedFirst Posted
Study publicly available on registry
February 17, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2026
CompletedFebruary 17, 2026
February 1, 2026
2 months
February 9, 2026
February 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Subjective questionnaire feedback
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 Outcomes (1)
Hearing in Noise Test (HINT)
At the end of treatment, after two weeks of device use.
Study Arms (1)
Hearing device kit users
EXPERIMENTALParticipants 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.
Interventions
This intervention includes the following components: hearing aid, charger, applicable accessories
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sonova AGlead
- National Hearing Services Inccollaborator
Study Sites (2)
National Hearing Services Inc
Kitchener, Ontario, N2E 1Y6, Canada
National Hearing Services Inc
Mississauga, Ontario, L5L1J3, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2026
First Posted
February 17, 2026
Study Start
January 30, 2026
Primary Completion
March 31, 2026
Study Completion
April 15, 2026
Last Updated
February 17, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share