Rechargeable behind-the-ear hearing device kit for adults with hearing loss
Evaluation of Efficacy and Effectiveness of the Investigational Sonova Behind-the-Ear Rechargeable Hearing Device Kit 2 - 2025
Adults who already use hearing aids will try a rechargeable behind-the-ear hearing device kit for about two weeks to see if it improves listening in noisy places and speech understanding.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sonova AG Industry-sponsored |
| Locations | 2 sites (Kitchener, Ontario and 1 other locations) |
| Trial ID | NCT07414329 on ClinicalTrials.gov |
What this trial studies
This interventional study asks experienced adult hearing-aid users to wear a rechargeable behind-the-ear (BTE/RIC) device kit for approximately two weeks with a minimum daily wear time, paired to their smartphone as needed. Participants receive an initial clinic fitting and complete lab speech-in-noise tests and questionnaires comparing performance with the investigational device to an unaided condition and to their personal hearing device experience. The protocol emphasizes challenging real-world listening situations and collects subjective user-experience data alongside objective speech-understanding measures. Follow-up testing occurs at the end of the wear period to determine whether the device provides measurable and meaningful benefits.
Who should consider this trial
Good fit: Ideal candidates are adults (18+) who are current, experienced hearing-aid users with mild to profound bilateral hearing loss, comfortable using a smartphone, and socially active in noisy settings.
Not a fit: People who are not current hearing-aid users, who have ear-canal issues that prevent fitting, who cannot operate a paired smartphone, or whose hearing falls outside the device fitting range may not receive benefit.
Why it matters
Potential benefit: If successful, the rechargeable BTE kit could help users understand speech better in noisy environments and offer a convenient, satisfactory hearing-aid option.
How similar studies have performed: Similar commercial rechargeable behind-the-ear hearing devices have previously shown modest improvements in user satisfaction and speech-in-noise performance, so the approach is an extension of existing technology rather than entirely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Kitchener, Ontario and 1 other locations
- National Hearing Services Inc — Kitchener, Ontario, Canada (Recruiting)
- National Hearing Services Inc — Mississauga, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Study Manager
- Email: innovation.toronto@sonova.com
- Phone: 519-895-0100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.