NCT07414329 Efficacy and Effectiveness of an Investigational Behind-the-Ear Hearing Device Kit
| NCT ID | NCT07414329 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sonova AG |
| Condition | Hearing Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-01-30 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2026-01-30 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07414329 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hearing Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07414329 currently recruiting?
Yes, NCT07414329 is actively recruiting participants. Contact the research team at innovation.toronto@sonova.com for enrollment information.
Where is the NCT07414329 trial being conducted?
This trial is being conducted at Kitchener, Canada, Mississauga, Canada.
Who is sponsoring the NCT07414329 clinical trial?
NCT07414329 is sponsored by Sonova AG. The trial plans to enroll 20 participants.