CompletedNot Applicable

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

Canada20 participantsStarted 2026-01-30

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 descr…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Subjective questionnaire feedback

Timeframe: From enrollment to the end of treatment at 2 weeks

Trial details

NCT IDNCT07414329

SponsorSonova AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-18

View on ClinicalTrials.gov More Hearing Loss trials