Actively Recruiting
Efficacy and Effectiveness of an Investigational Behind-the-Ear Hearing Device Kit
Led by Sonova AG · Updated on 2026-02-17
20
Participants Needed
2
Research Sites
10 weeks
Total Duration
On this page
Sponsors
S
Sonova AG
Lead Sponsor
N
National Hearing Services Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Effectiveness of an Investigational Behind-the-Ear Hearing Device Kit
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Current and experienced hearing aid users actively using hearing aids for at least 3 months
- Audiograms fitting the device's range: mild to profound bilateral hearing loss
- Ability to consent, operate the device controls, and follow study directions
- Good understanding of English (read, write, speak)
- Willingness to wear binaural behind-the-ear investigational devices for 6-8 hours daily
- Good overall health including healthy outer ears without excessive wax or debris
- Ear canal size and shape suitable for proper device fitting
- Socially active participants frequently encountering noisy situations
- Ownership and use of a smartphone for pairing with hearing aids
- Representative of typical hearing instrument users in age and hearing loss
You will not qualify if you...
- Significant medical conditions likely to interfere with study procedures or confound results
- Known allergy or hypersensitivity to the investigational device or its components
- Limited ability to describe hearing experiences or use of hearing aids
- Acute tinnitus less than three months since onset
- Inability to attend scheduled study visits due to mobility or scheduling issues
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
National Hearing Services Inc
Kitchener, Ontario, Canada, N2E 1Y6
Actively Recruiting
2
National Hearing Services Inc
Mississauga, Ontario, Canada, L5L1J3
Actively Recruiting
Research Team
S
Study Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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