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Completed
NCT07414329
Efficacy and Effectiveness of an Investigational Behind-the-Ear Hearing Device Kit
Conditions: Hearing Loss
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: Sonova AG
Location: National Hearing Services Inc Kitchener Ontario
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 (\
Source: ClinicalTrials.gov (NCT07414329). StuddyBuddy aggregates publicly available trial information.