Efficacy and Effectiveness of an Investigational Behind-the-Ear Hearing Device Kit
ConditionHearing Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSonova AG
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
Rechargeable behind-the-ear hearing device kit
DeviceThis intervention includes the following components: hearing aid, charger, applicable accessories
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Hearing device kit usersExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Subjective questionnaire feedback
Participants will complete subjective feedback questionnaires: Client Oriented Scale of Improvement (COSI), Online questionnaire, Mobile Application questionnaire. Results will be analyzed descriptively to assess the user experience with the hearing device kit.
Time frame
From enrollment to the end of treatment at 2 weeksSecondary outcomes
1
Hearing in Noise Test (HINT)
An assessment of speech understanding in the presence of background noise in the lab setting.
Time frame
At the end of treatment, after two weeks of device use.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Sonova AG
Lead sponsor
National Hearing Services Inc
Collaborator
Source ClinicalTrials.gov